VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate.

This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc) injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on continued stable co-medication with methotrexate (MTX).

开始日期2011-08-01

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT01147393

/ Terminated临床1/2期IIT

Phase I/II Study of Combination Veltuzumab (Anti-CD20) and Fractionated 90Y- Epratuzumab (Anti-CD22) Radioimmunotherapy in Patients With Follicular Lymphoma

A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also found active in Phase I/II trials.
The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used in combination with veltuzumab. The primary objective is to determine the response rate of this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also be monitored at various times.

开始日期2010-10-01

申办/合作机构

Weill Medical College of Cornell University

[+1]

100 项与维妥珠单抗相关的临床结果

登录后查看更多信息

100 项与维妥珠单抗相关的转化医学

登录后查看更多信息

100 项与维妥珠单抗相关的专利（医药）

登录后查看更多信息

1,364

项与维妥珠单抗相关的文献（医药）

2025-05-01·CLINICAL NEUROLOGY AND NEUROSURGERY

Effective treatment of immune mediated peripheral neuropathy with Ofatumumab - A case report

Article

作者: Hao, Yong ; Zhang, Ying ; Yao, Xiaoying ; Guan, Yangtai ; Jiang, Xianguo ; Zhu, Desheng ; Lin, Yan ; Zhou, Xiajun ; Gao, Meichun ; Ding, Jie

Recurrent immune-mediated peripheral neuropathy is a rare immune disorder that presents significant therapeutic challenges. Ofatumumab (OFA) is a fully humanized anti-CD20 monoclonal antibody with low immunogenicity. We report a patient with recurrent immune-mediated peripheral neuropathy who achieved sustained remission following OFA treatment after multiple relapses. Over a two-year period, the patient experienced over 20 episodes of bilateral upper and lower limb weakness. Furthermore, the patient was unresponsive to intravenous immunoglobulin, plasma exchange, corticosteroids, mycophenolate mofetil, and Telitacicept. Subcutaneous OFA administration resulted in marked reductions in CD19⁺ and CD20⁺ B-cell counts and a relapse-free period exceeding 20 months, with no adverse events observed. This case provides early evidence supporting OFA as a safe and effective alternative for recurrent immune-mediated peripheral neuropathy.

2025-04-01·JOURNAL OF NEUROIMMUNOLOGY

Efficacy of rituximab on antibody-positive small fiber neuropathy: A series of 5 cases

Article

作者: Quek, Amy M L ; Ng, Kay W P ; Chan, Amanda C Y ; Foo, Nicholas ; Sharma, Vijay Kumar ; Schwarz, Herbert ; Ng, Shi-Yang ; Rathakrishnan, Rahul ; Chan, Yee-Cheun ; Shahana, R ; Mak, Anselm ; Siah, Kewin T H

BACKGROUND & AIMS:

We evaluated the efficacy of rituximab in patients with anti-TS-HDS, anti-FGFR3 and anti-plexin D1 small fiber neuropathy (SFN) who failed to respond to conventional treatments and immunotherapy.

METHODS:

We reviewed 111 patients diagnosed with SFN - 83 definite SFN, 9 had positive antibody titers towards TS-HDS, FGFR3 or plexin-D1 and received symptomatic treatment, in addition to trials of intravenous immunoglobulin (IVIg) and/or corticosteroids. Five patients who failed to respond were offered rituximab (two intravenous 1 g infusions, two weeks apart). Clinical parameters and questionnaires were compared.

RESULTS:

Two patients were positive for anti-TS-HDS, one for anti-plexin D1 and two for anti-FGFR3 antibodies. Therapeutic efficacy was assessed by circulating CD19⁺ B cell levels with flow cytometry. Clinical questionnaires, including Visual Analogue Scale (VAS), Rasch Transformed 13-item SFN Symptom Inventory Quotient (RT-SFN-SIQ), Small Fiber Neuropathy-specific Rasch-built overall disability scale (SFN-RODS) and the Composite Autonomic Symptom Scale (COMPASS-31) were obtained prior to rituximab infusion, and at 4 weeks and 4 months post-infusion. Significantly improved VAS was seen at 4 months after rituximab, while a trend towards improvement was seen in RT-SFN-SIQ, and SFN-RODS. COMPASS-31 score remained static.

INTERPRETATION:

This study illustrates the efficacy and potential role of anti-CD20 monoclonal antibody in antibody-associated immune SFN, especially in those who fail to respond to IVIg or corticosteroid. Further randomized controlled trials and larger prospective studies are needed to determine the effectiveness and safety of Rituximab in seropositive patients with SFN.

2025-04-01·JCO Global Oncology

Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda

Article

作者: Kambugu, Joyce ; Towlerton, Andrea M.H. ; Namagembe, Rosemary ; Mubiru, Kelvin R. ; Ddungu, Henry ; Namuli, Prossy ; Puronen, Camille ; Asea, Jacqueline ; Orem, Jackson ; Warren, Edus H. ; Adams, Scott V. ; Menon, Manoj P. ; Uldrick, Thomas S.

PURPOSE:

Patients with diffuse large B-cell lymphoma (DLBCL) who are treated in low-resource settings have inferior outcomes compared with those in high-resource settings. Rituximab, an anti-CD20 monoclonal antibody, when combined with chemotherapy, improves overall survival (OS) for DLBCL. However, in part due to the limited availability of infusion centers in low-resource countries, rituximab is rarely used. Subcutaneous rituximab (sqR) is a potential solution; however, its safety and efficacy have not been tested in low-income countries.

METHODS:

This open-label phase I study enrolled patients 18 years or older with newly diagnosed DLBCL. The first cohort (n = 6) received intravenous rituximab plus CHOP. This cohort received sqR for subsequent cycles. The second cohort (n = 12) received sqR plus CHOP for all cycles. Safety and tolerability were evaluated; secondary outcomes included response rates and treatment completion.

RESULTS:

Between October 25, 2019, and October 7, 2022, 18 patients, with a median age of 36.5 years, were enrolled; 10 were male, and 10 presented with advanced-stage disease. The most common hematologic toxicity was neutropenia (n = 9, 50%). Fifteen of the 18 participants completed treatment; 14 (93.3%) patients achieved a complete response, and one patient (6.7%) had a partial response. The OS and progression-free survival (PFS) at 12 months were 83% (95% CI, 68 to 100) and 67% (95% CI, 48 to 92), respectively. The OS and PFS at 24 months were 66% (95% CI, 47 to 92) and 67% (95% CI, 48 to 92), respectively.

