Genmab/AbbVie's Blood Cancer Treatment Shows 82% Response Rate In Pretreated Follicular Lymphoma Patients

Genmab A/S GMAB and AbbVie Inc ABBV have announced topline results from the follicular lymphoma (FL) cohort of the phase 1/2 EPCORE NHL-1 clinical trial evaluating epcoritamab (DuoBody CD3xCD20), an investigational T-cell engaging bispecific antibody administered subcutaneously. 

The study cohort includes 128 adult patients with relapsed/refractory follicular lymphoma (FL) who received at least two prior lines of systemic therapy. 

70.3% of patients were double refractory to an anti-CD20 monoclonal antibody and an alkylating agent. 

The topline results from this cohort showed an overall response rate (ORR) of 82%, as confirmed by an independent review committee, which exceeded the protocol-prespecified threshold for efficacy.

The observed median duration of response (DOR) was not reached. No new safety signals were observed with epcoritamab in this study at the time of analysis. 

The most common treatment-emergent adverse event was cytokine release syndrome (CRS), with 66.4% (1.6% grade >2). 

Aligned with the FDA's Project Optimus, the optimization part of the trial is continuing to evaluate alternative step-up dosing regimens to mitigate the risk of CRS; preliminary data on the initial patients enrolled indicate a clinically meaningful improvement in CRS rate. 

Based on the topline results, the companies will engage with global regulatory authorities to determine the next steps. 

In May, the FDA approved Epkinly (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Price Action: ABBV shares are up 0.54% at $133.32 during the premarket session on the last check Wednesday. GMAB shares closed at $37.56 on Tuesday.