Genmab

Janssen-Cilag announces TECVAYLI® (teclistamab) data from MajesTEC-5 and MajesTEC-4 studies, showing 100% MRD negativity in newly diagnosed multiple myeloma patients, presented at 2024 ASH Annual Meeting.

Johnson & Johnson announces TECVAYLI® (teclistamab-cqyv) data showing 100% MRD negativity in newly diagnosed multiple myeloma patients treated with MajesTEC-5 induction and MajesTEC-4 maintenance therapies, presented at the 2024 ASH Annual Meeting.

DARZALEX FASPRO significantly delayed progression from high-risk SMM to active MM and extended overall survival in Phase 3 AQUILA study, presented at 2024 ASH Annual Meeting.

Preliminary EPCORE® CLL-1 trial data shows epcoritamab monotherapy achieving 61% overall response rate (ORR) and 39% complete response (CR) rate in heavily pretreated relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) patients, with 75% of evaluable responders achieving undetectable minimal residual disease (MRD).

In the EXP cohort, median time to response was 2 months, and median time to CR was 5.6 months. Median PFS was 12.8 months, and median OS was not reached (median follow-up 22.8 months). 65% of patients were alive at 15 months. 75% of 12 responders had undetectable MRD. Common non-hematologic TEAEs included CRS (96%), diarrhea (48%), and fatigue (43%). Cytopenias were common, but largely disease-related. Four fatal TEAEs occurred. The OPT cohort showed reduced CRS severity. High response rates were observed in patients with high-risk factors treated with epcoritamab.

Genmab's Phase 1b/2 EPCORE CLL-1 trial of epcoritamab in relapsed/refractory CLL showed 61% ORR and 39% CR, with 75% of evaluable responders achieving undetectable MRD. Median PFS was 12.8 months, and 65% of patients were alive at 15 months. The most common side effect was CRS (96%). High-risk patients, including those with TP53 aberrations and IGHV-unmutated disease, had encouraging response rates.

EPCORE® CLL-1 trial shows 61% ORR and 39% CR in R/R CLL patients treated with epcoritamab monotherapy, with 75% achieving undetectable MRD. Data presented at ASH 2024.

New results from the Phase 1b/2 EPCORE NHL-2 trial show 96% overall response rate, 87% complete response, and 80% 21-month progression-free survival in patients with relapsed or refractory follicular lymphoma treated with epcoritamab plus lenalidomide + rituximab (R2). The study also reported a two-year overall survival rate of 90%. These findings support the ongoing Phase 3 EPCORE FL-1 trial and follow the recent breakthrough therapy designation granted by the FDA.