Genmab and AbbVie release positive top-line results for epcoritamab

Danish biotech Genmab (Nasdaq: GMAB) and the USA’s AbbVie (NYSE: ABBV) have announced top-line results from the first cohort of the EPCORE NHL-1 Phase I/II, clinical trial evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody.

The top-line results from this cohort demonstrated an overall response rate (ORR) of 63.1% as confirmed by an independent review committee (IRC), which exceeded the protocol prespecified threshold for efficacy. The observed median duration of response (DOR) was 12 months. The most common treatment-emergent adverse event was cytokine release syndrome (CRS) with 49.7%, including 2.5% grade 3. The data will be submitted for presentation at a future medical meeting.

The study cohort includes 157 patients with relapsed/refractory large B-cell lymphoma (LBCL) who received at least two prior lines of systemic therapy, including 38.9% who received prior treatment with chimeric antigen receptor (CAR) T-cell therapy. Based on the top-line results, the companies will engage global regulatory authorities to determine next steps.