Epcoritamab Improves PFS but Not OS in Phase 3 DLBCL Trial
The companies plan regulatory talks following a randomized study in transplant‑ineligible relapsed DLBCL that compared subcutaneous monotherapy against standard chemoimmunotherapy.
Overview
- Epcoritamab monotherapy achieved a statistically significant progression‑free survival benefit versus investigator’s choice chemoimmunotherapy (HR 0.74; 95% CI 0.60–0.92).
- The study did not show a statistically significant overall survival improvement at the time of analysis (HR 0.96; 95% CI 0.77–1.20).
- The global trial enrolled 483 patients with relapsed or refractory DLBCL who had received at least one prior therapy and were ineligible for high‑dose chemotherapy and autologous stem cell transplant.
- Patients on epcoritamab showed higher complete response rates, longer duration of response, and a longer time to next treatment compared with the control arm.
- Adverse events were consistent with the known safety profile, and Genmab and AbbVie will submit full data to a medical meeting and engage regulators as additional Phase 3 readouts are expected in 2026.