CONCLUSION:

As demonstrated in other parts of the world, sqR together with CHOP was safe, well-tolerated, and efficacious among Ugandan patients with DLBCL. The very high OS rates are nearly double those of historical controls and comparable with outcomes expected in resource-rich settings. This study demonstrated the feasibility, safety, and efficacy of sqR-CHOP, increased the research infrastructure in Uganda, and will improve care in other resource-limited settings.

项与维妥珠单抗相关的新闻（医药）

2025-04-24

·GlobeNewswire-Health Care

[Ad hoc announcement pursuant to Art. 53 LR] Roche continues good momentum into 2025 with 6% (CER) sales growth in the first quarter

Group sales grew by 6%1 at constant exchange rates (CER; 7% in CHF), driven by high demand for newer medicines and diagnostic solutions.Pharmaceuticals Division sales rose by 8% (9% in CHF) on continued strong demand for a broad range of our medicines; top growth drivers were Phesgo (breast cancer), Vabysmo (severe eye diseases), Xolair (allergies) and Hemlibra (haemophilia A).Diagnostics Division sales remained stable with high demand across products and regions offsetting the impact of the recent healthcare pricing reforms in China.Highlights: US approval for Evrysdi tablet for spinal muscular atrophy and Susvimo for the leading cause of diabetes-related blindnessEU approval for Columvi combination with chemotherapy for people with relapsed or refractory diffuse large B-cell lymphomaUS acceptance of supplemental Biologics License Application for Gazyva/Gazyvaro for lupus nephritisTrontinemab for Alzheimer’s disease and NXT007 for haemophilia A to move into phase IIIExclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise amylin analogue as a stand-alone therapy as well as a fixed-dose combination with Roche’s lead incretin asset CT-388 for weight lossUnveiling of novel sequencing by expansion (SBX) technology, a new class of next-generation sequencingAnnouncement of plans to invest USD 50 billion in pharmaceuticals and diagnostics in the US in R&D and manufacturing over the next five yearsAnnouncement of plans to establish Roche Genentech Innovation Center Boston Outlook for 2025 confirmed Roche CEO Thomas Schinecker: “We had a good start to the year with Group sales increasing by 6% at constant exchange rates and we achieved a number of important milestones. Based on recent data, two potential new therapies – our investigational Brainshuttle bispecific antibody to treat Alzheimer’s and our investigational next-generation haemophilia A medicine – will move into phase III. Together with Zealand Pharma, we are developing amylin as a potential new stand-alone therapy for weight loss and as a fixed-dose combination with our incretin CT-388. In Diagnostics, we unveiled our breakthrough ‘sequencing by expansion’ technology, offering unparalleled speed, throughput and flexibility combined with high accuracy. We are expanding our already strong US footprint – with currently over 25,000 employees, 15 R&D and 13 manufacturing sites – by investing USD 50 billion, an important step to continue to meet patient needs in the US with highly innovative medicines and diagnostics. We are confident we will continue our positive momentum and confirm our full-year outlook.” Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Group 15,440 14,399 100.0 100.0 6 7 Pharmaceuticals Division 11,949 10,921 77.4 75.8 8 9 United States 6,224 5,692 40.3 39.5 6 9 Europe 2,320 2,200 15.0 15.3 5 5 Japan 671 649 4.3 4.5 3 3 International* 2,734 2,380 17.8 16.5 18 15 Diagnostics Division 3,491 3,478 22.6 24.2 0 0 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Outlook for 2025 confirmedRoche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Group salesIn the first three months of 2025, Roche achieved sales growth of 6% (7% in CHF) to CHF 15.4 billion. Strong demand for both pharmaceutical products and diagnostic solutions more than made up for the impact from the loss of exclusivity on Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Esbriet (lung disease), Lucentis (severe eye diseases) and Actemra/RoActemra (rheumatoid arthritis, COVID-19), totalling CHF 0.2 billion, and the impact of the recent healthcare pricing reforms in China. Sales in the Pharmaceuticals Division increased by 8% (9% in CHF) to CHF 11.9 billion, with newer medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Vabysmo, Xolair, Hemlibra and Xofluza (influenza) – achieved total sales of CHF 3.6 billion. This represents a plus of CHF 0.7 billion at CER compared to the first quarter of 2024. Phesgo achieved sales of CHF 0.6 billion due to growing demand across regions, notably China and the US, while Vabysmo continued to witness strong uptake, generating sales of CHF 1.0 billion on increased demand in all regions. Sales of Avastin, Herceptin, MabThera/Rituxan, Esbriet, Lucentis and Actemra/RoActemra decreased by a combined CHF 0.2 billion (CER) due to the impact of loss of exclusivity. In the United States, sales rose by 6%. Xolair, Phesgo, Vabysmo, Polivy (blood cancer) and Ocrevus (multiple sclerosis) were the main growth drivers. This growth more than compensated for the reduced sales of medicines with expired patents and the decline in sales of Tecentriq (cancer immunotherapy). Sales in Europe grew by 5% as the strong uptake of Vabysmo, Polivy, Ocrevus, Phesgo and Hemlibra more than compensated for the decline in sales of medicines with expired patents and lower sales of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo. In Japan, sales increased by 3% due to growth in sales of Phesgo, Vabysmo, PiaSky (rare blood disorder), Tamiflu (influenza) and Alecensa (lung cancer). This growth more than compensated for the impact of price cuts as well as biosimilar erosion. Sales in the International region grew by 18%, led by China. In China, sales rose by 14%, driven by demand for Xofluza and Phesgo. The Diagnostics Division sales remained stable at CHF 3.5 billion as growth in demand, notably for immunodiagnostic products and pathology solutions, offset the impact of the recent healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 4% due to higher sales of immunodiagnostic products, clinical chemistry tests and advanced staining solutions. In North America, sales rose by 7%, driven by growth across all customer areas. Sales in Asia-Pacific decreased by 15% due to the impact of the healthcare pricing reforms in China. Pharmaceuticals: key developments Compound Milestone Regulatory ColumviBlood cancer European Commission approves Columvi as the first bispecific antibody for diffuse large B-cell lymphoma (DLBCL) after initial therapy The approval is based on the phase III STARGLO study, where Columvi in combination with chemotherapy showed a 41% reduction in the risk of death compared to MabThera/Rituxan plus chemotherapy.DLBCL is an aggressive cancer with a high risk of progression, meaning urgent and effective treatments are needed for people who relapse or have refractory disease.This Columvi regimen offers a much needed off-the-shelf and fixed-duration treatment option for those ineligible for transplant. More information: Media Release, 14 April 2025 Gazyva/GazyvaroLupus nephritis FDA accepts supplemental Biologics License Application for Gazyva/Gazyvaro for the treatment of lupus nephritis Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal response benefit.The filing application is based on data from the phase III REGENCY study, where Gazyva/Gazyvaro showed superiority over standard therapy alone in people with active lupus nephritis.Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years. More information: Media Release, 5 March 2025 ColumviBlood cancer CHMP recommends EU approval of Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Columvi plus chemotherapy showed a 41% reduction in the risk of death in the pivotal phase III STARGLO study.DLBCL – an aggressive disease with a high risk of progression – remains an area of high unmet need, especially for treatments that can be initiated soon after the cancer returns.If approved, this off-the-shelf, fixed-duration Columvi combination will be the first bispecific antibody regimen available for patients with DLBCL following relapse. More information: Media Release, 28 February 2025 EvrysdiSpinal muscular atrophy FDA approves Evrysdi tablet as first and only tablet for spinal muscular atrophy (SMA) Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries.Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution.New tablet formulation may provide greater freedom and independence for people with SMA thanks to simplified dose administration. More information: Media Release, 12 February 2025 SusvimoSevere eye diseases FDA approves Susvimo as the first and only continuous-delivery treatment for the leading cause of diabetes-related blindness Susvimo is the first and only continuous-delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME).With as few as two treatments per year, Susvimo may help people with DME maintain their vision.Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD). More information: Media Release, 4 February 2025 Phase III, pivotal and other key read-outs TrontinemabAlzheimer’s disease Roche presents novel therapeutic and diagnostic advancements in Alzheimer’s at AD/PD 2025 New trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in phase Ib/IIa Brainshuttle AD study.Data on the Elecsys pTau181 plasma test demonstrate potential to accurately rule out amyloid pathology, one of the hallmarks of Alzheimer’s disease.Roche will initiate a phase III programme for trontinemab later this year based on totality of data. More information: Media Release, 3 April 2025 OcrevusMultiple sclerosis Roche provides update on phase III Ocrevus high dose study in people with relapsing multiple sclerosis MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis.The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression.High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals observed. More information: Media Release, 2 April 2025 XolairAllergies Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies First-ever head-to-head trial comparing Xolair and oral immunotherapyResults were featured as late-breakers at the 2025 AAAAI Annual Meeting.Xolair is the only US FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies. More information: Media Release, 2 March 2025 Other US investment announcement Roche announces plans to invest USD 50 billion in pharmaceuticals and diagnostics in the United States over the next five years USD 50 billion commitment includes new state-of-the-art research and development (R&D) sites, new and expanded manufacturing facilities in Indiana, Pennsylvania, Massachusetts and California and an additional site location to be announced soon.Investments will create more than 12,000 new jobs: 1,000 at Roche and more than 11,000 in support of new US manufacturing capabilities. Roche already has a significant existing US presence with more than 25,000 employees, 15 R&D centres and 13 manufacturing sites. More information: Media Release, 22 April 2025 Zealand Pharmaagreement Roche enters into an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide as a potential foundational therapy for people with overweight and obesity Agreement allows for a range of potentially best-in-class therapy options as monotherapy and fixed-dose combination with Roche’s lead incretin asset CT-388.Collaboration will complement Roche’s portfolio in the field of cardiovascular, renal and metabolic (CVRM) diseases.Obesity is a heterogeneous disease with over 200 related comorbidities, including cardiovascular and metabolic diseases, and is expected to impact over 4 billion people globally by 2035. More information: Media Release, 12 March 2025 Roche Genentech Innovation Center Roche announces launch of Roche Genentech Innovation Center Boston based at Harvard’s Enterprise Research Campus in Allston The new centre will be a hub for both Roche and Genentech, bringing together expertise in cardiovascular, renal and metabolic diseases, as well as for data science and AI specialists to drive innovation in drug discovery and development.Roche will be the first to join Harvard’s Enterprise Research Campus in Allston, taking a suite in the first phase of the project’s cutting-edge lab space.Starting with a lease of 30,000 square feet (approx. 2,800 square metres), Roche intends to invest over the coming years into a research and development presence with eventually up to 500 employees. More information: Media Release, 7 March 2025 Gazyva/GazyvaroLupus nephritis New England Journal of Medicine publishes new data for Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis Nearly half of patients on Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR), with a statistically significant and clinically meaningful improvement, compared to standard treatment alone.Analysis showed consistent CRR benefit across patient subgroups, highlighting potential to treat a broad patient population with high unmet need.Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a phase III study to demonstrate CRR benefit, which is associated with preservation of kidney function and delay or prevention of end-stage kidney disease. More information: Media Release, 7 February 2025 Enlarged Corporate Executive Committee change Change to the Roche Enlarged Corporate Executive Committee Wafaa Mamilli joins Roche as Chief Digital Technology Officer (CDTO), reporting to Group CEO Thomas Schinecker.She became a member of the Enlarged Corporate Executive Committee starting 10 February 2025. She is based at Genentech in South San Francisco. More information: Media Release, 29 January 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 11,949 10,921 100.0 100.0 8 9 United States 6,224 5,692 52.1 52.1 6 9 Europe 2,320 2,200 19.4 20.1 5 5 Japan 671 649 5.6 5.9 3 3 International 2,734 2,380 22.9 21.9 18 15 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 1,778 6 1,247 3 344 11 - - 187 16 HemlibraHaemophilia A 1,165 11 610 0 247 7 82 3 226 72 VabysmoEye diseases (nAMD, DME, RVO) 1,018 18 718 7 197 42 32 35 71 101 TecentriqCancer immunotherapy 870 0 411 -8 220 5 81 -5 158 21 Perjeta2Breast cancer 840 -10 342 -3 144 -16 18 -51 336 -9 Xolair2Asthma 645 26 645 26 - - - - - - Actemra/RoActemra2RA, COVID-19 619 -1 294 3 152 -19 71 5 102 26 PhesgoBreast cancer 593 52 179 38 199 18 40 115 175 142 Kadcyla2Breast cancer 506 5 201 5 135 -7 21 -3 149 21 EvrysdiSpinal muscular atrophy 420 18 160 15 145 6 20 0 95 56 AlecensaLung cancer 397 11 130 21 68 -6 49 12 150 12 PolivyBlood cancer 358 42 156 30 94 74 44 2 64 80 MabThera/Rituxan2Blood cancer, RA 298 -16 181 -14 35 -10 3 -17 79 -23 Activase/TNKase2Cardiac diseases 297 -2 285 -2 - - - - 12 -9 Herceptin2Breast and gastric cancer 292 -20 60 -12 77 0 2 -56 153 -29 Avastin2Various cancer types 274 -15 80 -21 14 -33 36 -30 144 -3 Gazyva/Gazyvaro2Blood cancer 249 15 131 27 60 -3 8 46 50 11 XofluzaInfluenza 159 234 14 239 - * - - 145 234 Pulmozyme2Cystic fibrosis 123 10 84 22 18 -9 - -26 21 -10 Tamiflu2Influenza 100 56 9 * 26 114 13 81 52 17 * Over 500%DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone SBX technology Roche unveils a new class of next-generation sequencing with its novel sequencing by expansion technology Roche’s innovative sequencing by expansion (SBX) technology represents a leap forward in next-generation sequencing (NGS), which is playing a vital role in decoding complex diseases like cancer, immune disorders and neurodegenerative conditions.Combined with an innovative, high-throughput sensor module, SBX uses expanded synthetic molecules to determine the DNA sequence of a target molecule, creating an ultra-rapid, scalable and flexible technology.Reducing the time from sample to genome from days to hours, this novel approach could significantly speed up genomic research, as well as translational and clinical applications in the years to come. More information: Media Release, 20 February 2025 PATHWAY HER2 (4B5) test Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU As seen in the DESTINY-Breast06 trial, approximately 20–25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow. These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes.The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low and now HER2-ultralow classifications, Roche continues to lead in HER2 diagnostics, helping to expand patient access to personalised treatment. More information: Media Release, 31 January 2025 Diagnostics sales Sales CHF millions As % of sales % change January–March 2025 2024 2025 2024 At CER In CHF Diagnostics Division 3,491 3,478 100.0 100.0 0 0 Customer areas3 Core Lab 1,904 1,926 54.5 55.4 -1 -1 Molecular Lab 634 611 18.2 17.6 2 4 Near Patient Care 536 569 15.4 16.3 -5 -6 Pathology Lab 417 372 11.9 10.7 11 12 Regions Europe, Middle East, Africa 1,236 1,188 35.4 34.2 4 4 North America 1,154 1,055 33.1 30.3 7 9 Asia-Pacific 853 992 24.4 28.5 -15 -14 Latin America 248 243 7.1 7.0 11 2 More information on Roche performance in the first quarter of 2025: Q1 2025 presentationAppendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharmaceuticals with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2024) and all total figures quoted are reported in CHF.[2] Products launched before 2015.[3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly.In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly. Cautionary statement regarding forward-looking statementsThis document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media RelationsPhone: +41 61 688 88 88 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 687 52 84e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 688 80 27e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 688 48 14e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachments 25042025_Roche_Q1_2025_EN Communications appendix tables_Q1 2025 Sales

