The purpose of this study is to determine how effective and safe the combination of epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL).
* The names of the study drugs involved in this research study are:
* Epcoritamab (a type of antibody)
* Zanubrutinib (a type of Bruton tyrosine kinase inhibitor)
* Rituximab (a type of monoclonal antibody)

开始日期2025-02-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+2]

NCT06510361 / Not yet recruiting临床2期IIT

A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy

This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment.
The name of the study drug in this research study is:
-Epcoritamab (a type of antibody)

开始日期2024-12-01

申办/合作机构

Beth Israel Deaconess Medical Center, Inc.

[+1]

NCT06447376 / Not yet recruiting临床1期

Pilot Safety-feasibility Study of Cytokine Release Syndrome Prophylaxis and Treatment with Siltuximab Prior to Epcoritamab

The goal of this clinical trial is to is to determine the safety, feasibility and efficacy of siltuximab prophylaxis of cytokine release syndrome and neurotoxicity occurring after epcoritamab subcutaneous administration for participants with large b-cell lymphoma (DLBCL) or follicular lymphoma (FL).
Participants will receive siltuximab, prior to the injection of epcoritamab. Epcoritamab is administered in 28 day cycles for one year. After this injection, the physician will continue to watch participants for side effects and follow the condition for a minimum of 60 days.

开始日期2024-12-01

申办/合作机构

The Case Comprehensive Cancer Center

[+3]

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项与艾可瑞妥单抗相关的文献（医药）

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Reichert, Janice M ; Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-12-31·mAbs

A pivotal decade for bispecific antibodies?

Article

作者: Surowka, Marlena ; Klein, Christian

Bispecific antibodies (bsAbs) are a class of antibodies that can mediate novel mechanisms of action compared to monospecific monoclonal antibodies (mAbs). Since the discovery of mAbs and their adoption as therapeutic agents in the 1980s and 1990s, the development of bsAbs has held substantial appeal. Nevertheless, only three bsAbs (catumaxomab, blinatumomab, emicizumab) were approved through the end of 2020. However, since then, 11 bsAbs received regulatory agency approvals, of which nine (amivantamab, tebentafusp, mosunetuzumab, cadonilimab, teclistamab, glofitamab, epcoritamab, talquetamab, elranatamab) were approved for the treatment of cancer and two (faricimab, ozoralizumab) in non-oncology indications. Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium.

2024-08-01·Lancet Haematology

Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study

Article

作者: Gernhardt, Diana ; Christensen, Jacob Haaber ; Vitolo, Umberto ; Elliott, Brian ; Dinh, Minh H ; Tilly, Hervé ; Liu, Yan ; Gyan, Emmanuel ; Altıntaş, Işıl ; Cochrane, Tara ; Jurczak, Wojciech ; Cordoba, Raul ; Hutchings, Martin ; Chamuleau, Martine E D ; Vose, Julie M ; Lewis, David John ; Sancho, Juan-Manuel ; Thieblemont, Catherine ; Clausen, Michael Roost ; Favaro, Elena ; Sureda, Anna ; Linton, Kim M ; Okada, Craig ; Ahmadi, Tahamtan ; Lugtenburg, Pieternella J ; Leppä, Sirpa ; Hess, Brian ; Hoehn, Daniela

BACKGROUND:

A standard of care and optimal duration of therapy have not been established for patients with multiply relapsed or refractory follicular lymphoma. The aim of this study was to evaluate epcoritamab, a novel CD3 × CD20 bispecific antibody, in the third-line and later setting of follicular lymphoma.

METHODS:

EPCORE NHL-1 is a multicohort, single-arm, phase 1-2 trial conducted at 88 sites across 15 countries. Here, we report the primary analysis of patients with relapsed or refractory follicular lymphoma in the phase 2 part of the trial, which included the pivotal (dose expansion) cohort and the cycle 1 optimisation cohort. Eligible patients were aged 18 years or older, had relapsed or refractory CD20⁺ follicular lymphoma (grade 1-3A), an Eastern Cooperative Oncology Group performance status of up to 2, and had received at least two previous lines of therapy (including an anti-CD20 monoclonal antibody and an alkylating agent or lenalidomide). Patients were treated with subcutaneous epcoritamab 48 mg in 28-day cycles: weekly in cycles 1-3, biweekly in cycles 4-9, and every 4 weeks until disease progression or unacceptable toxicity. To mitigate the risk and severity of cytokine release syndrome, in the pivotal cohort, cycle 1 consisted of a step-up dosing regimen of a 0·16-mg priming dose on day 1 and a 0·80-mg intermediate dose on day 8, followed by subsequent 48-mg full doses and prophylactic prednisolone 100 mg; in the cycle 1 optimisation cohort, a second intermediate dose of 3 mg on day 15, adequate hydration, and prophylactic dexamethasone 15 mg were evaluated during cycle 1 to further reduce risk and severity of cytokine release syndrome. Primary endpoints were independently reviewed overall response rate for the pivotal cohort and the proportion of patients with grade 2 or worse and any-grade cytokine release syndrome for the cycle 1 optimisation cohort. Analyses were done in all enrolled patients who had received at least one dose of epcoritamab. This study is registered with ClinicalTrials.gov, NCT03625037, and is ongoing.

