FDA Grants Priority Review to Epcoritamab for Relapsed/Refractory LBCL

Patients with relapsed/refractory large B-cell lymphoma may benefit from epcoritamab, which received priority review from the FDA.

The FDA has granted priority review for the biologics license application (BLA) of epcoritamab (DuoBody®-CD3xCD20) as a treatment for patients with relapsed/refractory large B-cell lymphoma (LBCL) after 2 or more lines of therapy, according to a press release from Genmab.

The application is supported by findings from the LBCL cohort of the phase 1/2 EPCORE NHL-1 trial (NCT03625037) which assessed epcoritamab in a population with relapsed, progressive, or refractory CD20-positive mature B-cell non-Hodgkin lymphoma. Topline data from the trial indicated that patients experienced an overall response rate of 63.1% by independent review committee with a median duration of response of 12 months. There were few incidences of high-grade cytokine release syndrome, with 49.7% of patients experiencing the toxicity in total.2

The FDA has set a prescription drug user fee act date of May 21, 2023.

“We are pleased that the BLA for epcoritamab has been accepted for priority review by the FDA, accelerating the pathway for approval and bringing us one step closer to potentially delivering a novel treatment option to [patients with] relapsed and refractory LBCL who are in need of additional treatment options,” Jan van de Winkel, PhD, chief executive officer at Genmab, said in the press release. “…We recognize the unmet need for safe, effective, and accessible treatments for patients with B-cell malignancies and we believe that epcoritamab has the potential to become a core therapy in this patient population.”

The phase 1/2 study assessed single-agent epcoritamab administered by subcutaneous injection as part of a 28-day cycle.

The primary end points were dose-limiting toxicities, incidence of adverse effects, and overall response rate, and secondary end points included duration of response, time to response, progression-free survival, overall survival, and minimal residual disease rate/duration.

Patients with CD20-positive non-Hodgkin lymphoma were required to be 18 years or older with measurable disease and a ECOG performance status of 0 to 2. Acceptable organ function at screening was also required. Patients who received chemotherapy, radiation, or major surgery within 4 weeks of their first dose of epcoritamab; prior treatment with a bispecific targeting CD3 or CD20; or who underwent CAR T-cell therapy within 30 days were not eligible to enroll on the trial. Other exclusion criteria included having clinically significant cardiovascular disease, central nervous system involvement, or evidence of a notable, uncontrolled concomitant disease that could impact compliance.

A BLA was submitted to the FDA and a marketing authorization application for epcoritamab were submitted to the FDA and European Medicines Agency, respectively in October 2022. Both applications were based on the phase1/2 EPCORE NHL-1 study. In addition to being evaluated in LBCL, epcoritamab is being assessed in a population of patients with relapsed/refractory follicular lymphoma as part of the phase 3 EPCORE FL-1 study (NCT05409066).

References

  1. Genmab announces U.S. Food and Drug administration accepts for priority review biologics license application (BLA) for epcoritamab (DuoBody®-CD3xCD20) for the treatment of relapsed/refractory large B-cell lymphoma (LBCL). News release. Genmab. November 21, 2022. Accessed November 21, 2022. http://bit.ly/3tNeMhT
  2. Genmab announces late-breaking phase 2 trial results of investigational epcoritamab (DuoBody®-CD3xCD20) in relapsed/refractory large B-cell lymphoma (LBCL) presented at European Hematology Association (EHA) Presidential Symposium. News release. Genmab. June 11, 2022. Accessed November 21, 2022. http://bit.ly/3EPMREh