ASH: Regeneron’s ELM stands tall, with near-approval bispecific shining again in updated lymphoma data

Regeneron has brought its bispecific antibody odronextamab through another test, presenting updated data on the lymphoma candidate ahead of an FDA approval decision scheduled for March.

The data come from a phase 2 trial, ELM-2, that enrolled people with various subtypes of B-cell non-Hodgkin lymphoma. One year ago, Regeneron presented data from the diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) cohorts of the trial, linking its CD20xCD3 bispecific to durable responses in many patients.

Over the weekend, Regeneron shared updated data at the American Society of Hematology Annual Meeting. The data are in line with the results shared a year ago.

In DLBCL, Regeneron reported objective and complete response rates (ORR/CR) of 52% and 31%, respectively, compared to 49% and 31% one year ago. The median duration of response was 10 months, rising to 18 months in people who had complete responses. Again, the result is consistent with the data Regeneron shared last year.

The company also shared an update from a cohort of DLBCL patients in the phase 1 ELM-1 study who took odronextamab after progressing on CAR-T therapy. In 44 efficacy-evaluable patients, including 73% who were CAR-T refractory, the ORR and CR were 48% and 30%. The response rates are in line with the data Regeneron shared last year. Regeneron is still yet to reach the median duration of response. 

The picture in FL is similarly consistent with the earlier readout. Regeneron linked its candidate to an 80% ORR and 73% CR in the setting. The ORR and CR figures shared last year were 82% and 75%, respectively. Median progression-free survival in FL was 21 months, up from 20 months last time around, and the trial is still yet to reach median overall survival.

On the safety front, cytokine release syndrome (CRS) again affected around half of the participants in each of the analyses shared by Regeneron. While CRS is common, efforts to prevent serious cases appear to be working. Regeneron reported one grade 3 case of CRS among the 60 patients who received the recommended step-up regimen. Most of the cases were grade 1 and the median duration was two days.

Regeneron is trying to win approval in the U.S. and Europe on the strength of the data. Work to validate the bispecific is continuing, with the big biotech running multiple phase 3 clinical trials of the candidate as a monotherapy and in combination with current standards of care in earlier lines of FL and DLBCL.