Incyte’s retifanlimab meets primary endpoint in carcinoma Phase 3 trial

Incyte (INCY) announced that primary results from the Phase 3 POD1UM-303/InterAACT 2 trial of retifanlimab – Zynyz -, a humanized monoclonal antibody targeting programmed death receptor-1, in combination with carboplatin and paclitaxel in adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal cancer, or SCAC, who have not been previously treated with systemic chemotherapy, were published in The Lancet. The study met its primary endpoint by demonstrating a statistically significant improvement in progression-free survival in patients with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy. Adding retifanlimab to carboplatin and paclitaxel resulted in a clinically meaningful 37% reduction in the risk of progression or death. Patients in the retifanlimab and chemotherapy combination group achieved a median PFS of 9.3 months vs. 7.4 months for patients in the placebo combination group. A consistent benefit in PFS in favor of retifanlimab plus chemotherapy was observed for all pre-defined subgroups with sufficient patients for comparison. A clinically meaningful 6-month difference in overall survival was observed at the interim analysis. Interim OS results were not statistically significant, and patients continue to be followed for the final key secondary OS analysis. Overall response rate to treatment was improved by the addition of retifanlimab to the chemotherapy and the median duration of response was approximately doubled. No new safety signals were observed and safety was consistent with chemotherapy plus checkpoint inhibitor regimens.