FINDINGS:

Between June 19, 2020, and April 21, 2023, 128 patients (median age 65 years [IQR 55-72]; 49 [38%] female and 79 [62%] male) were enrolled and treated in the pivotal cohort (median follow-up 17·4 months [IQR 9·1-20·9]). The overall response rate was 82·0% (105 of 128 patients; 95% CI 74·3-88·3), with a complete response rate of 62·5% (80 of 128; 95% CI 53·5-70·9). The most common grade 3-4 treatment-emergent adverse event was neutropenia in 32 (25%) of 128 patients. Grade 1-2 cytokine release syndrome was reported in 83 (65%) of 128 patients; grade 3 cytokine release syndrome was reported in two (2%). Immune effector cell-associated neurotoxicity syndrome was reported in eight (6%) of 128 patients (five [4%] grade 1; three [2%] grade 2). Between Oct 25, 2022, and Jan 8, 2024, 86 patients (median age 64 years [55-71]; 37 [43%] female and 49 [57%] male) were enrolled and treated in the cycle 1 optimisation cohort. The incidence of cytokine release syndrome was 49% (42 of 86 patients; eight [9%] grade 2; none of grade 3 or worse), with no reported immune effector cell-associated neurotoxicity syndrome.

INTERPRETATION:

Epcoritamab monotherapy showed clinically meaningful activity in patients with multiply relapsed or refractory follicular lymphoma, and had a manageable safety profile.

FUNDING:

Genmab and AbbVie.

270

项与艾可瑞妥单抗相关的新闻（医药）

2024-09-20

·Insight数据库

艾伯维联合开发，潜在重磅 CD20×CD3 双抗国内启动 Ⅲ 期临床，一线治疗滤泡性淋巴瘤

9 月 19 日，药物临床试验登记与信息公示平台显示，艾伯维在国内登记一项 Ⅲ 期临床试验，以在既往未接受过治疗的滤泡性淋巴瘤受试者中，评估 Epcoritamab + 利妥昔单抗和来那度胺对比化学免疫疗法的安全性和有效性。 Epcoritamab 是全球第 3 款获批的 CD20×CD3 双抗，也是国内研究进度较快的 CD20×CD3 双抗产品之一。该药曾被行业媒体 Evalute 列为 2023 年的十大潜在重磅疗法之一。截图来自：药物临床试验登记与信息公示平台 Epcoritamab 最初由 Genmab 公司开发，艾伯维在 2020 年与 Genmab 达成一项总额达 39 亿美元的合作，以共同开发和商业化 Genmab 的三种下一代双抗产品，其中就包括 Epcoritamab。 Epcoritamab 采用 Genmab 公司的 DuoBody 专利技术生产，该公司的 DuoBody-CD3 技术旨在将细胞毒性 T 细胞选择性导向肿瘤，以诱发对恶性肿瘤细胞的免疫反应。作为一款双特异性抗体，Epcoritamab 可同时与 T 细胞上的 CD3 和 B 细胞上的 CD20 结合，并诱发 T 细胞介导的淋巴瘤 B 细胞杀伤。 Epcoritamab 于 2023 年 5 月 19 日全球首批，获美国 FDA 批准治疗高级别 B 细胞淋巴瘤（三线）、弥漫性大 B 细胞淋巴瘤（DLBCL）。去年 9 月，该药又在日本获批上市，治疗滤泡性淋巴瘤、高级别 B 细胞淋巴瘤、纵隔大 B 细胞淋巴瘤、大 B 细胞淋巴瘤（三线）、弥漫性大 B 细胞淋巴瘤，并于同月获得欧盟 EMA 批准，治疗弥漫性大 B 细胞淋巴瘤（三线）。2023 年，上市仅 6 个月的 Epcoritamab 为艾伯维贡献了 3100 万美元的销售额。 2024 年以来，Epcoritamab 又获得了新的适应症拓展。今年 6 月和 8 月，该药分别获得 FDA 和 EMA 批准治疗滤泡性淋巴瘤（三线、末线）。根据艾伯维财报，2024 上半年，Epcoritamab 的全球销售额已达到 6300 万美元。随着新适应症的拓展，Epcoritamab 今年销售额突破 1 亿美元应该不是问题。 Epcoritamab 研究历史时光轴截图来自：Insight 数据库在中国，Epcoritamab 尚未获批。此前，艾伯维和 Genmab 已在国内启动三项 Epcoritamab 的 Ⅲ 期临床，针对的适应症分别为：皮下注射 Epcoritamab 联合 R-CHOP 治疗新诊断的弥漫大 B 细胞淋巴瘤（CTR20231626，EPCORE DLBCL-2），对照组为 R-CHOP（利妥昔单抗、环磷酰胺、盐酸多柔比星、长春新碱和泼尼松）； Epcoritamab 治疗复发/难治性弥漫大 B 细胞淋巴瘤患者，对照组为研究者选择的化疗（CTR20221558）；皮下注射 Epcoritamab 联合利妥昔单抗和来那度胺治疗复发或难治性滤泡性淋巴瘤（CTR20230864，EPCORE™ FL-1），对照组为利妥昔单抗和来那度胺（R2）。本次新登记的是一项多中心、随机、开放性试验（EPCORE™FL-2，CTR20243120），旨在既往未接受过治疗的滤泡性淋巴瘤受试者中评价 Epcoritamab + 利妥昔单抗和来那度胺对比化学免疫疗法的安全性和疗效。研究拟在国内入组 162 人，国际入组 1080 人。 CD20×CD3 双抗是血液癌症领域的热门药物。Insight 数据库显示，全球范围内现有 4 款 CD20×CD3 双抗获批，分别为罗氏/渤健的莫妥珠单抗、罗氏的格罗菲妥单抗、艾伯维/Genmab 的 Epcoritamab、再生元/再鼎医药的奥德罗奈昔单抗。在国内，目前仅有罗氏的格罗菲妥单抗获批上市，治疗弥漫性大 B 细胞淋巴瘤（三线）。罗氏/渤健的莫妥珠单抗已于去年 12 月在国内申报上市，用于治疗既往接受过至少两种系统性治疗的复发或难治性滤泡性淋巴瘤成人患者，Insight 数据库预测该申请有望于明年一季度获批。此外，还有 10 款 CD20×CD3 双抗已在国内进入临床阶段，来自艾伯维/Genmab、罗氏/渤健、再生元/再鼎医药、天广实、康诺亚/诺诚健华、嘉和生物、神州细胞、君实、正大天晴、爱思迈等公司。其中，进度最快的是 Epcoritamab、莫妥珠单抗皮下注射剂型，已在注册 Ⅲ 期阶段。 CD20×CD3 双抗国内研究进度概览图截图来自：Insight 数据库封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床3期财报临床1期免疫疗法临床2期

