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On Wednesday, the FDA approved Epkinly (epcoritamab-bysp) as the first and only T-cell-engaging bispecific antibody administered subcutaneously for adults with relapsed or refractory follicular lymphoma (r/r F) after two or more lines of prior therapy.
Epcoritamab is being co-developed by AbbVie Inc. (NYSE:ABBV) and Genmab A/S (NASDAQ:GMAB) as part of their oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
The indication is approved under the FDA’s Accelerated Approval program based on overall response rate (ORR) and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
About 15,000 people develop FL each year in the U.S., and it is considered incurable with current standard-of-care therapies.
FDA approval is based on Phase 1/2 EPCORE NHL-1 clinical trial results. The study results showed an ORR – the study’s primary endpoint − of 82%, a complete response (CR) rate of 60%, and a partial response (PR) rate of 22%.
At a median follow-up of 14.8 months among responders, more than half of the patients who responded to treatment in the study remained responsive to treatment (i.e., the median duration of response was not reached).
A separate dose optimization cohort evaluated 86 patients at the recommended 3-step dosage schedule for CRS mitigation.
The first full dose of this 3-step regimen did not require mandatory hospitalization. No grade 3 CRS was observed in patients with FL who received EPKINLY with the 3-step-up dosage schedule.
William Blair writes that the approval supports Epkinly’s long-term growth potential. Expansion opportunities in additional indications and earlier lines of lymphoma treatment are underway and recent data at ASCO and EHA have shown encouraging results.
The analyst highlights that Epkinly’s market potential is constrained by its limited application to later-line lymphoma and Roche Holdings AG’s (OTC:RHHBY) Lunsumio’s first-mover advantage in similar outpatient settings.
William Blair maintains a Market Perform rating for Epkinly, awaiting further indication expansion and clinical updates from its pipeline, including new data for BioNTech SE’s (NASDAQ:BNTX) acasunlimab and comparative data with GEN3014 against Johnson & Johnson’s (NYSE:JNJ) Darzalex expected later this year.
Price Action: GMAB shares are down 0.31% at $25.59, and ABBV shares are down 1.57% at $168.47 at the last check on Thursday.
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