临床3期临床结果上市批准高管变更引进/卖出

2024-12-09

·Business Wire

Kite’s Yescarta® Only CAR T-Cell Therapy to Show Durable Response and Long-Term Survival After Five Years in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas at ASH 2024

SANTA MONICA, Calif.--( BUSINESS WIRE )--Kite, a Gilead Company (Nasdaq: GILD), today announced results from a five-year follow-up analysis of ZUMA-5, a Phase 2 study of Yescarta ® (axicabtagene ciloleucel) in patients with relapsed/refractory non-Hodgkin lymphomas (NHL) including follicular lymphoma (FL) or marginal zone lymphoma (MZL). The analysis demonstrated that after a median follow-up of more than five years, patients treated with Yescarta continued to experience durable response and long-term survival. The data were shared in an oral presentation (Abstract #864) during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. “ Relapsed or refractory non-Hodgkin lymphomas, including follicular lymphoma and marginal zone lymphoma, are generally considered to be incurable, with most patients ultimately relapsing,” said Dr. Sattva S. Neelapu, lead investigator, The University of Texas MD Anderson Cancer Center. “ These impressive results demonstrate the continued durable clinical benefit and manageable long-term safety profile of axi-cel and give us hope that it may have a curative effect on these difficult-to-treat blood cancers.” In ZUMA-5, 159 patients were enrolled (127 FL, 31 MZL, 1 DLBCL [later excluded]). At a median follow-up of 64.6 months (range, 32.3-81.4; FL: 65.7, MZL: 55.8), the overall response rate (ORR) was 90% and the complete response (CR) was 75%. Among patients who achieved a CR, 58% remained in CR at the time of data cutoff. The median duration of response (DOR) was 60.4 months (95% CI, 39.7-not estimable [NE]; FL: 60.4, MZL: not reached [NR]), with estimated 60-month DOR of 53.4% (95% CI, 43.9-62.0; FL: 52.2%, MZL: 60.0%). Median progression-free survival (PFS) was 62.2 months (95% CI, 34.9-NE; FL: 57.3, MZL: NR). PFS rates at 60 months in patients with FL were consistent regardless of high-risk characteristics. Median time to next therapy was NR in all patients with NHL (95% CI, 38.6-NE; consistent by disease type), with a 60-month estimated rate of 53.3% (95% CI, 45.0-60.9; FL: 54.0%, MZL: 50.9%). At data cutoff, 55% of patients (n=87) were alive with no new anticancer therapy. The median overall survival (OS) was NR (95% CI, NE-NE; consistent by disease type), and the 60-month OS estimate was 69.0% (95% CI, 60.8-75.8; FL: 68.9, MZL: 71.1). “ There is growing evidence that people with follicular lymphoma and marginal zone lymphoma can experience long-term survival after one Yescarta treatment,” said Dominique Tonelli, VP, Global Head of Medical Affairs, Kite. “ With no lymphoma-specific events in the five-year follow-up of ZUMA-5 patients, Yescarta may offer patients the chance to live longer without need for subsequent therapy and a potential cure.” No new Yescarta-related safety signals emerged in the five-year analysis. One patient progressed after the data cutoff of the four-year analysis and no patients died of disease progression after the prior analysis. Among treated patients (n=152, 124 FL, 28 MZL), three new events not related to Yescarta were reported after the four-year analysis, including Grade 3 metastasis, Grade 1 bladder cancer, and Grade 4 myelodysplastic syndrome (a serious adverse event). One patient died of pneumonia, unrelated to Yescarta. At any time on trial, a total of 46 patients died, due to progressive disease (n=14), secondary malignancies (n=6), infections (n=11), or another or unknown cause (n=15). About ZUMA-5 ZUMA-5 is a single-arm, open-label, international, multicenter Phase 2 study evaluating 159 adult patients with R/R NHL (FL and MZL) who received at least two prior lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. The primary endpoint was ORR, and secondary endpoints included CR rate, ORR and CR in patients who had received three or more lines of prior therapy, DOR, OS, PFS and incidence of adverse events. About NHL FL and MZL are both forms of indolent NHL in which malignant tumors slowly grow but can become more aggressive over time. FL is the most common form of indolent lymphoma and the second most common type of lymphoma globally. It accounts for approximately 22 percent of all lymphomas diagnosed worldwide. MZL is the third most common lymphoma, accounting for 8 to 12 percent of all B-cell NHLs. Despite advances in management and substantial improvements in long-term survival, patients living with FL have varied outcomes. Currently, there are limited options for the treatment of relapsed or refractory FL and MZL after two or more lines of therapy. About Yescarta Please see full Prescribing Information , including BOXED WARNING and Medication Guide. YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). U.S. IMPORTANT SAFETY INFORMATION BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids, as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program. CYTOKINE RELEASE SYNDROME (CRS) CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL) receiving YESCARTA, including ≥ Grade 3 (Lee grading system1) CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 CRS in 9%. Among patients with LBCL who died after receiving YESCARTA, four had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1 to 10 days) and the median duration was 7 days (range: 2 to 43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, one patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1 to 20 days) and the median duration was 6 days (range: 1 to 27 days) for patients with iNHL. Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) . The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in two subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events. CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1 to 8 days) and the median duration of CRS was 7 days (range: 2 to 16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS at which point the patients were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 or higher CRS. The median time to onset of CRS was 5 days (range: 1 to 15 days) and the median duration of CRS was 4 days (range: 1 to 10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities. Ensure that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. NEUROLOGIC TOXICITIES Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life- threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL. The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred. The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS. Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly. REMS Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483). HYPERSENSITIVITY REACTIONS Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA. SERIOUS INFECTIONS Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 or higher infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. PROLONGED CYTOPENIAS Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion. HYPOGAMMAGLOBULINEMIA B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment. SECONDARY MALIGNANCIES Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period. ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting. The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias. The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness. About Kite Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on achieving cures with cell therapy. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing. For more information on Kite, please visit www.kitepharma.com . About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Gilead acquired Kite in 2017. Forward-Looking Statements This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta (such as ZUMA-5); uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. Yescarta, Gilead, the Gilead logo, Kite, the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information on Kite, please visit the company’s website at www.kitepharma.com . Follow Kite on social media on X (@KitePharma) and LinkedIn .

