Epcoritamab Demonstrates Durable 3-Year Responses in Relapsed or Refractory Follicular Lymphoma

Presented by

Yasmin Karimi, MD

Conference

SOHO 2025

Three-year follow-up from the EPCORE NHL-1 and NHL-3 expansion cohorts confirms that epcoritamab monotherapy provides deep and durable responses with a manageable safety profile in patients with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥2 prior lines of therapy.

Yasmin Karimi, MD, presented these results at the 13th Society of Hematologic Oncology (SOHO) 2025 Annual Meeting in Houston, TX [1]. Epcoritamab is a subcutaneous CD3 × CD20 bispecific antibody approved in the US, EU, and Japan for R/R FL based on earlier expansion cohort results. The new analysis included 149 patients pooled from NHL-1 (N=128) and NHL-3 (N=21), with a median follow-up of 35 months, as well as 86 patients treated in an optimisation cohort (OPT) designed to refine cycle 1 dosing, with a median follow-up of 15.5 months.

In the pooled expansion cohorts, the overall response rate (ORR) was 84.6% and the complete response rate (CRR) was 67.1%. Median duration of complete response was not reached. In the OPT cohort, ORR and CRR were even higher at 91.9% and 73.3%, respectively.

Safety was consistent with previous reports and largely manageable. In the expansion cohorts, grade 3-4 infections occurred in 34.9% of patients, including 18.1% with COVID-19, and grade 5 events in 7.4% (5.4% COVID-19). Infections remained a concern with long-term therapy, with grade ≥3 infections reported in 14.3% of patients treated for ≥2 years. In the OPT cohort, grade 3-4 infections were reported in 20.9% of patients, including 7.0% COVID-19. One patient experienced a grade 5 viral respiratory tract infection.

Cytokine release syndrome (CRS) remained low grade and manageable in the OPT cohort, with 39.5% grade 1 and 9.3% grade 2 events. No cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.

These data confirm that epcoritamab induces high and durable response rates with long-term follow-up in a large and diverse global FL population. The absence of new safety signals after 3 years reinforces the role of epcoritamab as a key treatment option for patients with R/R FL.

Karimi Y, et al. Epcoritamab Monotherapy Demonstrates Deep and Durable Responses at 3-Year Follow-Up in Patients With Relapsed/Refractory Follicular Lymphoma. Abstract IBCL-378, SOHO 2025, 2- 7 September 2025.

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