An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)

Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.

开始日期2025-11-01

申办/合作机构

Stanford University

[+1]

NCT06572605

/ Not yet recruiting临床1/2期IIT

A Phase 1b/2 Study of Talquetamab Plus Concomitant Priming Radiotherapy in Multiple Myeloma With Extramedullary Disease

This phase I/II trial tests the safety and effectiveness of extramedullary disease (EMD)-directed external beam radiation therapy (EBRT) in combination with talquetamab for the treatment of multiple myeloma patients with extramedullary disease. Extramedullary disease in multiple myeloma involves the infiltration of organs and soft tissues by malignant plasma cells and has proven difficult to treat. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink cancers. EBRT is a type of radiation therapy that delivers high-energy beams to the cancer from outside of the body. In this trial, the EBRT will be directed to a site of extramedullary disease. Talquetamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Combining EMD-directed EBRT with talquetamab may be safe, tolerable, and/or effective in treating multiple myeloma patients with extramedullary disease.

开始日期2025-03-01

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06827860

/ Not yet recruiting临床2期IIT

A Phase 2 Single-Arm Study of Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse

Induction therapy approaches in recent years have evolved, now utilizing triple or quadruple drug regimens in the majority of patients. By combining anti-CD38 antibodies, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and steroids, patients achieve longer remissions with their first- and second-line therapies but also become refractory to most or all three major drug classes earlier. For patients who are refractory to at least 3 of the commonly administered PIs and IMiDs, occurring after 2 lines of therapy in many, the median overall survival is only 5 months. Elderly, frail patients are not often candidates at this point for aggressive therapies like stem cell transplantation and CAR T-cell therapy thus necessitating effective yet tolerable treatments for elderly patients in early relapse (1-3 prior therapy). Talquetamab is a GPRC5DxCD3 bispecific antibody that redirects patients' T cells to myeloma cells which express GPRC5D. In the phase 1 MonumenTAL-1, heavily pretreated patients with a median of 6 prior lines of therapy attained a 70% response rate with 405 μg/kg of subcutaneous (SC) talquetamab. Importantly, subcutaneous talquetamab was found to be tolerable for the treated population, which included 28% of patients aged ≥70, with only three patients experiencing dose-limiting toxicities in the form of grade 3 rashes which responded to steroids. The anti-CD38 antibody daratumumab eliminates CD38-positive T and B regulatory cells, potentiates the activity of bispecific antibodies like talquetamab, and may improve its efficacy when used in combination. The aim of this study will be to assess the efficacy and safety of treating elderly patients with relapsed/refractory multiple myeloma with at least ≥2 prior lines of therapy with subcutaneous talquetamab. Patients who have progressive disease on talquetamab or who fail to respond after 3 cycles will have subcutaneous daratumumab added to their regimen.

开始日期2025-02-01

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+1]

100 项与塔奎妥单抗相关的临床结果

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100 项与塔奎妥单抗相关的转化医学

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100 项与塔奎妥单抗相关的专利（医药）

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项与塔奎妥单抗相关的文献（医药）

2025-04-01·ANNALS OF PHARMACOTHERAPY

Targeting GPRC5D With Talquetamab: A New Frontier in Bispecific Antibody Therapy for Relapsed/Refractory Multiple Myeloma

Review

作者: Horton, Daniel ; Shaver, Jacob ; Halford, Zachery

Objective::

To evaluate the pharmacology, clinical efficacy, safety, dosing, administration, and clinical implications of talquetamab-tgvs, a novel bispecific antibody, in the treatment of relapsed or refractory (R/R) multiple myeloma (MM).

Data Sources::

A comprehensive English-language literature search of PubMed and Clinicaltrials.gov from January 2000 to May 2024 was conducted using the terms talquetamab, Talvey, JNJ-64407564, and “Multiple Myeloma.”

Study Selection and Data Extraction::

Relevant clinical trials, guidelines, and prescribing information were systematically reviewed and analyzed.

Data Synthesis::

Talquetamab-tgvs received accelerated approval from the United States Food and Drug Administration based on results from the pivotal phase I/II MonumenTAL-1 clinical trial, which demonstrated an overall response rate of nearly 74% in key cohorts. The median progression-free survival was 7.5 months in the 0.4 mg/kg weekly dosing cohort and 11.9 months in the 0.8 mg/kg biweekly dosing cohort. Treatment-related adverse events (AEs) included cytokine release syndrome, skin- and nail-related AEs, dysgeusia, infections, and immune effector cell-associated neurotoxicity syndrome.

Relevance to Patient Care and Clinical Practice::

As a first-in-class anti-GPRC5D T-cell-redirecting bispecific antibody, talquetamab-tgvs represents a compelling treatment option for patients with R/R MM who have received at least 4 prior lines of therapy. No head-to-head clinical trials have been conducted comparing talquetamab-tgvs to other T-cell-redirecting therapies.

Conclusions::

While talquetamab-tgvs showed significant efficacy in the pivotal MonumenTAL-1 trial, long-term safety and efficacy data are needed. Additional clinical trials are necessary to establish the optimal timing, sequencing, patient population, and overall role of talquetamab-tgvs in the rapidly evolving treatment landscape of R/R MM.

2025-04-01·Clinical Lymphoma Myeloma & Leukemia

Expert Opinion on Multiple Myeloma Treatment in Brazil in the Bispecific Antibody Era

Review

作者: Pericole, Fernando Vieira ; Sanku, Gayatri ; Pinto Neto, Jorge Vaz ; Filho, Roberto Jose Pessoa de Magalhães ; Maiolino, Angelo ; Hungria, Vania ; Garibaldi, Pedro Manoel Marques ; Jansen, Angela Marie

Multiple myeloma treatment has evolved rapidly with the development of novel targeted therapies. The paper outlines multiple myeloma epidemiology, current treatments, and recent advances, highlighting the role of bispecific antibodies. Brazilian authorities have approved 3 bispecific antibodies (teclistamab, elranatamab, and talquetamab) for relapsed/refractory multiple myeloma patients who have received at least three prior therapies. These therapies have shown promising efficacy in clinical trials, with 61%-74% overall response rates. However, access to these treatments varies significantly between Brazil's private and public healthcare systems. A panel of 6 Brazilian experts in multiple myeloma and bispecific antibody therapy convened for a three-day virtual conference organized and moderated by Americas Health Foundation. They addressed key questions regarding bispecific antibody therapy in multiple myeloma and developed consensus recommendations. While bispecific antibodies offer new hope for multiple myeloma patients, challenges remain in ensuring equitable access to these therapies. The paper discusses the sequencing of bispecific antibodies with other treatments, the management of adverse events, and the need for real-world data. It also highlights the disparities in multiple myeloma treatment between Brazil's public and private healthcare systems, emphasizing the need for targeted efforts to bridge this gap and improve outcomes for all multiple myeloma patients.

