## Epcoritamab Shows Mixed Clinical Results in Advanced DLBCL: PFS Gains Outweighed by OS Concerns

AbbVie and Genmab released pivotal Phase 3 trial data for epcoritamab, a subcutaneous T-cell engaging bispecific antibody designed for patients battling relapsed or refractory DLBCL (diffuse large B-cell lymphoma). The results reveal a complex clinical picture: while the therapy achieved statistically significant progression-free survival (PFS) improvements, it failed to translate into meaningful overall survival (OS) benefits—a critical shortfall that has tempered initial enthusiasm around the treatment.

The EPCORE DLBCL-1 trial represents a watershed moment as the first Phase 3 study demonstrating PFS superiority for a CD3xCD20 bispecific monotherapy in R/R DLBCL patients. The global study enrolled 483 heavily pretreated patients, with 73% having received two or more prior therapy lines. Notably, all participants were ineligible for high-dose chemotherapy and autologous stem cell transplantation (HDT-ASCT)—positioning epcoritamab as a critical option for an otherwise limited patient population.

**Efficacy signals emerged beyond PFS**: Epcoritamab delivered noteworthy improvements in complete response rates and response durability compared to investigator-selected chemoimmunotherapy. The therapy also reduced time to next treatment initiation, suggesting potential quality-of-life benefits. However, these intermediate wins failed to translate into prolonged overall survival, raising questions about disease resistance patterns and long-term treatment efficacy in this aggressive lymphoma subset.

AbbVie and Genmab are actively investigating potential confounding variables, including pandemic-related disruptions and the emergence of competing anti-lymphoma agents during the study period. These factors may have influenced patient outcomes and trial dynamics in ways that dampened OS signals despite clear PFS advantages.

The regulatory pathway moves forward deliberately. Trial data will be presented at future medical conferences, with both companies engaging global regulators to chart the approval strategy. Notably, epcoritamab has already secured market authorization in specific lymphoma indications across 65+ countries, suggesting prior regulatory traction despite these latest findings.

Stock response reflected cautious optimism: AbbVie closed trading down 0.31% at $214.35, with modest after-hours recovery to $214.66. The modest reaction underscores investor recognition of the mixed nature of these clinical results—meaningful PFS progress tempered by the absence of definitive survival extension.

Pipeline development continues unabated. AbbVie and Genmab maintain active research programs exploring epcoritamab in monotherapy applications and combination strategies across multiple treatment settings and hematologic malignancies, suggesting confidence in the therapy's broader potential despite current DLBCL limitations.