On September 19, the Drug Clinical Trial Registry and Information Disclosure Platform showed that AbbVie registered a Phase III clinical trial in China.Previously Untreated Follicular LymphomaAmong the subjects, the evaluationEpcoritamab + Rituximab and LenalidomideComparisonChemoimmunotherapySafety and effectiveness.Epcoritamab isThe Third CD20×CD3 Bispecific Antibody Approved Globally, and also has a relatively fast research progress in China.One of the CD20×CD3 bispecific antibody products. The drug was listed by the industry media Evaluate as one of the top ten potential blockbuster therapies in 2023.
Screenshot from:Drug Clinical Trial Registration and Information Disclosure PlatformEpcoritamab Originally developed by Genmab,AbbVie in 2020 withGenmab Reaches an AgreementA collaboration totaling $3.9 billion toCo-develop and commercialize Genmab's three next-generation bispecific antibody products,Which includes Epcoritamab。Epcoritamab is produced using Genmab's proprietary DuoBody technology.The company's DuoBody-CD3 technology is designed to selectively direct cytotoxic T cells to tumors in order to induce an immune response against malignant tumor cells.As a bispecific antibody,Epcoritamab can simultaneously bind to CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of lymphoma B cells.。
Epcoritamab Globally First Launched on May 19, 2023, approved by the U.S. FDA for the treatment of high-grade B-cell lymphoma (Third-line), Diffuse Large B-Cell Lymphoma (DLBCL). Last September,The drug has been approved for marketing in Japan again., for the treatment of follicular lymphoma, high-grade B-cell lymphoma, mediastinal large B-cell lymphoma, and large B-cell lymphoma (Third-tier), Diffuse Large B-Cell Lymphoma, and received EU EMA approval in the same month, for the treatment of diffuse large B-cell lymphoma (third-line). In 2023,Epcoritamab, Launched Just 6 Months Ago, Contributed $31 Million in Sales to AbbVie。Since 2024, Epcoritamab has gained new indications. In June and August this year, the drug received FDA and EMA approval respectively for the treatment of follicular lymphoma (Third-line, Last-line`). According to AbbVie's financial report,`In the first half of 2024, the global sales of Epcoritamab have reached 63 million US dollars.With the expansion of new indications, Epcoritamab's sales this year are expected to exceed $100 million without any problem.Epcoritamab Research Historical Timeline
Screenshot source: Insight DatabaseIn China, Epcoritamab has not yet been approved. Previously, AbbVie and Genmab had initiated three Phase III clinical trials of Epcoritamab in China, targeting the following indications:- Subcutaneous Injection of Epcoritamab Combined with R-CHOP TreatmentNewly Diagnosed Diffuse Large B-Cell Lymphoma（CTR20231626，EPCORE DLBCL-2), Control group is R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone）；
- Epcoritamab TreatmentRelapsed/Refractory Diffuse Large B-Cell LymphomaPatients, the control group was the chemotherapy selected by the researchers (CTR20221558）；
- Subcutaneous Injection of Epcoritamab Combined with Rituximab and Lenalidomide for TreatmentRelapsed or Refractory Follicular Lymphoma（CTR20230864，EPCORE™ FL-1), Control group: Rituximab and Lenalidomide (R2）。
This newly registered study is a multicenter, randomized, open-label trial (EPCORE™FL-2，CTR20243120), aiming toPreviously Untreated Follicular LymphomaEvaluation of the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide Versus Chemoimmunotherapy in Subjects. The study plans to enroll 162 participants in China and 1080 participants internationally.CD20×CD3 bispecific antibody is a popular drug in the field of hematological cancers. According to the Insight database,Four CD20×CD3 bispecific antibodies have been approved worldwide., respectively Roche/Biogen's Muratuzumab, Roche's Glofitamab, AbbVie/Genmab's Epcoritamab, and Regeneron/Zai Lab's Odronextamab.In China, currently only Roche's Gropfimab has been approved for marketing., Treatment of Diffuse Large B-Cell Lymphoma (Third-line). Roche/Biogen'sMotozumab was submitted for marketing approval in China last December.for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies, Insight database predicts that this application is expected to be approved in the first quarter of next year.In addition,In China, 10 CD20×CD3 bispecific antibodies have entered the clinical stage.From AbbVie/Genmab, Roche/Biogen, Regeneron/Zai Lab, Mabworks, Conmana/Northern Biotech, Genor Biopharma, Sinocelltech, Junshi Biosciences, Chia Tai Tianqing, Aisimai, and other companies. Among them, the fastest progress is Epcoritamab and Motiximab subcutaneous injection formulation, which are already in Phase III registration.
Overview of the Research Progress of CD20×CD3 Bispecific Antibodies in China
Screenshot source: Insight DatabaseCover Source:ZCOOL Hello PlusDisclaimer:This article is for information sharing only, and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.PR Article Coordination: WeChat insightxbSubmissionWeChat: insightxb; Email: insight@dxy.cn
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