2025-03-01·EUROPEAN JOURNAL OF HAEMATOLOGY

Talquetamab in Multiple Myeloma: Efficacy, Safety, and Future Directions

Review

作者: Gentile, Massimo ; Vigna, Ernesto ; Puccio, Noemi ; Labanca, Caterina ; Martino, Enrica Antonia ; Bruzzese, Antonella ; Lucia, Eugenio ; Neri, Antonino ; Mendicino, Francesco ; Olivito, Virginia ; Morabito, Fortunato

ABSTRACT:

Relapsed and refractory multiple myeloma (RRMM) remains a challenging condition despite advances in immunotherapies. Novel bispecific antibodies (BsAbs), including talquetamab, have shown promising efficacy in heavily pretreated patients, even those with triple‐ and penta‐refractory disease. Talquetamab, recently approved by the FDA and EMA, is indicated for patients who have progressed after at least three or four prior lines of therapy (LOTs). Administered following a step‐up dosing phase to manage cytokine release syndrome (CRS), talquetamab demonstrated a high overall response rate (ORR) of approximately 70%, including in patients previously treated with T‐cell redirecting therapies. Its safety profile is consistent with other BsAbs, with hematologic adverse events such as anemia and neutropenia commonly reported, alongside unique on‐target off‐tumor toxicities like dysgeusia and skin‐related events. Infections were less frequent compared to other BsAbs. The optimal sequencing of talquetamab and other therapies, including CAR‐T cell treatments, remains an area of active research, as resistance to anti‐BCMA therapies presents ongoing clinical challenges. Current trials are exploring the use of talquetamab in combination therapies, as well as therapeutic strategies post‐treating progression. The real‐world data further support talquetamab's efficacy, making it a valuable addition to the RRMM treatment landscape.

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项与塔奎妥单抗相关的新闻（医药）

2025-03-24

·PRNewswire

CARVYKTI Continued Performance Reflects Growing Confidence in CAR-T Therapies for Multiple Myeloma | DelveInsight