2024-09-16

·PRNewswire

Expanding the Bispecific Antibody Market from CAR-Ts to Drive Follicular Lymphoma's Future | DelveInsight

The competition in follicular lymphoma is rapidly intensifying, with three CAR-T therapies and three bispecific antibodies now approved for relapsed or refractory patients. As both classes of treatments expand, the battle for dominance in this market is growing, with each therapy offering unique advantages in accessibility, efficacy, and safety profiles, setting the stage for a dynamic shift in treatment strategies. LAS VEGAS, Sept. 16, 2024 /PRNewswire/ -- Follicular lymphoma is a type of non-Hodgkin lymphoma (NHL) that develops from B-lymphocytes and is generally slow-growing or indolent. This subtype represents 20–30% of all NHL cases. While follicular lymphoma typically progresses slowly, there are instances where it can grow more rapidly. Treatment options for follicular lymphoma include, chemotherapy, radiation therapy, immunotherapy, stem cell transplantation, CAR T-cell therapy, and bispecific-antibodies. For those in the early stages of the disease (Ann Arbor stages I or II), treatment may involve radiation therapy alone or in combination with chemotherapy. Patients with advanced follicular lymphoma are typically treated initially with a combination of chemotherapy and anti-CD20 antibodies, a method known as chemoimmunotherapy. The most commonly used antibodies are RITUXAN (rituximab) and GAZYVA (obinutuzumab), which specifically target tumor cells associated with follicular lymphoma. In older patients who do not have organ dysfunction, treatment with rituximab alone may be an option. Other therapies like ZEVALIN (yttrium-90 ibritumomab tiuxetan), TAZVERIK (tazemetostat), REVLIMID (lenalidomide), and others are approved for the treatment of follicular lymphoma. CAR T-cell therapies are becoming increasingly significant in treating follicular lymphoma. YESCARTA, a CD19-directed genetically modified autologous T-cell therapy, became the first CAR-T to be approved for follicular lymphoma by the US FDA in March 2021. Before the approval of YESCARTA, BREYANZI was approved in February 2021 for Grade 3B follicular lymphoma that accounts for about 5-10% of all follicular lymphoma cases. Later in April 2022 it was approved by the European commission. In May 2024 BREYANZI was approved for the treatment of relapsed/refractory follicular lymphoma who have received two or more prior lines of systemic therapy and provided sustained clinical benefit with median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months. In May 2022, Novartis announced that the European Commission approved KYMRIAH (tisagenlecleucel) for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more systemic therapies. This approval represents the third indication for KYMRIAH, making it the first CAR-T cell therapy sanctioned in Europe for such patients, including those with relapsed/refractory follicular lymphoma Grades 1, 2, and 3A. Additionally, in May 2022, the US FDA granted approval for KYMRIAH for the same patient group. Currently, autologous CAR-T therapies are the only ones approved, but the emerging pipeline predominantly comprises autologous CAR-Ts alongside a growing number of allogeneic CAR-T therapies. Allogeneic CAR-T, a newer term, refers to donor-derived therapies offering several advantages over autologous treatments. These off-the-shelf therapies are readily available, eliminating the need to modify patient cells either at a central manufacturing site or at the point of care. Even though the reimbursement of CAR-T therapies represents a challenge for healthcare providers, insurers, and government agencies, they have successfully reached the majority of the markets by considering the patient pool demand. While determining the cost and reimbursement, various factors, such as pharmacoeconomic analysis and outcome-based responses, as well as the added value to society, have been evaluated. The CAR T-cell-related toxicity, such as the cytokine-release syndrome and neurotoxicity, remain important potential complications of this therapy. Second generation CAR T-cell therapies are emerging with more safety and efficacy to overcome these limitations. If these limitations have been overcome, these are going to be the potential drivers of the market. After CAR-T approval companies focused on developing alternative therapies to overcome CAR-Ts limitations. LUNSUMIO became the first bispecific antibody to get approval for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more lines of systemic treatment in June 2022 in Europe. Later in December 2022, the US FDA approved it for the same indication. This was the game changing step toward a brighter future for follicular lymphoma patients. Bispecific antibodies are ready to use therapies and safer treatment options than CAR-Ts. In 2023, LUNSUMIO captured USD 55 million in revenue in the United States for follicular lymphoma. In the United States, AbbVie and Genmab's epcoritamab, marketed as EPKINLY, first gained FDA approval in May 2023 for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This was followed by its approval for follicular lymphoma in June 2024. With the recent FDA authorization for relapsed/refractory follicular lymphoma, along with expected approvals and launches in international markets, EPKINLY is poised to see revenue growth in the coming quarters. Its strong performance in treating relapsed/refractory DLBCL suggests it could achieve similar success in follicular lymphoma. LUNSUMIO now faces competition in the