临床结果临床2期ASH会议免疫疗法细胞疗法

2024-06-11

·SYNAPSE

Global New Drug Research and Development Progress Weekly Report(6.3-6.9)

Global Pharmaceutical Research and Development Progress1.Roche's Oral Highly Selective PI3Kα Inhibitor Inavolisib Submitted for Marketing Approval in China On June 3rd, the CDE website showed that Roche's PI3Kα inhibitor Inavolisib (GDC-0077) has been submitted for marketing approval in China. It is intended for use in combination with palbociclib and fulvestrant for the treatment of adult patients with locally advanced or metastatic breast cancer who have a PIK3CA mutation, are hormone receptor-positive (HR+), and human epidermal growth factor receptor 2-negative (HER2-), and have experienced a recurrence within 12 months after adjuvant endocrine therapy or after completing such therapy. Recently, Roche also submitted a marketing application for this drug to the FDA. In December 2023, Roche presented the results of the Phase III INAVO120 trial of Inavolisib for the treatment of breast cancer at the San Antonio Breast Cancer Symposium (SABCS). This study is a randomized, double-blind, placebo-controlled clinical trial (n=325) that evaluated the efficacy and safety of Inavolisib combined with palbociclib and fulvestrant compared to placebo combined with palbociclib and fulvestrant in adult patients with PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer. The primary endpoint of the study was progression-free survival (PFS). The results showed a statistically and clinically significant extension in median PFS for patients in the Inavolisib group compared to the placebo group (15.0 vs. 7.3 months, HR=0.43, P<0.0001). Overall survival (OS) data are still immature, but a significant positive trend has been observed (NE vs. NE, HR=0.64, P=0.0338), and further follow-up is underway, with anticipation for the next analysis. Approximately 40% of HR+ metastatic breast cancer patients have a PIK3CA gene mutation. This mutation can lead to the alteration of the PI3Kα protein, resulting in uncontrolled tumor growth, disease progression, and resistance to endocrine therapy. Inavolisib is an oral, highly selective PI3Kα inhibitor that demonstrates greater selectivity and potency for PI3Kα compared to other isoforms (PI3Kβ/δ/γ) and can specifically trigger the degradation of mutated PI3Kα protein. 2.Agios' Oral Therapy for Thalassemia, Mitapivat, Meets Primary Endpoint in Phase III Study On June 3, Agios announced that its Phase III ENERGIZE-T study of mitapivat in adult patients with transfusion-dependent (TD) α- or β-thalassemia met its primary endpoint, significantly reducing the need for transfusions. Mitapivat is a first-in-class, oral pyruvate kinase-R (PKR) activator that activates both wild-type and mutant PKR, improving the energy supply and health of red blood cells. In February 2022, mitapivat received its first FDA approval for treating adult hemolytic anemia caused by pyruvate kinase (PK) deficiency, making it the first disease-modifying therapy for this condition, marketed under the brand name Pyrukynd. The Phase III ENERGIZE-T study included 258 patients, with 155 in the mitapivat group and 83 in the placebo group, completing the 48-week double-blind study phase. The results showed that the study achieved its primary endpoint of transfusion reduction response (TRR). TRR is defined as a reduction of ≥50% in red blood cell (RBC) transfusion units over any consecutive 12-week period by Week 48 compared to baseline, equating to a reduction of ≥2 RBC units. Mitapivat significantly reduced the transfusion burden compared to placebo, with 30.4% of patients in the mitapivat group achieving TRR, compared to only 12.6% in the placebo group (bilateral p=0.0003). 3.Arrowhead's Investigational Long-Acting Therapy Plozasiran Achieves Primary Endpoint in Phase 3 Clinical Trial June 4, Arrowhead Pharmaceuticals announced topline results from the pivotal Phase 3 clinical trial PALISADE, evaluating its investigational therapy plozasiran in patients diagnosed with familial chylomicronemia syndrome (FCS). The data indicated that plozasiran successfully met the primary endpoint of triglyceride reduction, with up to a 99% decrease observed at month 12. Plozasiran also achieved all key secondary endpoints, including a reduction in the incidence of acute pancreatitis compared to placebo. The primary endpoint of the PALISADE study was the median percentage change in triglyceride levels from baseline to month 10, adjusted for placebo. At this time point, patients receiving quarterly doses of 25 mg or 50 mg of plozasiran achieved a median triglyceride reduction of 80% and 78%, respectively, with maximum reductions reaching up to 98%. At month 12, patients on 25 mg or 50 mg of plozasiran achieved a median triglyceride reduction of 78% and 73%, respectively, with maximal reductions reaching up to 99%. In contrast, patients receiving placebo showed median triglyceride level reductions of 17% and 7% at months 10 and 12, respectively. At month 10, patients in the 25 mg and 50 mg plozasiran groups had average reductions in apolipoprotein C-III (APOC3) levels of 88% and 94%, respectively. 4.InnoCare Pharma's Anti-CD19 Monoclonal Antibody Tafasitamab to be Considered for Priority Review for Treating Hematological Cancers On June 4, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) revealed that InnoCare Pharma's application for injectable tafasitamab is to be considered for priority review. The indication is for the combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). Tafasitamab is a humanized monoclonal antibody targeting CD19 with an optimized Fc domain. DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL), accounting for 31% to 34% of NHL cases worldwide. According to the Chinese Society of Hematology, DLBCL accounts for 45.8% of all NHL cases in China. According to information published by InnoCare Pharma, tafasitamab is a humanized monoclonal antibody targeting CD19 with an optimized Fc domain. The unique engineered Fc domain of tafasitamab significantly enhances antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), mediating the lysis of B-cell tumors through apoptosis and immune effector mechanisms. 