AbbVie's Bispecific Antibody Epcoritamab Shows 95.7% ORR in Phase III Trial, Nominated for Priority Review in China
AbbVie
Innovative Drug Developer
EculizumabGlobally First Launched in May 2023。As of now, the drugHas been approved for marketing in the United States, the European Union, and Japan, with approved indications coveringDiffuse Large B-Cell Lymphoma, Follicular Lymphoma, Primary Mediastinal Large B-Cell Lymphoma. 2024，EculizumabGlobal sales were $281 million。
Screenshot source: Insight Database
In China,AbbVie submitted in November 2024The first marketing application for Epcoritamab Injection Concentrate, speculationIndications for Use:Relapsed/Refractory Diffuse Large B-Cell Lymphoma。
The indication for which this priority review is intended isEculizumabCombination of Rituximab and LenalidomideFor the treatment of relapsed or refractoryFollicular Lymphoma.
In the pivotal Phase III study EPCORE FL-1（NCT05409066）In the trial, researchers evaluated the safety and efficacy of Epcoritamab + Rituximab + Lenalidomide in treating patients with relapsed/refractory follicular lymphoma, while the control group received Rituximab + Lenalidomide. The dual primary endpoints of the trial were ORR and PFS.
The initial interim analysis data of the trial showed,ORR was 95.7%(p value < 0.0001)，PFS(HR 0.21, p-value < 0.0001)It is also statistically significant. Based on this result, the U.S. FDA accepted the application for epcoritamab + rituximab + lenalidomide for the treatment of relapsed/refractory follicular lymphoma on July 24 this year, and granted it priority review.PDUFA Date: November 30, 2025。
On August 7, 2025, Genmab announcedEPCORE FL-1 Clinical Trial Met Both Primary Endpoints of ORR and PFS. The eptinezumab group showed statistically significant and clinically meaningful differences in both endpoints,Reduced the risk of disease progression or death by 79%. The specific data of the study will be presented at the 67th American Society of Hematology（ASH）Presented at the annual meeting.
Insight database shows,Globally, there are currently 4 approved CD20×CD3 bispecific antibodies., respectively Roche/Biogen's Motuzumab, Roche's Glociflumab, AbbVie/Genmab'sEculizumabRegeneron/Zai Lab's Odronextamab.In China, currently only glofitamab,MotozumabApproved for marketing.
Overview of the Research Progress of CD20×CD3 Bispecific Antibodies in China