European market for follicular lymphoma, as on August 19, 2024, the European Commission granted approval for the expanded use of AbbVie and Genmab's bispecific antibody, TEPKINLY (epcoritamab), for treating adults with relapsed/refractory follicular lymphoma. The study showed an overall response rate of 83% and a complete response rate of 63%, with the median response duration being 21.4 months. Just after TEPKINLY approval in Europe, Regeneron's ORDSPONO (odronextamab) a CD20 x CD3 bispecific antibody approved by European Commission on August 26, 2024 for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory DLBCL, after two or more lines of systemic therapy. After this approval, ORDSPONO becomes the first off-the-shelf option that can be administered in the out-patient setting. In March 2024, the US FDA declined approval for odronextamab for treating follicular lymphoma and DLBCL. The agency issued two complete response letters concerning the biologics license application (BLA) for odronextamab in relapsed/refractory follicular lymphoma and DLBCL after two or more lines of systemic therapy. The denial was tied to the enrollment status of confirmatory trials assessing the drug. Importantly, there were no concerns raised about odronextamab's efficacy, safety, trial design, labeling, or manufacturing. Both EPKINLY, LUNSUMIO, and ORDSPONO are off-the-shelf therapies, offering greater accessibility compared to CD19 CAR-T treatments. These drugs will compete not only with each other but also with CAR-T therapies to secure a substantial portion of the follicular lymphoma market. Learn more about the FDA-approved follicular lymphoma drugs @ Drugs for Follicular Lymphoma Treatment A new class has also emerged for the treatment of follicular lymphoma, i.e., Bruton tyrosine kinase (BTK) inhibitors. In November 2023, BeiGene received approval from the European Commission for BRUKINSA (zanubrutinib) to treat relapsed/refractory follicular lymphoma. Later in March 2024, the US FDA approved BRUKINSA for the same indication. BRUKINSA is the first and only BTK inhibitor approved for this condition. To know more about follicular lymphoma treatment options, visit @ New Treatment for Follicular Lymphoma The follicular lymphoma pipeline is robust with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include AbbVie's IMBRUVICA, Xynomic Pharmaceuticals' Abexinostat, Pfizer PF-06821497, Incyte's Parsaclisib, Bristol-Myers Squibb's Nivolumab, and others. Discover which therapies are expected to grab major follicular lymphoma market share @ Follicular Lymphoma Market Report IMBRUVICA (ibrutinib) is an anti-cancer medication available in various forms, including hard gelatin capsules, tablets, film-coated tablets, and oral suspension. It is being developed by AbbVie and is currently undergoing Phase III trials for follicular lymphoma. This study aims to determine if adding ibrutinib to the treatment will extend progression-free survival (PFS) compared to using rituximab alone in patients with newly diagnosed follicular lymphoma. Xynomic Pharmaceuticals is developing Abexinostat for treating follicular lymphoma. The company is currently testing this investigational drug in a Phase II clinical trial involving patients with relapsed/refractory follicular lymphoma who have received at least three prior therapies. The US FDA has granted Abexinostat fast-track designation for this use. In June 2021, Xynomic completed a short-form merger with Xu-Nuo Pharma in a "Going Private" transaction. Post-merger, Xu-Nuo Pharma will continue Xynomic's business as its main focus. Discover more about drugs for follicular lymphoma in development @ Follicular Lymphoma Clinical Trials The anticipated launch of these emerging therapies for follicular lymphoma are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the follicular lymphoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for follicular lymphoma is expected to grow from USD 1.4 billion in 2020 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rise in the increasing incidence of follicular lymphoma. DelveInsight's latest published market report titled as Follicular Lymphoma Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the follicular lymphoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The follicular lymphoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Follicular Lymphoma Risk-specific Incident Cases of Follicular Lymphoma Stage-specific Incident Cases of Follicular Lymphoma Mutation-specific Incident Cases of Follicular Lymphoma Transplant Eligible and Ineligible Patient Pool of Follicular Lymphoma Refractory/Relapsed Incident Cases of Follicular Lymphoma The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM follicular lymphoma market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis up to 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this follicular lymphoma market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the follicular lymphoma market. Also, stay abreast of the mitigating factors to improve your market position in the follicular lymphoma therapeutic space. Related Reports Follicular Lymphoma Pipeline Follicular Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key follicular lymphoma companies, including Incyte Corporation, Genmab A/S, BeiGene, Merck & Co., ADC Therapeutics, Xynomic Pharmaceuticals, Nordic Nanovector, TG Therapeutics Inc, Allogene Therapeutics, MEI Pharma, Innovent Biologics, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. 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临床2期免疫疗法上市批准快速通道临床3期

