GMAB Clinical trials

Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

Published August 07, 2025 at 02:31 PM

COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) today announced positive results of the Phase 3 EPCORE® FL-1 trial evaluating subcutaneous epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R2) versus R2 alone for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study met its dual primary endpoints of overall response rate (ORR, p-value < 0.0001) and progression-free survival (PFS, HR 0.21, p-valu

Related Questions

Will the company raise additional capital or issue equity to fund commercial launch? How does the efficacy of the epcoritamab+R2 combo influence potential market share against competing bispecifics like Blincyto (blinatumomab) or other emerging FL therapies? How will the positive Phase 3 results affect Genmab's (GMAB) stock price in the short and long term? Will the trial results trigger any partnership, licensing, or acquisition interest from larger pharmaceutical companies? How will this impact Genmab's existing collaborations (e.g., with Roche) and future partnership negotiations? Will the dual primary endpoints lead to an upgrade in analyst coverage or target price revisions by sell‑side analysts? How does the safety profile and adverse event rate compare to the current standard of care? What is the expected timeline for FDA or EMA approval based on these results? What is the potential market size and revenue opportunity for subcutaneous epcoritamab in the FL market? How does the ORR and PFS data compare to existing treatments for R/R follicular lymphoma, such as GSK's obinutuzumab or Roche's rituximab combos? Are there any upcoming catalyst events (e.g., FDA advisory committee, submission dates) we should watch for? What are the projected sales and profit margins for epcoritamab if approved?