As a BCMA-targeting CAR T-cell therapy, CARVYKTI addresses a high unmet need in relapsed or refractory multiple myeloma patients. With promising clinical efficacy, durable responses, and growing adoption in advanced treatment lines, CARVYKTI is poised for substantial revenue growth. LAS VEGAS, March 24, 2025 /PRNewswire/ -- DelveInsight's " CARVYKTI Market Size, Forecast, and Market Insight Report" highlights the details around CARVYKTI, a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's T cells with a transgene encoding a CAR that identifies and eliminates cells that express BCMA. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of CARVYKTI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Janssen's CARVYKTI (ciltacabtagene autoleucel) Overview CARVYKTI is an autologous T-cell immunotherapy that targets B-cell maturation antigen (BCMA). It works by genetically modifying a patient's T cells with a transgene that encodes a chimeric antigen receptor (CAR). This CAR helps the T cells recognize and destroy cells expressing BCMA, which is primarily found in malignant multiple myeloma B-lineage cells, late-stage B cells, and plasma cells. The CARVYKTI CAR protein includes two single-domain antibodies designed to bind strongly to human BCMA, enhancing T-cell activation, proliferation, and the destruction of target cells upon binding. Currently, CAR-T cell therapies are only available to UK patients through clinical trials. Janssen recently decided not to proceed with seeking approval for cilta-cel (CARVYKTI) for myeloma patients in the UK through the National Institute for Health and Care Excellence (NICE). This decision means cilta-cel will not be available on the NHS for now, although it remains accessible through clinical trials. Janssen's decision does not impact ongoing trials. The drug is currently being evaluated in Phase III trials: CARTITUDE-6 for frontline multiple myeloma transplant eligible vs ASCT and CARTITUDE-5 for frontline multiple myeloma TNI. In 2024, CARVYKTI generated sales of USD 963 million across the world. CARVYKTI Dosage and Administration CARVYKTI is administered as a single infusion containing a suspension of CAR-positive, viable T cells in one infusion bag. The recommended dosage ranges from 0.5 to 1.0 × 10⁶ CAR-positive viable T cells per kilogram of body weight, with a maximum limit of 1 × 10⁸ CAR-positive viable T cells per infusion. Learn more about CARVYKTI projected market size for multiple myeloma @ CARVYKTI Market Potential CAR-T cell immunotherapy is emerging as a revolutionary treatment for multiple myeloma, offering new hope to patients who have exhausted conventional treatment options. Currently, only two CAR-T cell therapies are approved for multiple myeloma: ABECMA (idecabtagene vicleucel) from Bristol-Myers Squibb and CARVYKTI (ciltacabtagene autoleucel) from Johnson & Johnson Innovative Medicine. Their approval highlights the potential of CAR-T therapy to transform multiple myeloma treatment. A key advantage of CAR-T therapies is their "one-and-done" nature, requiring a single administration, unlike bispecific antibodies such as TECVAYLI and TALVEY, which need ongoing dosing. Present CAR-T therapies use a patient's own T cells (autologous), but research is underway to develop allogeneic CAR-T cells derived from healthy donors. Allogeneic therapies could offer off-the-shelf solutions, enhancing accessibility and lowering costs. The approval of CAR-T therapies has created new opportunities for companies focused on advanced-stage multiple myeloma (fourth line and beyond). Several companies are progressing with their CAR-T candidates at different stages of development. The CAR-T cell therapy market for multiple myeloma is expected to grow significantly between 2024 and 2034, driven by its high efficacy and potential for expanded use. Collaboration between pharmaceutical companies and research institutions, along with ongoing innovation, is expected to accelerate market growth. However, challenges such as manufacturing complexity and pricing will need to be addressed to unlock the full potential of CAR-T therapies. Discover more about the CAR T-cell therapy for multiple myeloma market in detail @ CAR T-cell Therapy for Multiple Myeloma Market Report Emerging Competitors of CARVYKTI Some of the CAR-Ts in the multiple myeloma pipeline that will give fierce competition to CARVYKTI include Anito-cel (Arcellx), PHE885 (Novartis), BMS-986393 (Bristol-Myers Squibb), Zevorcabtagene Autoleucel (CARsgen Therapeutics), and GLPG5301 (Galapagos), among others In December 2024, Arcellx announced encouraging new data from its Phase II pivotal iMMagine-1 trial for anito-cel in multiple myeloma. The results were presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting on Monday, December 9, 2024, at 5:30 p.m. PT. Also at ASH 2024, BMS shared the first overall survival (OS) and progression-free survival (PFS) results for arlo-cel in an oral presentation. The Phase I trial involved patients with relapsed or refractory multiple myeloma who had previously undergone at least three treatments, including a proteasome inhibitor, an immunomodulatory drug, and anti-CD38 therapy. Among 79 patients evaluable for efficacy, with a median follow-up of 16.1 months (range: 2.8–25.2), arlo-cel showed an overall response rate (ORR) of 87%, indicating durable responses. Minimal residual disease (MRD) was assessed as an exploratory measure, with 57% (48 of 84) of MRD-evaluable patients included. Of these, 46% (22 of 48) were MRD-negative and achieved a complete response (CR) or stringent CR (sCR). Across all treated patients, 27% (23 of 84) were MRD-negative and achieved a CR. Median PFS was 18.3 months (95% CI: 11.8–21.9), while the median OS had not yet been reached. To know more about the number of competing drugs in development, visit @ CARVYKTI Market Positioning Compared to Other Drugs Key Milestones of CARVYKTI In April 2024, Johnson & Johnson announced that the US FDA approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. In March 2024, Johnson & Johnson announced that the US FDA Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. In February 2024, Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the approval of a Type II variation for CARVYKTI for the earlier treatment of RRMM. In September 2022, Legend Biotech announced that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions including patients having no history of CAR-positive T-cell infusion therapy targeting BCMA and patients who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. In May 2022, Janssen announced that the European Commission (EC) granted conditional marketing authorization for CARVYKTI for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. In February 2022, Janssen announced that the US FDA had approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In August 2020, Legend Biotech announced that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) had recommended BTD for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells) for the treatment of adults with relapsed or refractory multiple myeloma. In December 2019, Janssen announced receipt of a BTD from the US FDA for cilta-cel. In April 2019, the EMA granted a PRIME (PRIority MEdicines) designation for the company's investigational BCMA CAR-T therapy. In February 2019, the US FDA granted ODD for cilta-cel (JNJ-4528), and in February 2020, the European Commission also granted orphan designation for this drug. In December 2017, Janssen entered a worldwide collaboration and license agreement with Legend Biotech to jointly develop and commercialize LCAR-B38M in multiple myeloma Discover how CARVYKTI is shaping the multiple myeloma treatment landscape @ CARVYKTI CAR-T CARVYKTI Market Dynamics The market for CARVYKTI is driven by the increasing prevalence of multiple myeloma and the growing demand for innovative therapies that can address the limitations of existing treatments, such as proteasome inhibitors and immunomodulatory drugs. The competitive landscape includes other BCMA-targeting therapies, such as Bristol Myers Squibb's ABECMA (idecabtagene vicleucel), which was the first BCMA-directed CAR-T therapy approved for multiple myeloma. CARVYKTI's strong clinical efficacy, coupled with its potential for long-term remission, gives it a competitive edge, but challenges related to manufacturing scalability, logistical complexities, and high treatment costs could impact its market penetration and patient accessibility. Strategic partnerships and ongoing clinical development will play a key role in expanding CARVYKTI's market reach. Janssen and Legend Biotech are actively working to improve manufacturing processes to reduce vein-to-vein time and address supply chain bottlenecks. Furthermore, ongoing trials, such as CARTITUDE-4, are exploring CARVYKTI's use in earlier lines of therapy, which could significantly expand its patient base and market potential. If successful in earlier settings, CARVYKTI could shift the treatment paradigm for multiple myeloma and increase adoption among physicians and healthcare providers. Despite its promising clinical profile, CARVYKTI faces challenges related to reimbursement and healthcare infrastructure. The high cost of CAR-T therapies often limits patient access, particularly in markets with strict reimbursement policies. Moreover, the complex nature of CAR-T administration, which requires specialized centers and trained personnel, adds to the barriers. However, continued clinical success, regulatory support, and improvements in manufacturing and delivery infrastructure could strengthen CARVYKTI's market position and establish it as a cornerstone therapy in the multiple myeloma treatment landscape. Dive deeper to get more insight into CARVYKTI's strengths & weaknesses relative to competitors @ CARVYKTI Market Drug Report Table of Contents Related Reports Relapsing Refractory Multiple Myeloma Market Relapsing Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key RRMM companies including AbbVie, Genentech, Amgen, Onyx Therapeutics Inc., Bristol-Myers Squibb, MedImmune LLC, Novartis Pharmaceuticals, Incyte Corporation, Takeda, among others. Relapsing Refractory Multiple Myeloma Pipeline Relapsing Refractory Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMM companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies including Sanofi, Karyopharm Therapeutics, AbbVie, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including CASI Pharmaceuticals, Carsgen Therapeutics, Cartesian Therapeutics, Gracell Biotechnology Shanghai Co., Ltd., Sorrento Therapeutics, TeneoOne, Karyopharma Therapeutics, Arcellx, Poseida Therapeutics, Ichnos Sciences, Nerviano Medical Sciences, Bristol Myers Squib, Ascentage Pharma, Ionis Pharmaceuticals, Chongqing Precision Biotech Co., Ltd., CRISPR Therapeutics, AstraZeneca, IGM Biosciences, Novartis, GlaxoSmithKline, Innovent Biologics, Keymed Biociences, Starton Therapeutics, Takeda, Fate Therapeutics, Gilead Sciences, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., Janssen Pharmaceutical, Nanjing IASO Biotechnology Co., Ltd., GPCR Therapeutics, Chimerix, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果免疫疗法孤儿药上市批准临床3期

