In this phase 3 randomized trial of patients with advanced squamous cell carcinoma of the anal canal, retifanlimab combined with carboplatin-paclitaxel significantly improved progression-free survival, overall survival, and response rates compared to chemotherapy alone. Crossover-adjusted analyses confirmed the robustness of the overall survival benefit. The safety profile was manageable with no new safety signals identified, supporting retifanlimab plus chemotherapy as a new standard of care in this setting.
Study
|
Phase 3, randomized, double-blind, controlled, multicenter trial [POD1UM-303/InterAACT-2] |
| Inoperable anal SCC |
| Retifanlimab + carboplatin-paclitaxel (CP+R, n=154) vs placebo + carboplatin-paclitaxel (CP + placebo, n=154), with crossover allowed for placebo arm to retifanlimab monotherapy
|
Efficacy
|
ORR: 56.5% vs 44.8% (CP+R vs. CP + placebo) (P = 0.0138) |
| DCR: 87.7% vs 80.5% |
| mPFS: 9.3 mos vs 7.4 mos (HR 0.62 [0.47-0.81]) |
| mOS: 32.8 mos vs 22.2 mos (HR 0.75 [0.55-1.01]) |
| 36-mo OS rate: 47.5% vs 34.3%
|
Safety
|
Treatment discontinuation due to AEs: 11.7% vs 2.6%
|
Ann Oncol 2026. Published online 2026-04-27
http://doi.org/10.1016/j.annonc.2026.04.016
Reviewed by Ulas D. Bayraktar, MD on May 15, 2026
