FDA finds Replimune's melanoma data package uninterpretable, foreshadows tough advisory committee review

The FDA has deemed the single-arm mid-stage study submitted by Replimune for its oncolytic immunotherapy RP1 as not interpretable, raising concerns ahead of an upcoming advisory committee meeting.

The therapy RP1 is being evaluated for accelerated approval in combination with Bristol Myers Squibb's PD-1 inhibitor Opdivo for adults with unresectable advanced cutaneous melanoma who have progressed after prior PD-1 therapy. The FDA previously rejected RP1 twice and accepted a resubmission in June, promising a decision by early August.

FDA reviewers highlighted that the response assessment used in the Phase 1/2 IGNYTE study confounds interpretation of efficacy results, limiting the agency's ability to verify the data. The agency has scheduled a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee to discuss the submission.

The agency's stance follows a similar recent questioning of Capricor's Duchenne muscular dystrophy cell therapy trial, indicating heightened scrutiny of advanced therapy data packages.