2025-03-19

·抗体圈

盘点：2024年全球十大畅销药物

近日，BioSpace盘点了2024年销售额最高的10大医药产品。这份名单中既有热门品种如诺和诺德的Ozempic，也有几种面临专利悬崖却设法保持了其市场主导地位的产品，如艾伯维的Humira，以下为这10款药物的简要介绍。 01 帕博利珠单抗药物名称：Keytruda 公司名称：默沙东 2024年销售额：294.8亿美元同比变化：+18% 默沙东的重磅PD-1抑制剂Keytruda连续第二年位居制药公司最畅销产品榜首。2024年，Keytruda同比增长18%，销售额达到294.8亿美元。鉴于Keytruda已成为拥有40多种癌症适应症的疗法，包括各种形式的肺癌和妇科癌症等，因此这一销售额并不令人惊讶。2024年9月，FDA批准Keytruda用于胸膜间皮瘤的一线治疗，根据2024年8月的一份IMARC报告，这一市场到2034年的价值可能超过120亿美元。但Keytruda的关键专利将于2028年到期，这将使其面临生物类似药竞争，进而瓜分销售额。监管部门对Keytruda的广泛使用以及更广泛的PD-1抑制剂的担忧似乎也越来越严重。2024年9月，FDA咨询小组以压倒性多数投票决定缩小Keytruda以及百时美施贵宝的Opdivo和Yervoy在胃癌和食管癌中的标签，限制它们在PD-1表达水平低的患者中的使用。但FDA尚未发布正式指令。默沙东正在尽其所能保持Keytruda的市场主导地位。默沙东公司正在准备开发Keytruda的皮下制剂。2024年11月，默沙东宣布了PD-1抗体Keytruda皮下给药制剂关键的3期MK-3475A-D77试验的阳性顶线结果。如果开发成功，该产品的推出有望延续产品生命周期。 02 司美格鲁肽（Ozempic）药物名称：Ozempic 公司名称：诺和诺德 2024年销售额：169亿美元同比变化：+26% 广受欢迎的2型糖尿病药物Ozempic是2024年表现最好的药物之一。诺和诺德在其全年业务报告中透露，GLP-1疗法去年的收入超过1200亿丹麦克朗，约合169亿美元。相对于2023年，Ozempic的销售额增长了26%——并且有望在未来几年看到更大的上升趋势。Ozempic最初于2017年获得批准以改善血糖控制，并于2020年获得额外批准以降低心血管风险，并于2025年1月获得额外批准以降低患慢性肾病的新适应证。然而，阻碍Ozempic增长的是《通货膨胀削减法案》（IRA）。今年早些时候，美国医疗保险和医疗补助服务中心（CMS）选择了GLP-1药物Ozempic以及Rybelsus（口服司美格鲁肽）进行第二轮药品价格谈判。在过去的一年里，诺和诺德收到了几次电话，要求降低Ozempic的标价。面对Ozempic价格上限的前景，诺和诺德已要求美国第三巡回上诉法院加快其对IRA的持续投诉的诉讼程序，诺和诺德声称价格谈判侵犯了其宪法权利。然而，这一论点迄今未能说服法官。 03 比克恩丙诺药物名称：Biktarvy 公司名称：吉利德 2024年销售额：134亿美元同比变化：+13% 吉利德的抗逆转录病毒药物Biktarvy扩大了HIV市场的规模，该药物在2024年增长了13%，带来了134.2亿美元的销售额，该制药公司将这一增长归因于对该药物的“更高需求”。 Biktarvy目前是吉利德HIV业务的基石。它占据了美国HIV市场50%以上的份额，与Keytruda和Ozempic不同，Biktarvy在不久的将来没有明显的阻力。该药物的关键专利保护将在未来几年保持不变，并将在2033年之前使仿制药竞争对手无法进入市场。同时，Biktarvy也不在美国医保与医助服务中心的第二轮药品谈判名单之列。 04 阿哌沙班药物名称：Eliquis 公司名称：BMS，辉瑞 2024年销售额：133亿美元同比变化：+9% 血液稀释剂Eliquis通过百时美施贵宝和辉瑞之间的紧密合作，在2024年实现了133亿美元的收入，销售额同比增长9%。长期以来，这种药物一直是两家公司的宝贵资产，但这可能很快就会结束。Eliquis将在2026年失去市场独占权——几种仿制药已经排队等候，渴望进入美国市场并蚕食该药物的收益。其中包括来自Mylan Pharmaceuticals和Micro Labs Limited的仿制药产品，FDA于2019年12月初批准了这些产品。 Eliquis也是去年进行CMS药品价格谈判的第一批药物之一，价格为231美元，定于2026年生效，比原始标价低56%。为了应对Eliquis可能造成的收入损失，BMS启动了一项数十亿美元的节流计划，目标是到2025年底削减15亿美元的成本，到2027年再削减20亿美元的成本。辉瑞正在采取类似的方法，在2024年设定了35亿美元的节流目标，并在2027年底之前再实现减少15亿美元成本的目标。 05 度普利尤单抗药物名称：Dupixent 公司名称：Sanofi、Regeneron 2024年销售额：130亿美元同比变化：+23% 赛诺菲和再生元正在联合将免疫学重量级产品Dupixent商业化，特应性皮炎、哮喘该公司去年的收入为130.72亿美元，同比增长23%。