Genmab reports new data from Phase 1b/2 EPCORE CLL-1 trial

Genmab (GMAB) announced new and updated data from three arms of the ongoing Phase 1b/2 EPCORE CLL-1 trial evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination for the treatment of patients with Richter transformation, a rare complication in which chronic lymphocytic leukemia evolves into an aggressive lymphoma, most often diffuse large B-cell lymphoma. The results were presented in two oral presentations (abstracts 1015 and 1017) at the 67th Annual Meeting and Exposition of the American Society of Hematology, in Orlando, Florida. In Arm 2A of the trial, patients with RT received epcoritamab monotherapy in the first-line setting or in second- or later-line settings, with a median follow-up of 22.9 months. In the first-line setting, patients achieved an overall response rate of 57%, with 52% experiencing a complete response. The median overall survival was 27.5 months, progression-free survival was 8.5 months, and the median duration of response and duration of complete response were not reached. Among RT patients who received epcoritamab monotherapy in second- or third-line settings, ORR was 38% and the CR rate was 29%. The median DOR was 6.6 months, median PFS was 2.9 months, and median OS was 9.8 months. The results from Arm 2A have been simultaneously published in The Lancet Haematology. In Arm 2B, previously-treated patients with RT ineligible to receive chemoimmunotherapy who had two or less prior lines of therapy received epcoritamab in combination with lenalidomide. With a median follow-up of 16.7 months, the ORR was 82% and the CR rate was 73%. The median OS at nine months was not reached, and the median PFS was 5.7 months. The estimated median DOR and DOCR were not reached. In this arm of the trial, CRS events were primarily low grade and resolved in 10 patients, with a median time to resolution of four days. One patient discontinued due to CRS. ICANS occurred in two patients and resolved in a median of 2.5 days. There was one treatment-related Grade 5 event.