2024-08-29

·艾美达医药咨询

实现每年数十亿美元利润后，这家License-out模式选手开始买公司

作为一家成立后一年就获得IPO的抗体公司，Genmab早在二十多年前就创下了欧洲生物技术的纪录。现在，Genmab依靠以达雷妥尤单抗为主的若干全球销量TOP100重磅产品的销售分成，实现了每年数十亿美元的利润，并且这样的潜在明星单抗分子数目还在不断增加。目前已有8项使用了Genmab创新成果的疗法获得批准，约20项产品正在临床开发中。 2024年8月19日，AbbVie和Genmab共同宣布欧盟委员会（EC）已授予TEPKINLY®（epcoritamab）有条件上市授权，作为二线或多线治疗后复发或难治性（R/R）滤泡性淋巴瘤（FL）成年患者的单一疗法。这也是Tepkinly获得的第二次欧盟批准，作为适应症扩展。 1 重磅双特异性抗体疗法Tepkinly Tepkinly是一种皮下注射双特异性抗体，可与T细胞上的CD3受体和B细胞表面常见的CD20蛋白结合。这种作用机制使Tepkinly能够激活T细胞，诱导促炎细胞因子的释放，促进恶性B细胞的破坏。这种独特的作用机制使得Tepkinly在难治性滤泡性淋巴瘤患者中显示出显著的治疗潜力。该分子最初由Genmab开发，公司于2020年6月从AbbVie获得了7.5亿美元的预付款，总生物资金预计可达35亿美元，两家公司正在共同推进该疗法的商业化。早在2022年2月，Tepkinly就首次获得欧盟批准，用于复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）的三线治疗。AbbVie表示，本次的适应症扩展使Tepkinly成为“第一个也是唯一一个”欧盟批准的皮下双特异性T细胞接合剂（BiTE），适用于复发或难治性滤泡性淋巴瘤（FL）或弥漫性大B细胞淋巴瘤。目前，Tepkinly在全球已经获得11项批准（药渡数据）。2024年上半年，TEPKINLY在Genmab获得特许权使用费收入的地区净销售额超1亿美元。本次有条件上市授权得到了1/2期EPCORE®NHL-1临床试验数据的支持：这是一项开放标签、多队列、多中心、单臂试验，该研究包括对抗CD20单克隆抗体治疗和烷化剂均难治的患者（70%患有双重难治性疾病），对先前治疗难治的患者（82%），以及在开始任何首次全身治疗后两年内疾病进展的患者（52%）。发表在《柳叶刀血液学》上的结果显示，接受Tepkinly治疗的患者（n=128）总体反应率（ORR）为83%，完全反应率（CR）为63%。中位随访16.2个月，中位反应持续时间为21.4个月。除了疗效显著外，Tepkinly的安全性数据也较为理想。在临床试验的优化队列中，没有报告高级别的细胞因子释放综合征（CRS）或免疫效应细胞相关神经毒性综合征（ICANS）的情况。相较于其他产品，Tepkinly疗效和安全性的双重优势有望为患者带来新的治疗希望。弥漫性大B细胞淋巴瘤是我国人群最常见的淋巴瘤类型，目前R-CHOP治疗方案能显著延长各阶段患者的生存，但是部分一线高危患者和复发难治型患者仍面临着治疗效果差、成本高的生存困境。目前获批且常用的药物包括靶向CD79b的抗体药物偶联物优罗华®（维泊妥珠单抗）、双抗高罗华®（格菲妥单抗）。总的来说，弥漫性大B-细胞淋巴瘤批准上市的药物有超100个，临床阶段的药物有约250个；滤泡性淋巴瘤批准上市的药物有83个，临床阶段的药物有约150个。 2 Genmab半年财报亮眼八月初，Genmab发布了2024年上半年财报，总收入为95.45亿丹麦克朗（约合14亿美元），与2023年上半年相比其收入增长了36%。25.42亿丹麦克朗（36%）的增长主要来自与杨森生物技术公司（Janssen）合作获得的DARZALEX®（daratumumab）特许权使用费，以及和诺华制药公司（Novartis Pharma AG）合作获得的KESIMPTA®（ofatumumab）特许权使用费，外加Epkinly净产品销售额的增加。2024年上半年总的特许权使用费收入为76.73亿丹麦克朗，而2023年上半年为58.86亿丹麦克朗。此外，在2024年第二季度，Genmab达成了一系列重要里程碑，包括18亿美元收购普方生物（ProfoundBio），以及获得EPKINLY和Tivdak的监管批准，这进一步巩固了Genmab在差异化抗体疗法开发领域的地位。 