Replimune issued Complete Response Letter for RP1 for advanced melanoma

In a Complete Response Letter addressed to Replimune (REPL) dated April 10 posted to the site of the FDA, the agency stated: “We have completed a comprehensive review of all the submissions relating to this BLA for vusolimogene oderparepvec in combination with nivolumab for adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based therapy. We performed a reanalysis of data from study RPL-001-16 along with the review of additional data from study RP1-104. To maintain objectivity and account for potential bias, the review team members for this BLA resubmission were different than those who reviewed the initial BLA. This BLA resubmission primary clinical review team, supervisory leadership in the Office of Therapeutic Products, and subject matter experts from Oncology Center of Excellence unanimously determined data presented are insufficient to conclude substantial evidence of effectiveness of vusolimogene oderparepvec for treatment of unresectable advanced cutaneous melanoma… Therefore, the evidence as presented does not meet the evidentiary standards required for regulatory approval, and the results of the additional exploratory analyses of the RPL-001-16 data do not alter our initial conclusion that the RPL-001-16 trial is not an adequate and well-controlled clinical investigation that demonstrates substantial evidence of effectiveness.”