Epcoritamab shows promise in treating relapsed/refractory diffuse large B-cell lymphoma.

Genmab announced updated results from the Phase 2 EPCORE NHL-6 trial evaluating the safety and efficacy of epcoritamab, a T-cell engaging bispecific antibody, as a monotherapy in adult patients with relapsed/refractory diffuse large B-cell lymphoma. The trial demonstrated that 92% of patients received the first full dose in an outpatient setting, with an adverse event profile and efficacy consistent with previously reported studies. The overall response rate was 64.3% and complete response rate was 47.6% in patients treated with epcoritamab following one prior line of systemic DLBCL therapy.

Genmab (Nasdaq: GMAB) has announced updated results from the Phase 2 EPCORE® NHL-6 trial, which evaluated the safety and efficacy of epcoritamab, a T-cell engaging bispecific antibody, as a monotherapy in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The trial demonstrated that 92% of patients received the first full dose of epcoritamab in an outpatient setting, with an adverse event profile and efficacy consistent with previously reported studies [1].

The EPCORE NHL-6 trial enrolled 92 patients with R/R DLBCL who had received at least one prior line of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy. The primary objective of the trial was to assess adverse events within three months of treatment initiation with epcoritamab monotherapy. The primary outcome measures were the percentage of participants experiencing Grade 3 or higher cytokine release syndrome (CRS) events, immune cell-associated neurotoxicity syndrome (ICANS) events, and/or neurotoxicity (Ntox) events. Secondary outcomes included responses to treatment [1].

The study demonstrated the feasibility of treating and monitoring patients in an outpatient setting following the first dose of epcoritamab. Among the 81 patients treated and monitored as outpatients, 57 (70%) did not experience cytokine release syndrome (CRS) during the first full dose period. CRS occurred with the first full dose in 24 (30%) patients, all Grade 1–2 events, with 10 (12%) patients managed in the outpatient setting, and 11 (13.6%) requiring inpatient care. Overall, CRS events occurred in 37 (40.2%) patients in the entire trial period, were primarily low grade (Grade 1-2), all resolved with a median time of two days, and no events led to treatment discontinuation. Immune cell-associated neurotoxicity syndrome (ICANS) occurred in seven patients (7.6%), were primarily low grade (Grade 1-2), all resolved with a median time of three days, and no events led to treatment discontinuation [1].

The overall response rate (ORR) was 64.3% and the complete response (CR) rate was 47.6% in patients treated with epcoritamab following one prior line of systemic DLBCL therapy. In patients treated with epcoritamab following two or more lines of systemic therapy, the study showed an ORR of 60.0% and a CR rate of 38.0% [1].

Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer at Genmab, stated, "Together with our partner AbbVie, we remain committed to advancing research that supports people living with blood cancer no matter where they are in their treatment journey and developing epcoritamab as a potential core therapy across B-cell malignancies" [1].

The safety and efficacy of investigational epcoritamab for use in the outpatient setting for the first full dose in R/R DLBCL in the second-line setting have not been approved by the US FDA or any other health authority. Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases [1].

References:
[1] https://finance.yahoo.com/news/genmab-announces-updated-results-phase-123000953.html