3 License-out模式宗师级选手 License-out模式是指企业进行药物早期研发，然后将项目授权给其他药企做后期临床研发和上市销售，按里程碑模式获得各阶段临床成果以及商业化后的一定比例销售分成，收入可包含意向金、首付款、研发里程碑付款、销售里程碑付款、销售提成、终止履约金（分手费）等类目。 Genmab是欧洲创新药license-out的鼻祖之一，在公司成立那年便与Amgen就IL-15抗体（AMG714）达成合作。经过25年的发展，Genmab现在的代表性技术平台包括DuoBody®（双抗）、HexaBody®（六抗）、DuoHexaBody®和HexElect®，它们建立在天然抗体生物学的基础上，旨在利用人类免疫系统的力量抗击各种疾病。 DuoBody®平台能够稳定高效地大批量产生双特异性抗体，早在2012年7月，Genmab就与Janssen达成合作，利用DuoBody®平台开发双特异性抗体。HexaBody®平台能够创造强效疗法。在细胞表面靶向结合后，它诱导抗体六聚体的形成。这可以帮助产生强效的细胞毒性抗体，并用于触发诱导程序性细胞死亡的受体。这个技术可以将补体依赖性细胞毒性有限或缺失的抗体，转化为强效的细胞毒性抗体。HexaBody®平台也可以与其他平台联合使用。 Genmab通过几大技术平台进行差异化创新研发的策略为其多项license-out项目埋下伏笔。其中，关键的几次项目合作包括： 2020年，Genmab与AbbVie签订合作协议，共同开发和商业化epcoritamab。两家公司在美国和日本共同承担商业化责任，AbbVie负责其他的全球商业化。Genmab从美国和日本以外的其他全球销售额中获得22%至26%的分层特许权使用费。 2019年，Genmab与Janssen签订了全球独家许可和期权协议以开发和商业化GEN3014。其主要适应症为多发性骨髓瘤。临床前试验中，GEN3014表现出增强的补体依赖性细胞毒性和强大的抗肿瘤活性。 Daratumumab由Janssen根据Genmab的全球独家许可进行开发和商业化。根据协议条款，Genmab将获得12%至20%的特许权使用费。目前Genmab正在进行的5个3期临床的项目分别与Pfizer、BioNTech、AbbVie合作。由合作伙伴销售的许可产品有三项，包括Janssen、Novartis、Horizon的合作产品。 4 结语从Genmab产品的适应症来看，主要布局的是实体瘤、血液肿瘤，特别是那些难治的、易复发的肺癌和淋巴癌。这些癌种也是抗体类药物可以发挥独特作用的领域。Genmab许多药物都有多种临床阶段的适应症在研，也反映了使用免疫系统打击癌症这一策略的广泛适用性。从license out模式到收购普方生物，Genmab开始寻找新的增长引擎。从另一方面来看，中国创新药企正在迅速崛起。参考来源： 1. https://www.biospace.com/policy/abbvie-genmab-secure-european-label-expansion-for-tepkinly-in-follicular-lymphoma. August 20, 2024 2. Abbvie官网 3. Genmab官网 4. www.sec.gov 5. 药渡数据库 6. 景红梅：有用的新药好药都能纳入医保，是临床医生的朴素想法. https://www.eeo.com.cn/2024/0812/678891.shtml 2024-08-12 20:40 本文转载自Being科学/嘤嘤嘤免责声明本文系转载，仅做分享之用，不代表平台观点。图片、文章、字体等版权均属于原作者所有，如有侵权请告知，我们会及时处理。 ------------------------------ 「长按」二维码添加小达「进群」与更多行业伙伴共探市场前沿资讯艾美达医药咨询艾美达（北京）医药信息咨询有限公司，成立于2014年4月，是一家专业的医药行业咨询服务提供商。公司致力于将产业政策研究与真实世界的数据挖掘深度结合，洞悉行业政策对市场的影响，通过专业的研究提供前瞻性的市场分析，为企业产品上市后的市场准入提供整体解决方案。