与Biktarvy一样，Dupixent似乎没有与专利和IRA相关的问题。该药物将在2031年之前保持市场独占权。FDA于2024年9月批准Dupixent用于治疗慢性阻塞性肺病，预计将于今年推出。此前，Dupixent已被批准用于特应性皮炎、哮喘。因此，该产品前景光明。 06 利生奇珠单抗药物名称：Skyrizi 公司名称：艾伯维 2024年销售额：117亿美元同比变化：+50.9% 艾伯维（AbbVie）抗IL-23疗法Skyrizi，是这份名单上增长最快的资产。Skyrizi的销售额同比增长50.9%，到2024年为公司赚取了117.18亿美元。修美乐（Humira）多年来一直是世界上最畅销的药物。2024年第三季度，尽管Humira的销售额持续下降，但Skyrizi以及JAK抑制剂Rinvoq的销售额帮助AbbVie以微弱优势超过分析师的预期。这一趋势一直持续到第四季度。在2月的一份报告中，针对该制药公司的全年业务报告，分析师表示，Skyrizi和Rinvoq将为艾伯维“迎来一个新的增长时代”，艾伯维终于完全摆脱了Humira的依赖。 Skyrizi市场独占性将持续到2031年。 7/8 达雷妥尤单抗&乌司奴单抗药物名称：Darzalex、Stelara 公司名称：强生 Darzalex 2024年销售额：117亿美元同比变化：+20% Stelara 2024年销售额：103亿美元同比变化：-4.6% 强生在2024年有两款最畅销的药物：一款是Darzalex（达雷妥尤单抗），另一款是Stelara（乌司奴单抗）。 Stelara是一种用于各种炎症性疾病的抗IL-12和IL-23抗体，于2023年9月失去了关键专利保护。此后，其生物类似药进入了美国市场，虽然尚未完全取代Stelara，但已经侵蚀了其市场份额。2023年，该生物制剂的收入为108.6亿美元。去年，销售额下降4.6%至103.4亿美元。为了弥补收入损失，强生公司正在依靠其癌症药物Darzalex，这是一种被批准用于多发性骨髓瘤的抗CD38溶细胞抗体。2024年，Darzalex带来了116.7亿美元的收入，同比增长近20%。根据相关报告，Darzalex将帮助推动强生的癌症治疗药物（包括其CART疗法Carvykti以及双特异性抗体Tecvayli和Talvey）复合年增长率达到15.3%，到2029年销售额达到271亿美元。强生继续致力于扩大Darzalex的标签，包括2024年9月向FDA提交申请，允许该药物用于不符合干细胞移植条件的新诊断多发性骨髓瘤患者，以及2024年11月提交高危冒烟多发性骨髓瘤申请。Darzalex将保护关键专利保护到2029年。 09 阿达木单抗药物名称：Humira 公司名称：艾伯维 2024年销售额：90亿美元同比变化：-37.6% Humira的销售额同比下降37.6%，现在显然已经过了其巅峰时期。2024年，这款曾经占主导地位的抗炎疗法为艾伯维带来了89.93亿美元的收入。修美乐失宠的罪魁祸首显然是日益激烈的生物类似药竞争。自从该药物在2023年失去关键专利保护以来，一些仿制产品进入市场，包括安进的Amjevita、Celltrion的Yuflyma、Cordavis和Sandoz的Hyrimoz以及勃林格殷格翰的Cyltezo。修美乐市场侵蚀的另一个主要驱动因素是CVS Caremark（美国最大药品零售商）于2024年4月将该品牌药物从其主要国家处方集中删除，转而支持生物类似药，包括其Cordavis阿达木单抗品牌Hyrimoz。Cordavis是CVS Caremark的子公司，于2023年8月成立。不过，在2025年第一季度版的三星BioEPIS生物类似药市场动态报告中，Humira仍然是最大的阿达木单抗品牌，控制着72%的市场。在同一报告的2024年第三季度版本中，Humira拥有82%的市场份额。 10 Gardasil 药物名称：Gardasil 公司名称：默沙东 2024年销售额：86亿美元同比变化：-3% 这份名单上唯一的疫苗——默沙东的人瘤病毒疫苗Gardasil在2024年的销售额下降了3%，共创造了85.8亿美元的收入。 Gardasil关键专利保护将于2028年到期，尽管没有生物类似药的出现，疫苗的前景看起来并不乐观。随着著名的疫苗批评者小罗伯特·肯尼迪（Robert F. Kennedy Jr.）担任卫生与公众服务部长。对默沙东和Gardasil来说，更重要的是关注美国卫生当局将如何处理疫苗的问题。此外，Gardasil最近在中国被批准用于男性。2月默沙东公司宣布，由于中国疫苗库存居高不下，将暂停向中国运送Gardasil。参考资料： 1.https://www.biospace.com/business/10-best-selling-drugs-of-2024-rake-in-billions-amid-exclusivity-threats *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

