Genmab A/S (NASDAQ:GMAB) and AbbVie Inc (NYSE:ABBV) announced topline results from the first cohort of the EPCORE NHL-1 phase 1/2 trial of epcoritamab (DuoBody-CD3xCD20).
- Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab's DuoBody technology designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells.
- The study cohort includes 157 patients with relapsed/refractory large B-cell lymphoma (LBCL) who received at least two prior lines of systemic therapy.
- LBCL is a type of non-Hodgkin's lymphoma (NHL), cancer that develops in the lymphatic system affecting B-cell lymphocytes, a type of white blood cell.
- The topline results demonstrated an overall response rate (ORR) of 63.1%, exceeding the protocol prespecified efficacy threshold.
- 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 companies will engage global regulatory authorities to determine the next steps based on the topline results.
- Last month, the FDA granted Orphan Drug designation to epcoritamab for follicular lymphoma (FL).
- Price Action: ABBV shares are down 0.48% at $158.18, and GMAB is down 2.83% at $36.05 during the premarket session on the last check Thursday.
