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Standard first-line chemotherapy for patients with advanced anal cancer combines carboplatin and paclitaxel. Immune checkpoint inhibitors have been endorsed for later-line therapy based on modest activity in phase 2 trials. Now, investigators report results of a global, placebo-controlled, randomized phase 3 trial of the anti-PD-1 agent retifanlimab plus carboplatin and paclitaxel in patients with advanced or metastatic anal squamous cell cancer. Among 308 participants, 72% were female, 70% had received prior radiotherapy, and 91% tested PD-L1–positive at 1% or higher.
Progression-free survival (the primary endpoint) was superior for the addition of retifanlimab versus placebo (9.3 vs. 7.4 months, HR 0.63). Preliminary analysis of median ove…