Regeneron’s lung cancer Lag3 lag

Regeneron is already behind its big Lag3 rivals, and the company had bad news this week with a delay to its hopeful fianlimab in first-line NSCLC. Two phase 2/3 studies had been due to yield phase 2 data by the end of 2024, but Regeneron said in its JP Morgan presentation that the results would now come in the first half of 2025. Lag3 projects have disappointed in NSCLC, although this hasn’t stopped Bristol Myers Squibb from pushing into phase 3 with Opdualag. At least pivotal data with fianlimab in first-line melanoma, potentially its first approved use, continue to be expected in the second half – although these had once also been due in 2024. Regeneron had better news with its T-cell engagers odronextamab and linvoseltamab, which both received CRLs last year. Linvoseltamab, which was knocked back on third-party manufacturing issues, has already been resubmitted, with a decision expected by mid-2025. Meanwhile odronextamab, which was rejected because its confirmatory trials were still in their dose-finding stages, is set for refiling in the first quarter. However, Regeneron originally sought odronextamab approval in late-line follicular and diffuse large B-cell lymphomas, while the JP Morgan presentation only mentions a follicular lymphoma resubmission.

Selected upcoming Regeneron oncology milestones

Source: company presentation.