专利到期专利侵权生物类似药临床3期

2025-03-05

·今日头条

抗癌月报（2月）|上市新药，CAR-T，癌症疫苗等新技术进展汇总

在生命与病魔的漫长拔河中，抗癌之路仿若暗夜行舟，每一次新突破都似远方亮起的航标。踏入 2 月，抗癌领域再次迎来诸多令人瞩目的进展，宛如熠熠星辰照亮前行方向。新药的上市为患者开启全新希望之门，CAR - T 技术持续革新，在精准打击癌细胞的征程中迈出坚实步伐，癌症疫苗的研发也不断传来佳音，为人类抵御癌症构筑更坚固防线。此刻，让我们一同深入本月抗癌月报，探寻那些改变命运的关键力量，见证生命在与癌症顽强抗争中的不屈奇迹。抗癌新药月报（2025.2）塔奎妥单抗在华重磅获批，超60%复发性或难治性骨髓瘤患者迎来转机塔奎妥单抗（Talquetamab）是一种First-in-Class双特异性抗体和人源化单克隆抗体，同时也是一种CD3E调节剂，2025年2月11日，在我国获批用于成人复发或难治性多发性骨髓瘤的治疗。早在2023年8月9日，该药就已获得美国食品药品监督管理局（FDA）的加速批准，用于成人既往已接受过至少4种治疗（包括免疫调节剂、CD38单克隆抗体、蛋白酶体抑制剂抗）的复发性或难治性多发性骨髓瘤的治疗。埃万妥单抗：全球首款EGFR/cMET双抗在我国获批，73%客观缓解率完胜非小细胞肺癌单纯化疗埃万妥单抗（Amivantamab，Rybrevant，代号JNJ6372）是由强生旗下的杨森制药研发的一款EGFR间充质-上皮转化因子（c-Met/EGFR）双特异性抗体，具有免疫细胞导向活性，可以%绕过EGFR外显子 20 插入的 NSCLC 患者对酪氨酸激酶抑制剂的配体位点耐药性，将 MET 作为旁路耐药机制，并募集效应细胞发挥抗癌作用。本次在我国获批，用于EGFR 20ins突变的局部晚期或转移性非小细胞肺癌的一线治疗！此前该药的静脉注射剂型已在欧美、日本等国获批上市，埃万妥单抗也成为了全球首个获批的c-Met/EGFR双抗类药物！抗癌新药招募（2025.2）肺癌药品名称： JMT-101 作用靶点： EGFR20 ins 研发公司：津曼特药物介绍： JMT101为人源化抗EGFR单克隆抗体，具有自主知识产权，该产品相较于国内外已上市同类产品西妥昔单抗、帕尼单抗等具有亲和力更高、免疫原性低、药效更优的特点。该产品已于2016年5月获得CFDA临床批件，现已进入I期临床研究，拟用于治疗非小细胞肺癌，结直肠癌等实体瘤。疾病控制率100%，我国自主研发广谱新药重磅登场！临床招募进行中适应症：一线或二线治疗EGFR突变20ins阳性肺癌招募信息（部分）： ⅢB或Ⅳ期非小细胞肺癌，不适合进行根治性手术或放疗，且证实具有EGFR 20号外显子插入突变（包括重复突变），初治或一线治疗失败后的患者。药品名称： ICP-723 作用靶点： ROS1突变研发公司：诺诚建华药物介绍： ICP-723是一种国内研发的第二代泛酪氨酸受体激酶（泛TRK）小分子抑制剂，用于治疗不同肿瘤类型的神经营养性酪氨酸激酶（NTRK）阳性的肿瘤患者以及由于抗性TRK基因突变而对第一代酪氨酸激酶（TRK）抑制剂产生耐药性的患者。2021年8 月 31 日，获得美国食品药品监督管理局（FDA）的研究性新药批准在美国开始 I 期临床试验。适应症： 1.ROS1阳性非小细胞肺癌； 2.克唑替尼或化疗后进展。药品名称： HL-085胶囊联合维莫非尼作用靶点： BRAF V600E 研发公司：科州生物适应症：BRAF V600E 阳性肺癌药物介绍：科露平（妥拉美替尼/HL-085）是我国自主研发的首款高选择性的MEK抑制剂，2024年3月获批上市，成为全球首个且唯一获批针对NRAS突变晚期黑色素瘤适应症的MEK抑制剂，可与RAS-RAF-MEK-ERK信号通路中的MEK1/2结合，阻断下游信号通路的传导，从而抑制肿瘤的生长。招募信息（部分）： 1.经病理组织学/细胞学确认的手术无法切除，局部晚期或转移性的 IIIb、IIIc、IV 期 NSCLC； 2.未经系统治疗或经过系统治疗的人群均可纳入； 3.基线时能够提供 BRAF V600E 突变的基因检测报告胃癌试验药组LM302注射液药物介绍CLDN18.2ADCC单克隆抗体适合患者无法手术切除初治胃癌，需要CLDN18.2 表达阳性。HER-2 阴性的胃和胃食管结合部腺。试验药组TQB2103药物介绍Claudin 18.2ADC适合患者标准治疗后不耐受或进展，需要CLDN18.2 表达检测。HER-2 阴性的胃和胃食管结合部腺癌试验药组SYSA1801药物介绍Claudin 18.2ADC适合患者无法手术切除初治胃癌，需要CLDN18.2 表达检测。胰腺癌【项目名称】：一项在KRAS 突变的晚期胰腺癌患者中评估编码KRAS 新抗原的mRNA 纳米颗粒（ABO2102）安全性、耐受性、免疫原性特征及初步有效性的临床研究【入排信息（部分）】： 1、年龄≥18 岁； 2、经组织病理学和/或细胞学确诊的晚期胰腺导管腺癌，患者为至少经一线系统性治疗后疾病进展或无法耐受相关治疗者，或研究者评估认为不适合化疗，或因其他原因拒绝化疗者。具备研究者认可的基因检测报告，显示携带 KRAS G12A、G12C、G12D、 G12V 或 G13D 任一基因突变既往接受过 KRAS 肿瘤疫苗治疗。其他热招新药【项目名称】评价Vx-001在晚期实体瘤/非小细胞肺癌患者中的安全性、免疫原性和临床抗肿瘤效果的剂量递增和扩展临床研究。【入排信息（部分）】： 1.经组织学和/或细胞学明确诊断为局部晚期或复发、转移性非小细胞肺癌患者，既往PD-1/PD-L1 治疗失败或不适合 PD-1/PD.L1治疗，且接受过完整含铂类化疗治疗(4~6 个疗程)后，无疾病进展； 2.18 周岁≤年龄≤75 周岁，性别不限； 3.患者 HLA 抗原检测必须含有 HLAA*0201型(多肽呈递的基序仅与该 HLA 分子匹配)TERT 表达阳性且肿瘤浸润淋巴细胞(CD3/CD8 TILS)表达为阴性4)根据实体瘤疗效评价标准(RECISTv1.1)，具有至少一个可测量病灶。【项目名称】实体瘤疫苗-ABO2011 【入排信息（部分）】 1、受试者必须为18岁及以上。 2、经病理组织学或细胞学证实的进展或转移的晚期实体瘤。 3、既往接受过系统性标准治疗后疾病进展或不可耐受毒性(不可耐受毒性定义:>IV级的血液学毒性;或>亚级的非血液学毒性:或>工级的心、肝、肾等主要脏器的损害)，且缺乏有效治疗方案的晚期实体瘤。抗癌新技术进展（2025.2）全球首款实体瘤CAR-T纳入突破性治疗品种，即将申报上市近日，全球首款Claudin18.2 CAR-T舒瑞基奥仑赛注射液再次传来喜讯：中国国家药监局药品审评中心（CDE）官网最新公示-CT041自体CAR T细胞注射液纳入突破性治疗品种，适应症为既往接受过至少二线治疗失败的Claudin18.2（CLDN18.2）表达阳性的晚期胃/食管胃结合部（G/GEJ）腺癌。