Study summary

Adding retifanlimab to chemotherapy extended survival in advanced anal cancer

POD1UM-303 trial · 308 people in Europe, Australia, Japan, the UK and US · Final survival results May 2026, Annals of Oncology; FDA approval May 2025

32.8 vs 22.2months median survival, retifanlimab vs placebo

What was tested

Retifanlimab, an immunotherapy, or placebo, added to carboplatin and paclitaxel chemotherapy as first treatment for anal cancer that has spread or come back and cannot be removed.

What they found

Median survival was 32.8 months with retifanlimab and 22.2 months with placebo.
Tumors shrank in 56.5% vs 44.8%.
Half of the placebo group later switched to retifanlimab, which makes the survival gap harder to measure; results held after adjusting for this.

What it means

The first immunotherapy approved as first treatment for advanced anal cancer, in May 2025.

Ann Oncol, via PubMed ↗ ← Back to the outlook

Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.