odronextamab DLBCL - Regeneron touts Phase II data for bispecific antibody ahead of FDA approval

The FDA has set a Prescription Drug User Fee Act (PDUFA) date for odronextamab in diffuse large B-cell lymphoma and follicular lymphoma on 31 March 2024.

Regeneron Pharmaceuticals has presented positive data for odronextamab from Phase I ELM-1 and Phase II ELM-2 trials at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, US, from 9 to 12 December.

Odronextamab is a CD20xCD3 targeting bispecific antibody which is currently being evaluated by the US Food and Drug Administration (FDA) as a treatment for relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and r/r follicular lymphoma (FL). The agency has set a PDUFA date for odronextamab on 31 March 2024.

Regeneron has also disclosed updated Phase I/II LINKER-MM trial data for linvoseltamab as a treatment for r/r multiple myeloma (MM). Linvoseltamab is a B-cell maturation antigen (BCMA) and CD3-targeting bispecific antibody.

At eight months follow-up, the median duration of response (DoR) and median progression-free survival (PFS) have not been reached, said Dr. Hans Lee, LINKER-MM trial investigator, in an interview with Clinical Trials Arena.

Odronextamab trial data

The open-label Phase II ELM-2 trial (NCT03888105) investigating odronextamab enrolled patients with B-cell non-Hodgkin lymphoma who have received at least two prior lines of systemic therapy. The objective response rate (ORR) of 52% was observed in the 127 patients enrolled in the DLBCL cohort at 36 weeks of follow-up. The DoR was ten months, with 31% of the participants achieving complete response (CR).

The prespecified interim analysis occurred when the first 80 patients had at least 12 months of follow-up. The data showed an ORR of 80% among 128 patients in the FL cohort and DoR was 23 months, with 73% of the participants achieving CR.