5.Johnson & Johnson's Bispecific Antibody Rybrevant Shows Positive Phase 3 Results in First-Line Combination Therapy On June 4, Johnson & Johnson Innovative Medicine announced new data from the Phase 3 MARIPOSA study. The analysis revealed that their bispecific antibody Rybrevant (amivantamab), in combination with the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) oral drug lazertinib, significantly improves progression-free survival (PFS) in subgroups of high-risk adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion (ex19del) or L858R substitution mutations compared to the active comparator. Specifically, the combination of amivantamab and lazertinib demonstrated a significant reduction in the risk of disease progression or death in all high-risk subgroups when compared to the active comparator TKI drug Tagrisso (osimertinib). For patients with a history of brain metastases, PFS was 18.3 months with the amivantamab combination therapy versus 13.0 months for the active comparator group, representing a 31% reduction in the risk of disease progression or death (HR=0.69, 95% CI: 0.53-0.92; P=0.010). In patients with baseline liver metastases, PFS was 18.2 months for the amivantamab combination therapy compared to 11.0 months for the active comparator group, resulting in a 42% reduction in the risk of disease progression or death (HR=0.58, 95% CI: 0.37-0.91; P=0.017). 6.GSK Announces Impressive Data for Jemperli in First-Line Treatment of Rectal Cancer On June 4, GSK announced updated long-term data from its Phase 2 clinical trial of the PD-1 inhibitor Jemperli (dostarlimab) as a first-line therapy replacing surgery for mismatch repair deficient (dMMR) locally advanced rectal cancer. According to the press release, the trial demonstrated a 100% clinical complete response rate (cCR) in 42 patients who completed Jemperli treatment. Sustained clinical complete responses were observed in the first 24 evaluated patients over a median follow-up of 26.3 months. Detailed data were presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting. Other registration trials for Jemperli in the treatment of dMMR/microsatellite instability-high (MSI-H) rectal and colorectal cancer (CRC) are currently recruiting patients. Rectal cancer, which originates in the rectum (the final part of the large intestine), is often classified as a type of colorectal cancer. Colorectal cancer is the third most commonly diagnosed cancer worldwide. Approximately 5-10% of rectal cancers are dMMR/MSI-H, characterized by mutations that affect the proper repair of DNA during cell replication. The dMMR status is a biomarker that has been shown to predict responsiveness to immune checkpoint blockade therapies such as PD-1 antibodies. 7.Philogen and Sun Pharmaceutical Submit MAA for Nidlegy, Their First Immunocytokine Product, in Europe On June 4, Philogen and Sun Pharmaceutical jointly announced that they have submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for daromun (trade name: Nidlegy). This submission is for the neoadjuvant treatment (i.e., pre-surgical treatment) of locally advanced, fully resectable melanoma. If approved, Nidlegy will become the first marketed immunocytokine product. The MAA is primarily based on the positive outcomes from the Phase III PIVOTAL study and a Phase II study. The PIVOTAL study is a randomized, multicenter, open-label, controlled clinical trial (n=256) that evaluated the efficacy and safety of neoadjuvant treatment (i.e., Nidlegy) followed by surgery compared to surgery alone in patients with Stage IIIB/C melanoma. The primary endpoint was the proportion of patients who achieved relapse-free survival (RFS) at one year. The results demonstrated a 41% reduction in the risk of relapse or death in the Nidlegy group (HR=0.59, p=0.005), with median RFS more than doubling (16.7 vs. 6.9 months). Distant metastasis-free survival (DMFS) was also significantly extended (HR=0.60, p=0.029). Additionally, 21% of patients in the Nidlegy group achieved pathological complete response (pCR). 8.Viking's Innovative Therapy Thyroid Hormone Receptor Beta Subtype Agonist VK2809 Achieves Primary and Secondary Endpoints On June 5, Viking Therapeutics announced positive 52-week histological data from its Phase 2b VOYAGE study of the novel liver-selective thyroid hormone receptor beta (TRβ) agonist VK2809. The study, conducted in patients with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH)/non-alcoholic steatohepatitis (NASH), previously demonstrated that the primary endpoint was met. Compared to placebo, patients receiving VK2809 exhibited a statistically significant reduction in liver fat content from baseline to week 12. Today’s announcement reveals that secondary endpoints were also met: 52-week liver biopsy assessments showed that up to 75% of patients treated with VK2809 achieved NASH resolution without fibrosis worsening, and up to 88% experienced significant liver fat reduction. The VOYAGE study is a randomized, double-blind, placebo-controlled, multi-center international trial designed to evaluate the efficacy, safety, and tolerability of VK2809 in patients confirmed by biopsy to have NASH and liver fibrosis. The enrolled patients include those with a liver fat content of at least 8%, as measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF), and those with F2 and F3 fibrosis stages. VK2809 is an orally administered TRβ tissue- and receptor-subtype-specific agonist with liver and beta receptor subtype selectivity. It holds substantial therapeutic potential for a range of lipid disorders. VK2809 belongs to a novel class of prodrugs, which are cleaved in vivo to release a potent thyromimetic. The selective activation of TRβ receptors in liver tissue is believed to exert significant effects on cholesterol and lipoprotein levels through various mechanisms, including the upregulation of genes involved in lipid metabolism and clearance. 9.Gilead Announces Positive Long-term Results of Investigational Small Molecule Seladelpar On June 6th, Gilead Sciences announced the two-year interim results of the ongoing ASSURE study. The analysis indicated that adult patients with moderate to severe primary biliary cholangitis (PBC) receiving treatment with their investigational drug seladelpar experienced rapid and sustained reduction in patient-reported pruritus. Subgroup analysis for subjects with compensated cirrhosis showed clinically meaningful improvements in markers of cholestasis and liver injury. The U.S. FDA has accepted the new drug application for seladelpar for the treatment of PBC patients and granted it priority review status. This includes use for the treatment of pruritus as well as for adult patients with non-cirrhotic or compensated cirrhotic PBC who have had an inadequate response to or intolerance of ursodeoxycholic acid (UDCA). The FDA is expected to announce its review decision by August 14, 2024. Additionally, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) have also accepted the marketing authorization applications for seladelpar. Primary biliary cholangitis is a potentially life-threatening autoimmune liver disease. The disease results in the progressive destruction of bile ducts due to continuous immune system attacks, causing cholestasis, retention of toxic bile acids within the liver, and can progress to liver fibrosis, cirrhosis, and liver failure. 