引进/卖出临床1期临床2期IPO突破性疗法

100 项与艾可瑞妥单抗相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
纵隔大b细胞淋巴瘤	日本	Genmab A/S	2023-09-25
复发性滤泡性淋巴瘤	日本	Genmab A/S	2023-09-25
难治性滤泡性淋巴瘤	日本	Genmab A/S	2023-09-25
复发性弥漫性大B细胞淋巴瘤	欧盟	AbbVie Deutschland GmbH & Co. KG	2023-09-22
复发性弥漫性大B细胞淋巴瘤	冰岛	AbbVie Deutschland GmbH & Co. KG	2023-09-22
复发性弥漫性大B细胞淋巴瘤	列支敦士登	AbbVie Deutschland GmbH & Co. KG	2023-09-22
复发性弥漫性大B细胞淋巴瘤	挪威	AbbVie Deutschland GmbH & Co. KG	2023-09-22
难治性弥漫性大 B 细胞淋巴瘤	欧盟	AbbVie Deutschland GmbH & Co. KG	2023-09-22
难治性弥漫性大 B 细胞淋巴瘤	冰岛	AbbVie Deutschland GmbH & Co. KG	2023-09-22
难治性弥漫性大 B 细胞淋巴瘤	列支敦士登	AbbVie Deutschland GmbH & Co. KG	2023-09-22
难治性弥漫性大 B 细胞淋巴瘤	挪威	AbbVie Deutschland GmbH & Co. KG	2023-09-22
弥漫性大B细胞淋巴瘤	美国	Genmab, Inc.	2023-05-19
高级别B细胞淋巴瘤	美国	Genmab, Inc.	2023-05-19

未上市

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适应症	最高研发状态	国家/地区	公司	日期
滤泡性淋巴瘤	临床3期	澳大利亚	AbbVie, Inc.	2022-09-20
滤泡性淋巴瘤	临床3期	奥地利	AbbVie, Inc.	2022-09-20
滤泡性淋巴瘤	临床3期	比利时	AbbVie, Inc.	2022-09-20
滤泡性淋巴瘤	临床3期	丹麦	AbbVie, Inc.	2022-09-20
滤泡性淋巴瘤	临床3期	法国	AbbVie, Inc.	2022-09-20
滤泡性淋巴瘤	临床3期	匈牙利	AbbVie, Inc.	2022-09-20
滤泡性淋巴瘤	临床3期	以色列	AbbVie, Inc.	2022-09-20
滤泡性淋巴瘤	临床3期	意大利	AbbVie, Inc.	2022-09-20
滤泡性淋巴瘤	临床3期	新西兰	AbbVie, Inc.	2022-09-20
滤泡性淋巴瘤	临床3期	韩国	AbbVie, Inc.	2022-09-20

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临床结果

适应症

分期

评价

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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


