Epcoritamab induces response in relapsed/refractory follicular lymphoma
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More than 80% of a cohort of adults with relapsed or refractory follicular lymphoma exhibited an overall response to subcutaneously administered epcoritamab-bysp, according to topline data from the agent’s manufacturer.
Epcoritamab-bysp (Epkinly; Genmab, AbbVie) is an investigational IgG1-bispecific antibody designed to bind to CD3 on T cells and CD20 on B cells simultaneously, while inducing T-cell-mediated killing of CD20-positive cells.
The open-label, multicenter phase 1/2 EPCORE NHL-1 trial assessed the safety and preliminary efficacy of epcoritamab-bysp among patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma through three phases — a phase 1 first-in-human dose escalation phase, a phase 2 escalation phase and an optimization phase.
The study included 128 adults with relapsed/refractory follicular lymphoma who received two or more prior lines of systemic therapy. Among them, 70.3% had double-refractory disease to an anti-CD20 monoclonal antibody and an alkylating agent.
Overall response rate served as the primary endpoint of the expansion phase of the trial, with secondary endpoints of duration of response, complete response rate, duration of complete response, PFS and time to response.
Results showed an ORR of 82% as confirmed by independent review committee, exceeding the protocol prespecified threshold for efficacy.
Median duration of response had not been reached, and researchers detected no new safety signals. The most common treatment-emergent adverse events included cytokine release syndrome (66.4%; 1.6% grade 3 or higher).
“These topline results are encouraging for [patients with] relapsed or refractory follicular lymphoma who are in need of new therapeutic options,” Jan van de Winkel, PhD, CEO of Genmab, said in a release. “With our partner AbbVie, we are committed to evaluating epcoritamab as a potential core therapy across B-cell malignancies. We look forward to sharing the full results from this study cohort at an upcoming medical congress and discussing the results with global regulatory authorities.”
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