更好的消息是，这款CAR-T预计将于2025年上半年向国家药品监督管理局（NMPA）提交上市申请！这意味着，如果一切顺利，舒瑞基奥仑赛注射液（satri-cel）将成为全球首个上市的实体瘤CAR-T产品，造福中国及全球胃癌患者！原文链接：喜讯！国研Claudin18.2 CAR-T疗法斩获药监局突破性疗法认定，96.1%疾病控制率创奇迹惊爆！益生菌疗法让转移性结直肠癌1年生存率突破89%！肠道健康显著提升近期全球知名《BMC胃肠病学》杂志报道的一项新研究表明，益生菌与免疫检查点抑制剂、化疗联合使用，能显著改善转移性结直肠癌（mCRC）患者的消化健康、免疫反应及总体预后！该研究还指出，益生菌疗法可作为癌症治疗策略的重要补充，有助于提高患者生存率，减少治疗相关并发症。治疗6个月生存率分别为97.92%（益生菌干预组，47例） vs 93.75%（对照组，45例）。治疗1年生存率分别为89.58%（益生菌干预组，43例） vs 83.33%（对照组，40例）。治疗2年生存率分别为83.33%（益生菌干预组，40例） vs 75.00%（对照组，36例）。显然，在为期两年的随访期内，益生菌组患者在治疗6个月、1年和2年后生存率，均高于对照组患者。原文链接：惊爆！益生菌疗法让转移性结直肠癌1年生存率突破89%，肠道健康显著提升 CAR-NK联合疗法喜获FDA认定！ 2025年2月27日，据生物医药媒体BioSpace报道，ImmunityBio公司宣布其CAR-NK（PD-L1 t-haNK）细胞疗法与IL-15超激动剂ANKTIVA®联合方案，获美国FDA授予“再生医学先进疗法”（RMAT）认定，用于逆转接受标准化疗/放疗后出现淋巴细胞减少症的多次复发局部晚期或转移性胰腺癌患者。值得一提的是，这是CAR-NK细胞疗法在经历了长时间的沉寂后，再度传来的令人振奋的消息！原文链接：CAR-NK联合疗法喜获FDA认定！细数全球四大CAR-NK抗癌攻坚成果，力破肠癌、淋巴瘤、白血病等 2年生存率超80%！《Nature》子刊曝树突状细胞疫苗Ⅲ期临床数据近期，全球知名期刊《自然・通讯（Nature Communications）》公布了一项“自体天然树突状细胞（nDC），治疗IIIB/C期黑色素瘤的III期临床试验（NCT02993315）”的重磅数据。研究表明，采用自体天然树突状细胞（nDC）治疗，能够诱导癌症患者产生肿瘤特异性免疫反应和临床反应，这无疑为黑色素瘤患者带来了新的曙光！本次公开的这项III期临床试验（NCT02993315），共入组148例已切除的 IIIB/C 期黑色素瘤患者，将其随访分为两组，即自体天然树突状细胞治疗组（nDC，n=99）、对照组（n=49）。数据截止时，中位随访时间为 56.3 个月。结果显示： nDC治疗组的中位无复发生存期（RFS）为12.7个月（90% CI，7.7−17.7），2年无复发生存（RFS）率为36.8%（90% CI，29.6−45.7%）。nDC治疗组的2年总生存（OS）率为84.7%（90% CI 78.9−90.9%）。《Nature》重磅！mRNA癌症疫苗持续有效长达7.7年！有望根除微转移，预防复发癌症患者迎来福音！2月19日，国际重磅期刊《Nature》上刊登了一款可用于实体肿瘤的mRNA 新抗原疫苗最新研究成果，引起巨大轰动！在应答者中，自基因 cevumeran 诱导的 CD8 + T 细胞克隆平均估计寿命为 7.7 年（范围为 1.5 至约 100 年），其中约 20% 的克隆具有数十年的潜伏寿命，可能比宿主存活时间更长，这意味着这款新型的癌症疫苗可以帮助延缓或防止癌症复发！原文链接：《Nature》重磅！mRNA癌症疫苗持续有效长达7.7年！有望根除微转移，预防复发 100%患者完全缓解超1年！新型γ-δT细胞疗法INB-100首阶段成果优异 2024年6月13日，“IN8bio”官网公示的信息显示，该公司研发的创新型γ-δT细胞疗法——INB-100，在2024年欧洲血液学协会（EHA）混合大会上，公布了第1阶段试验的最新数据。结果令人振奋：100%接受治疗的白血病患者（n=10/10）在1年时，达到持久的完全缓解（CR），其中还讲述了此前历经多种疗法（包括CAR-T）均宣告失败的高危和致命性急性细胞白血病（AML）患者。这一成果，无疑为癌症患者带来了全新的曙光与希望！原文链接：新型γ-δT细胞疗法INB-100首阶段成果惊人，100%患者完全缓解超1年 CAR-T创造19年无癌生存奇迹，强势打破实体瘤缓解记录近日，全球知名期刊《Nature》的头版，给整个医疗界带来了一个重磅惊喜。其报道称，一位神经母细胞瘤患儿在接受CAR-T细胞治疗后，已持续处于缓解状态超18年（将近19年），并且这期间不需要额外治疗。据悉，这是目前所有接受CAR-T细胞疗法的患者中，持续时间最长的完全缓解病例，该研究成果同时也在《NatureMedicine（自然医学）》杂志上发表。原文链接：《Nature》头版惊爆：CAR-T创造19年无癌生存奇迹，强势打破实体瘤缓解记录 64%胰腺癌实现2年无复发！树突细胞治疗打破“癌王”死亡魔咒近期，发表在美国《临床肿瘤学》杂志上的一项新研究带来了令人振奋的消息：树突细胞疗法展现出显著成效，为胰腺癌患者点亮了新的希望之光！在相关试验中，接受树突细胞疗法的患者 2 年无复发生存率达 64% ，2 年总生存率更是高达 83% ！这一成果无疑给笼罩在黑暗中的患者带来了新的曙光。64%胰腺癌实现2年无复发！树突细胞治疗打破“癌王”死亡魔咒 100%患者3年未复发！个体化癌症疫苗有望将“绝症”变为“慢性病” 近期，国际重磅期刊《Nature》上发表的一篇文章引起巨大轰动，各大媒体争相报道这一爆炸性新闻：100% 患者在术后注射癌症疫苗后长达3年未复发，最长无癌生存达到 4年！个体化新抗原疫苗（PCV）取得震撼突破，有望打破癌症“死亡魔咒”，开启将“绝症”转为“慢性病”的新纪元！总生存期超33个月！北京启动KRAS特异性TCR-T细胞临床研究！近日，国家卫生健康委员会批准了首都医科大学附属北京地坛医院（以下简称“北京地坛医院”）体细胞临床研究机构与临床研究项目的备案。随后，“ KRAS特异性自体TCR-T细胞注射液临床研究 ”项目启动会顺利召开。这一系列进展，标志着我国在细胞治疗临床研究领域实现了历史性突破。想寻求癌症疫苗，TCR-T疗法及其他国内外新抗癌治疗帮助，且经济条件允许的情况下，可以先将病历提交至全球肿瘤医生网医学部进行初步评估，一旦审核通过，有机会获得”天价“疗法免费治疗的机会。过去十年，肿瘤的治疗已经取得了长足的进展，逆转了晚期患者的生存期，除了上面整理的内容，还有更多的新药正在研发中，更多的病友可以通过新药获得更长的生存期。让我们拭目以待，期待更多新药早日上市，造福大众！也期待2025，病友们能够打败癌症，活过一个又一个10年！本文为全球肿瘤医生网原创，未经授权严禁转载