NCT03625037 (EPCORE NHL-1, Pubmed)	临床2期	难治性滤泡性淋巴瘤三线 CD20	128	Epcoritamab 48 mg	夢觸願構夢襯糧醖觸鑰(製選憲憲鹽鹽餘範築壓) = 6% of patients experienced immune effector cell-associated neurotoxicity syndrome with Epcoritamab 48 mg 範選簾襯簾鑰襯夢築簾 (淵窪鹽夢餘鹹襯憲醖憲 ) 更多	积极	2024-06-13
NCT04663347 (EPCORE NHL-2, ASCO2024) 人工标引	临床1/2期	弥漫性大B细胞淋巴瘤 CD20 Positive	97	Epcoritamab + GemOx	願願夢憲範鏇夢製網網(構醖遞鏇選選餘遞簾壓) = 鑰範窪壓構構壓築醖齋衊鏇蓋鏇窪窪衊廠範夢 (積鹹膚網醖鬱製蓋鏇選 ) 更多	积极	2024-05-24
				Epcoritamab + GemOx (Kaplan–Meier estimates at 9 mo in pts with CR)	鏇艱憲選鬱築齋餘醖窪(窪製網鹹齋蓋網壓廠範) = 憲構餘蓋顧鬱蓋襯遞膚範積鏇構鑰觸願齋衊鏇 (獵膚構鬱膚膚醖壓廠遞 ) 更多
NCT04663347 (EPCORE™ NHL-2, ASCO2024) 人工标引	临床1/2期	弥漫性大B细胞淋巴瘤二线 CD20 Positive	29	Epcoritamab + R-DHAX/C	夢糧選鏇網鏇簾廠願鹽(衊壓淵糧餘鬱壓壓網夢) = 獵願遞鏇選獵獵淵積淵簾獵構憲願築齋糧鏇構 (膚製淵鏇廠廠網壓鬱夢 ) 更多	积极	2024-05-24
				Epcoritamab + R-DHAX/C (Progressed within 12 mo of initial tx)	夢糧選鏇網鏇簾廠願鹽(衊壓淵糧餘鬱壓壓網夢) = 醖窪顧蓋鹽範憲遞鑰網簾獵構憲願築齋糧鏇構 (膚製淵鏇廠廠網壓鬱夢 ) 更多
NCT03625037 (EPCORE NHL-1, ASCO2024) 人工标引	临床1/2期	滤泡性淋巴瘤三线 CD20 Positive	86	Epcoritamab (C1 OPT Cohort)	簾窪鹹願壓襯鏇範鏇淵(淵獵艱遞積顧餘廠遞鹽) = 鏇糧網範選淵顧壓醖願繭齋淵齋遞蓋範壓蓋廠 (構膚遞遞鏇衊製淵壓獵 ) 更多	积极	2024-05-24
				epcoritamab (Pivotal Cohor)	簾窪鹹願壓襯鏇範鏇淵(淵獵艱遞積顧餘廠遞鹽) = 願淵餘醖餘齋鬱糧廠鏇繭齋淵齋遞蓋範壓蓋廠 (構膚遞遞鏇衊製淵壓獵 ) 更多
NCT03625037 (NHL-1 EPCORE, ASCO2024) 人工标引	临床2期	高级别B细胞淋巴瘤 \| 弥漫性大B细胞淋巴瘤二线 CD20 Positive	157	Epcoritamab (DLBCL)	淵鏇鬱艱構餘積糧鬱艱(遞積艱築製艱襯觸糧餘) = 遞艱醖選夢衊繭願選鏇醖艱觸夢憲憲簾獵鑰蓋 (構選窪繭積衊衊簾製憲 ) 更多	积极	2024-05-24
				Epcoritamab	淵鏇鬱艱構餘積糧鬱艱(遞積艱築製艱襯觸糧餘) = 鹽簾餘淵簾構顧鹽醖餘醖艱觸夢憲憲簾獵鑰蓋 (構選窪繭積衊衊簾製憲 ) 更多
NCT05451810 (EPCORE NHL-6, ASCO2024) 人工标引	临床2期	滤泡性淋巴瘤 \| 弥漫性大B细胞淋巴瘤三线	36	SC epcoritamab (Priming SUD1)	廠膚蓋網壓衊鏇醖鑰築(窪艱艱選簾壓衊壓鹹膚) = 簾艱醖願築簾艱簾蓋憲蓋範淵醖壓構範願鏇繭 (鑰齋鏇壓襯憲艱窪鹹醖 ) 更多	积极	2024-05-24
				SC epcoritamab (Intermediate SUD2)	廠膚蓋網壓衊鏇醖鑰築(窪艱艱選簾壓衊壓鹹膚) = 夢遞顧獵獵築獵網艱簾蓋範淵醖壓構範願鏇繭 (鑰齋鏇壓襯憲艱窪鹹醖 ) 更多
NCT03888105 \| NCT02500407 \| NCT03625037 (ELM-2, EHA2024) 人工标引	N/A	滤泡性淋巴瘤三线 CD3 \| CD20	81	Epcoritamab	襯顧築選鑰網窪構觸襯(糧網膚膚選繭醖築繭鹽) = 願餘餘構觸鬱憲淵壓襯齋鏇觸積構範繭糧選鏇 (鹹構鑰選衊鬱蓋簾願繭 ) 更多	积极	2024-05-14
				Mosunetuzumab	襯顧築選鑰網窪構觸襯(糧網膚膚選繭醖築繭鹽) = 蓋繭簾構鑰範鑰淵餘艱齋鏇觸積構範繭糧選鏇 (鹹構鑰選衊鬱蓋簾願繭 ) 更多
NCT03625037 (EPCORE NHL-1, EHA2024) 人工标引	临床1/2期	滤泡性淋巴瘤三线 bispecific antibody	278	Epcoritamab	襯築衊鏇鹹鹽築築鹹壓(選蓋蓋鹽餘憲積壓壓繭) = 鏇淵簾鬱鏇鹹醖築襯積簾構願蓋衊廠積願網願 (鏇膚獵構夢遞膚製餘範, 63.5 ~ 75.1) 更多	积极	2024-05-14
				Epcoritamabcohort	襯築衊鏇鹹鹽築築鹹壓(選蓋蓋鹽餘憲積壓壓繭) = 製繭醖窪顧襯壓鬱積衊簾構願蓋衊廠積願網願 (鏇膚獵構夢遞膚製餘範, 17.9 ~ 28.5) 更多
NCT04623541 (EPCORE CLL-1, EHA2024) 人工标引	临床1/2期	里氏综合症 CD20 Positive	35	Epcoritamab 48 mg	淵餘餘醖積選憲衊淵鑰(獵鹽觸醖鑰網艱築艱遞) = 蓋構齋鹹繭鏇網築淵積築膚鏇膚鏇糧遞顧願壓 (廠廠膚選醖築選鹽積積 ) 更多	积极	2024-05-14
SCHOLAR-5 (EHA2024) 人工标引	N/A	滤泡性淋巴瘤三线	128	Epcoritamab	蓋顧鏇鏇蓋淵鹽製鏇願(觸鏇鏇積鹽衊鏇憲鑰構) = 淵鬱鹹簾淵繭淵鬱選衊醖廠艱簾顧顧窪選範餘 (網觸蓋夢鬱製鬱願襯淵 ) 更多	积极	2024-05-14
				Standard of Care (SoC)	蓋顧鏇鏇蓋淵鹽製鏇願(觸鏇鏇積鹽衊鏇憲鑰構) = 選衊鬱衊壓壓鏇襯網簾醖廠艱簾顧顧窪選範餘 (網觸蓋夢鬱製鬱願襯淵 ) 更多