AbbVie reported that its bispecific antibody epcoritamab (EPKINLY) achieved a statistically significant improvement in progression‑free survival (PFS) in the Phase 3 EPCORE DLBCL‑1 study, with a hazard ratio of 0.74 (95% CI 0.60‑0.92). The 26% reduction in the risk of disease progression or death was accompanied by higher complete‑response rates, longer duration of response, and a shorter time to next treatment in the epcoritamab arm compared with investigator‑chosen chemotherapy.
The trial did not meet its overall‑survival (OS) endpoint; the OS hazard ratio was 0.96 (95% CI 0.77‑1.20), falling short of statistical significance. AbbVie and Genmab cited the impact of the COVID‑19 pandemic and the increasing availability of other novel anti‑lymphoma therapies during the study period as potential contributors to the OS result.
The PFS benefit positions epcoritamab as a promising new option for patients with relapsed or refractory diffuse large B‑cell lymphoma who are ineligible for high‑dose chemotherapy and autologous stem‑cell transplant. However, the lack of an OS signal may temper enthusiasm among clinicians and regulators, and could influence the speed and scope of regulatory review. AbbVie and Genmab are engaging with global regulatory authorities to discuss next steps, including the possibility of accelerated approval based on the robust PFS data and the need for confirmatory studies to address the OS gap.
AbbVie’s oncology portfolio has expanded with recent approvals for epcoritamab in follicular lymphoma and other indications, and the company’s broader pipeline includes several bispecific and CAR‑T candidates. The EPCORE DLBCL‑1 results reinforce AbbVie’s strategic focus on high‑need lymphoma subtypes and support its competitive positioning against other bispecific and CAR‑T therapies. The company’s management emphasized that the PFS data demonstrate meaningful clinical benefit, while acknowledging the OS limitation and outlining plans to gather additional evidence.
The trial’s outcomes underscore the challenges of demonstrating overall survival benefit in heavily pre‑treated lymphoma populations, especially amid evolving treatment landscapes. AbbVie’s next‑step strategy will likely involve continued dialogue with regulators, potential supplemental data collection, and a focus on real‑world evidence to strengthen the overall benefit profile of epcoritamab in this patient population.
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