免疫疗法上市批准细胞疗法加速审批疫苗

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适应症	国家/地区	公司	日期
多发性骨髓瘤	美国	Janssen Biotech, Inc.	2023-08-09

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适应症	最高研发状态	国家/地区	公司	日期
难治性多发性骨髓瘤	临床3期	美国	Janssen Research & Development LLC	2022-10-20
难治性多发性骨髓瘤	临床3期	波兰	Janssen Research & Development LLC	2022-10-20
外周干细胞移植	临床2期	美国	Janssen Scientific Affairs LLC	2025-11-01
阴燃多发性骨髓瘤	临床2期	美国	Janssen Scientific Affairs LLC	2023-12-04
复发性多发性骨髓瘤	临床2期	加拿大	Janssen Research & Development LLC	2020-12-15
血液肿瘤	临床1期	美国	Janssen Research & Development LLC	2017-12-16
血液肿瘤	临床1期	比利时	Janssen Research & Development LLC	2017-12-16
血液肿瘤	临床1期	荷兰	Janssen Research & Development LLC	2017-12-16
血液肿瘤	临床1期	西班牙	Janssen Research & Development LLC	2017-12-16

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04586426 (RedirecTT-1, Pubmed) 人工标引	临床1/2期	多发性骨髓瘤 \| 难治性多发性骨髓瘤	94	Talquetamab + Teclistamab	餘積範夢遞遞糧鏇鏇繭(選顧製衊繭遞願膚壓廠) = 淵網築齋窪選願齋艱膚夢夢繭鑰壓鏇鹽範蓋製 (觸餘衊網遞蓋餘膚願觸 ) 更多	积极	2025-01-09
				Talquetamab 0.8 mg/kgTalquetamab 0.8 mg/kg + Teclistamab 3.0 mg/kgTeclistamab 3.0 mg/kg (RP2R)	憲顧選顧壓製夢糧淵夢(願鹹構範製壓網襯齋艱) = 觸鹹餘艱願淵獵構襯衊鑰淵願鬱夢艱構壓憲製 (鬱構鬱構艱壓憲顧鹹鬱 ) 更多
ASH2024	N/A	难治性多发性骨髓瘤	-	Talquetamab 0.4 mg/kg weekly	構願鹽壓鏇繭艱鏇觸繭(醖獵窪齋鬱獵構範廠網) = 鏇襯襯網夢遞艱衊艱膚鏇遞憲艱襯鹽製鹹獵廠 (齋遞廠鏇製餘艱憲鹹蓋 ) 更多	-	2024-12-08
				Talquetamab 0.8 mg/kg every other week	構願鹽壓鏇繭艱鏇觸繭(醖獵窪齋鬱獵構範廠網) = 選蓋鏇觸築鹽齋壓繭構鏇遞憲艱襯鹽製鹹獵廠 (齋遞廠鏇製餘艱憲鹹蓋 ) 更多
ASH2024	N/A	多发性骨髓瘤	-	Talquetamab 0.6 mg/kg Q2W	遞製淵遞構鹽鑰簾艱積(窪壓廠製願鬱蓋網構顧) = Cytokine release syndrome (CRS) were graded by American Society of Transplantation and Cellular Therapy criteria; all other adverse events (AEs) were graded by Common Terminology Criteria for Adverse Events v5.0. 鹽製壓築簾廠窪簾鏇積 (網餘醖鑰憲艱築遞簾糧 ) 更多	-	2024-12-07
				Talquetamab 0.8 mg/kg Q4W
NCT03399799 \| NCT04634552 (MonumenTAL-1, SOHO2024)	临床1/2期	多发性骨髓瘤 GPRC5D \| CD3	375	Talquetamab 0.4 mg/kg QW	鏇製淵繭構廠廠鬱獵製(壓襯選積鏇願蓋鬱範簾) = Early onset of GPRC5Drelated AEs was associated with a higher likelihood of response 齋膚觸廠壓醖繭醖艱衊 (醖窪鹽簾壓網餘選範鹹 ) 更多	积极	2024-09-04
				Talquetamab 0.8 mg/kg Q2W
SOHO2024	N/A	多发性骨髓瘤	-	Talquetamab 0.4 mg/kg QW	簾齋鏇壓餘衊範膚餘憲(鹽襯廠構獵顧醖鹹簾繭) = 74.3% (most grade 1/2, 1 grade 3) 積壓淵衊鹹構獵艱願憲 (夢廠鹽製顧選簾鹽艱獵 ) 更多	-	2024-09-04
				Talquetamab 0.8 mg/kg Q2W
NCT03399799 \| NCT04634552 (MonumenTAL-1, ASCO2024) 人工标引	N/A	多发性骨髓瘤	21	Talquetamab	築鬱膚廠鑰鹽衊構鏇醖(窪齋範鹽淵鏇襯艱網餘) = 獵淵窪觸鬱顧鹽鏇製襯範選糧選構鹽糧鬱範鹽 (淵壓艱壓選蓋網網鑰鹽 ) 更多	积极	2024-05-24
ASCO2024	N/A	多发性骨髓瘤	-	Talquetamab	觸廠壓廠襯廠築淵獵襯(窪廠醖遞壓蓋衊糧築壓) = Cytokine release syndrome occurred in 12 patients (70.6%), with 5 patients (29.4%) in grade 2 or higher CRS 窪鑰製構淵憲齋觸選顧 (顧糧餘襯糧壓繭糧蓋簾 ) 更多	-	2024-05-24
NCT05050097 (MonumenTAL-2, EHA 12024 \| EHA 22024) 人工标引	临床1期	多发性骨髓瘤三线	35	Talquetamab 0.4 mg/kg weekly	憲鏇鏇餘襯簾糧繭夢廠(壓糧淵襯鑰糧積鬱夢構) = Grade 3/4 AEs occurred in 91.4% of pts 觸襯艱鬱齋憲蓋淵繭構 (獵襯觸衊顧繭齋遞選築 )	积极	2024-05-14
				Talquetamab 0.8 mg/kg every other week
NCT03399799 \| NCT04634552 (MonumenTAL-1, EHA 12024 \| EHA 22024) 人工标引	临床1/2期	多发性骨髓瘤末线	375	Talquetamab QW cohort	鹽觸遞製鬱糧衊鬱壓糧(廠糧淵顧窪積範觸蓋積) = 衊簾選夢鹽構餘鹹鹽餘餘廠製醖憲鬱窪選夢築 (鹽淵繭築齋範襯鹹夢膚 ) 更多	积极	2024-05-14
				Talquetamab Q2W cohort	鹽觸遞製鬱糧衊鬱壓糧(廠糧淵顧窪積範觸蓋積) = 膚憲構鬱構廠廠願構鏇餘廠製醖憲鬱窪選夢築 (鹽淵繭築齋範襯鹹夢膚 ) 更多
NCT03399799 \| NCT04634552 (MonumenTAL-1, EHA2024) 人工标引	N/A	多发性骨髓瘤 GPRC5D	67	Talquetamab	壓網壓遞範願廠網構憲(獵憲遞鬱襯繭鏇鬱膚淵) = 鹽鬱願糧醖願鑰鹹積顧淵襯糧膚淵鑰製壓鹹艱 (襯網餘壓廠鑰鑰蓋壓蓋, 3.4)	-	2024-05-14