10.The first human trial results of Virion's potential "first-in-class" immunotherapy are positive On June 6th, Virion Therapeutics announced early positive immunological and safety data from the first human clinical trial of its potential "first-in-class" checkpoint-modified immunotherapy, VRON-0200. This therapy aims for the functional cure of chronic Hepatitis B virus (HBV) infection. Results demonstrated that VRON-0200 exhibited good safety and tolerability, with no reported significant adverse events and no clinically relevant abnormalities detected in laboratory tests, including liver function tests. Among the nine patients with at least 28 days of immunological follow-up, the majority (n=5) showed enhanced T-cell responses post-treatment, and several patients maintained T-cell responses above baseline levels by day 91. VRON-0200 is an intramuscularly administered therapeutic immunotherapy designed to provide a functional cure for patients with chronic HBV infection. It utilizes an adenoviral vector to express HBV antigens in antigen-presenting cells while also expressing a recombinant protein that modulates checkpoint signaling pathways. Preclinical data indicate that VRON-0200 can amplify, broaden, and enhance T-cell responses by modulating checkpoint signaling pathways, potentially including T-cells that are typically not activated during chronic HBV infection, thereby improving viral control. For more information on the progress of drug development, please follow the Synapse database. Dynamics of Global Pharmaceutical Trade Cooperation1.Akeso Biopharma and Summit Further Expand Collaboration On June 3rd, Akeso Biopharma announced the signing of a supplemental license agreement with Summit Therapeutics. This agreement expands the licensed market scope for Ivonescimab, a PD-1/VEGF bispecific antibody, under their original collaboration agreement. According to the supplemental license agreement, Akeso Biopharma will receive an upfront payment and milestone payments totaling $70 million, along with royalties on sales of Ivonescimab in the newly licensed markets. The royalty rate remains consistent with the terms of the initial agreement signed on December 5, 2022. Akeso Biopharma will continue to supply Ivonescimab injection for all licensed markets, including the newly added ones, and will earn revenue from these supplies. Furthermore, the supplemental agreement strengthens the cross-regional collaboration terms, including the sharing of clinical trial data and regulatory submission documents, to expedite Ivonescimab's regulatory approval and commercialization worldwide. Summit will gain exclusive rights for the development and commercialization of Ivonescimab in North America, South America, the Middle East, and Africa. Summit will also remain responsible for the clinical development, product registration, and commercialization in all licensed regions, as well as all associated costs. 2.Alphamab and ArriVent Collaborate to Develop New ADC Drug On June 5, Alphamab Oncology announced the signing of a research and collaboration agreement with ArriVent BioPharma, Inc. Under the terms of the agreement, Alphamab will collaborate with ArriVent to utilize Alphamab's proprietary linker-payload platform (Alphatecan) and glycosylation site-specific conjugation platform to discover and develop new Antibody-Drug Conjugates (ADCs). Alphamab will retain the rights to develop and commercialize the ADC products within Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (collectively, Greater China). Outside of Greater China, ArriVent will hold exclusive rights to develop and commercialize the related ADC products in the oncology field and will be responsible for bearing the corresponding development expenses. According to the agreement, Alphamab is entitled to receive a one-time, non-refundable upfront payment and potential milestone payments, which include milestones for product registration, development, and sales, with total payments up to $615.5 million. Additionally, Alphamab will also be entitled to tiered royalties based on the sales of each ADC product. The ADC domain has become a front-runner for domestic innovative drugs and technology platforms entering the international market. Recently, BioNTech introduced YLL Biotech's ADC technology, with a total cooperation amount reaching up to $1.8 billion. In this collaboration, Alphamab and ArriVent's agreement amounts to $615.5 million. The commercial rights arrangements for the two cooperations are slightly different. BioNTech holds global rights while YLL Biotech reserves the option for Greater China rights. In contrast, Alphamab retains direct rights for Greater China in its deal with ArriVent. 3.BMS to Lay Off 863 Employees to Save $1.5 Billion in Expenses Starting this month, Bristol-Myers Squibb (BMS) has initiated a new round of layoffs, cutting approximately 863 positions in Lawrenceville, New Jersey. Previously, in March, BMS had already laid off 75 employees in Lawrenceville. During the announcement of its first quarter financial results in April, BMS disclosed a cost reduction plan aimed at saving approximately $1.5 billion by the end of 2025. The company estimated that around 2,200 employees would be affected by the cost-cutting measures in 2024. This round of layoffs signals the official commencement of BMS's $1.5 billion savings plan. BMS has not specified the types of positions affected by this layoff nor which facility in Lawrenceville will see the cuts. According to available information, BMS has two sites in Lawrenceville: one located on Route 206 and the other on Princeton Pike. The Route 206 facility is equipped with early discovery laboratories, offices, and support services, where scientists are dedicated to discovering and developing therapies for cancer, immunology, cardiovascular diseases, and fibrosis. The Princeton Pike location houses BMS's business teams as well as partners from the R&D, product development, and supply departments. During the Q1 earnings report, BMS pointed out that the $1.5 billion cost-cutting plan involves the restructuring of organizational management and optimizing the product pipeline. At the time, the company's Chief Financial Officer David Elkins stated that reducing R&D spending would contribute two-thirds of the savings. Chief Medical Officer Samit Hirawat also added that BMS is deciding to terminate work on about a dozen clinical projects, including the follow-up version of the immunotherapy Yervoy, as well as SIRPα and BET targeted therapies. Moving forward, the company will focus on assets and projects with higher investment returns.

