India Pharma Outlook Team | Monday, 19 January 2026
AbbVie today announced topline results from the Phase 3 EPCORE DLBCL-1 study evaluating epcoritamab in adults with relapsed or refractory DLBCL.
The trial achieved its main endpoint by demonstrating statistically significant improvement in progression-free survival, as compared to investigator selected chemoimmunotherapy, having a hazard ratio of 0.74 (95% CI 0.60 to 0.92).
There was also improvement in the key secondary measures among patients treated with epcoritamab. These were an increase in the amount of complete responses, an increase in duration of response and increased time to next treatment. This study however did not demonstrate statistically significant improvement in overall survival with an OS hazard ratio of 0.96 (95% CI 0.77 to 1.20).
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The first Phase 3 trial to show a PFS advantage of a CD3xCD20 T-cell engaging bispecific antibody in the monotherapy of relapsed or refractory DLBCL is EPCORE DLBCL-1. It was a global, open-label trial that involved 483 patients, none of which was eligible to receive high-dose chemotherapy and autologous stem cell transplant. Almost three-quarters had undergone two or more lines of therapy before.
The safety profile was similar to the previously known safety of epcoritamab. AbbVie and Genmab observed that the COVID-19 Omicron surge and the availability of new treatments to lymphoma could have played a role in their results. All information will be presented at a subsequent healthcare conference, and consultations with international regulators will be held.
The most prevalent non-Hodgkin lymphoma is still DLBCL with approximately 25,000 new cases in the U.S. annually. Epkinly or Tepkinly, which is now marketed as Epcoritamab, is already indicated in over 65 countries in some of the indications of lymphoma.
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