Regeneron Presents Positive Phase II Results for its Lymphoma Drug

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Pictured: Regeneron logo on a light brown building/Shutterstock, Lev Radin

Regeneron has lifted the curtain on Phase II data for odronextamab, which it is investigating in patients with relapsed/refractory follicular lymphoma.

Regeneron’s investigational CD20xCD3 bispecific antibody results were announced Sunday at the American Society of Hematology annual meeting.

Regeneron said the longer-term data from the Phase II trial showed that the drug “continued to confirm high rates of durable responses” in lymphoma patients. Of the 128 patients assessed in the trial, 80% achieved an objective response, while 73% had a complete response.

The median duration of a response was 23 months, with the median time of a complete response was 24 months. The average progression-free survival for those with a complete response was recorded at 28 months. However, Regeneron noted that the median overall survival was not reached.

“The odronextamab data presented at ASH in patients with relapsed/refractory follicular lymphoma showcase a strong profile across measures of efficacy, safety and health-related quality of life,” Benoît Tessoulin, a trial investigator at Nantes University Hospital, said in Regeneron’s press release. “For odronextamab, it is particularly encouraging to see the unprecedented clinical results complemented by patient-reported outcomes that show quality of life and functional measures are maintained overall.”

The drug is currently being undertaken for priority review for both relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) by the FDA. The agency has set a target action date for both indications of March 31, 2024. Odronextamab also has a fast-track designation by the FDA and an orphan drug designation by the EMA.

In December of last year, Regeneron posted trial results of the drug in patients with relapsed/refractory DLBCL, including patients naive to CAR-T therapy. Those results showed a 49% objective response rate, with 31% having a complete response. Post–CAR T patients had a 48% overall response rate, with 32% having a complete response.

Last week, Regeneron posted positive data from its multiple myeloma drug, linvoseltamab, with nearly half of the patients getting a complete response or better and 71% having an objective response rate. However, 85% of patients had Grade 3 or higher adverse events, with 14 patients dying due to treatment-emergent adverse events.  

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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