100 项与维妥珠单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D09031	维妥珠单抗	-	DB05656

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肿瘤	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	加拿大	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	捷克	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	德国	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	匈牙利	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	意大利	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	墨西哥	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	波兰	Takeda Pharmaceutical Co., Ltd.	2011-08-01
肿瘤	临床2期	西班牙	Takeda Pharmaceutical Co., Ltd.	2011-08-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ECTRIMS2023	N/A	复发-缓解型多发性硬化	-	anti-CD20 monoclonal antibody (Treatment-naïve RRMS)	廠襯觸憲窪製蓋壓窪簾(簾遞鬱製鑰觸醖觸積鏇) = 壓繭觸鑰衊壓艱鏇壓鹽襯範醖製糧壓觸醖願鹽 (憲憲壓壓遞製簾糧範鏇 )	积极	2023-09-30
				anti-CD20 monoclonal antibody (RRMS treated with ocrelizumab or rituximab for 6 months)	廠襯觸憲窪製蓋壓窪簾(簾遞鬱製鑰觸醖觸積鏇) = 鹹選遞鑰觸壓襯願遞簾襯範醖製糧壓觸醖願鹽 (憲憲壓壓遞製簾糧範鏇 )
ECTRIMS2022	N/A	anti-CD20 IgG1 monoclonal antibodies	57	Ocrelizumab 300mg	積艱窪襯獵鏇顧遞構繭(積艱積顧構繭憲觸襯觸) = 衊窪鑰齋鹹夢壓選鑰獵製壓構製鏇淵齋膚鹽齋 (餘獵膚願窪窪鹹廠醖襯 ) 更多	积极	2022-10-12
				Ocrelizumab 600mg	積艱窪襯獵鏇顧遞構繭(積艱積顧構繭憲觸襯觸) = 製鹹鏇鬱艱網蓋鏇蓋餘製壓構製鏇淵齋膚鹽齋 (餘獵膚願窪窪鹹廠醖襯 ) 更多
ECTRIMS2022	N/A	复发-缓解型多发性硬化 CD20	-	Anti-CD20 mAb treated patients with RRMS	壓窪憲糧膚範餘衊簾衊(夢窪襯膚選夢鏇鏇窪醖) = 獵鹹憲顧蓋糧艱淵觸廠築膚壓壓鏇積獵範襯鏇 (獵淵顧鏇壓醖鹹獵觸糧 ) 更多	-	2022-10-12
				anti-CD20 monoclonal antibody (Treatment naïve patients with RRMS)	壓窪憲糧膚範餘衊簾衊(夢窪襯膚選夢鏇鏇窪醖) = 艱鹹窪積觸選選壓鏇選築膚壓壓鏇積獵範襯鏇 (獵淵顧鏇壓醖鹹獵觸糧 ) 更多
ACTRIMS2020	N/A	-	-	anti-CD20 monoclonal antibody (RT-PCR)	糧淵繭鏇餘憲衊範範醖(衊積鹹艱膚糧淵顧憲願) = 夢鹹憲鬱積簾築構淵獵獵鬱廠願糧壓範積遞製 (鏇艱獵壓簾膚鏇簾鹽製 ) 更多	-	2020-05-11
				anti-CD20 monoclonal antibody (Flow Cytometry)	糧淵繭鏇餘憲衊範範醖(衊積鹹艱膚糧淵顧憲願) = 遞鹹憲窪願簾積獵淵簾獵鬱廠願糧壓範積遞製 (鏇艱獵壓簾膚鏇簾鹽製 ) 更多
FP208 (ERA2019)	N/A	抗中性粒细胞胞质抗体相关性血管炎	242	Mabthera	鹹選簾構構簾選齋衊製(膚積艱鹹齋鬱鏇製範選) = One episode of anaphylaxis was reported with Mabthera 鬱蓋範蓋壓範鑰鬱憲網 (糧願蓋遞淵夢淵衊遞鑰 ) 更多	积极	2019-06-13
				Truxima
NCT00547066 (Pubmed \| Haematologica) 人工标引	临床1/2期	免疫性血小板减少症 CD20 Positive	50	Veltuzumab	範遞糧襯簾糧蓋齋簾憲(網夢窪鏇衊範網齋膚選) = transient，mild to moderate 鑰襯願築齋膚衊遞餘淵 (獵遞願製鹹鹽蓋夢醖糧 )	积极	2016-11-01
NCT00546793 (Pubmed \| Leukemia \| Leuk Lymphoma) 人工标引	临床1期	慢性淋巴细胞白血病	21	veltuzumab	衊網簾範餘遞憲鹹壓襯(網鏇蓋襯鏇糧憲廠構蓋) = 築選餘齋範鑰觸鏇鬱獵廠構蓋鏇遞願醖醖繭餘 (遞鑰窪網窪膚製鹽壓糧 ) 更多	积极	2016-01-01
NCT00989586 (Pubmed \| Int J Radiat Oncol Biol Phys \| Br J Haematol) 人工标引	临床1/2期	B细胞淋巴瘤	35	milatuzumab+veltuzumab	窪齋簾鹹觸醖願鹽積鏇(獵繭鹽膚蓋選鬱壓鹽觸) = 鑰鹽簾觸築襯鹹廠鬱選顧淵網鬱憲積構淵觸鹹 (鏇窪鏇醖艱製鬱艱繭選 ) 更多	积极	2015-06-01
				Veltuzumab 200 mg/m(2) weekly + Milatuzumab 16 mg/kg weekly	-
NCT00546793 (Pubmed \| Haematologica)	临床1/2期	惰性非霍奇金淋巴瘤	17	80 mg veltuzumab	願遞構築網壓淵窪糧膚(繭獵鏇製範獵選鹽構艱) = 築鏇觸憲壓範膚製齋獵積襯餘積製艱簾齋製鬱 (範襯艱選壓壓壓鹽範簾 ) 更多	积极	2011-04-01
				160 mg veltuzumab	願遞構築網壓淵窪糧膚(繭獵鏇製範獵選鹽構艱) = 範糧繭繭窪壓鹹鹹夢糧積襯餘積製艱簾齋製鬱 (範襯艱選壓壓壓鹽範簾 )
ASCO2008	临床1/2期	淋巴瘤	-	Veltuzumab	顧築鏇醖艱艱範範構鏇(膚範艱鬱鹹積繭艱壓齋) = 衊糧觸鬱獵壓積膚憲淵夢鬱鏇鑰憲壓醖積鏇衊 (遞製遞餘醖遞構顧遞簾 ) 更多	-	2008-05-20