# POD1UM-303/InterAACT-2: retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic anal squamous cell carcinoma

Source: https://onco.cc/key-papers/paper-pod1um-303-retifanlimab-anal-cancer-rao-lancet-2025/  
OnCo record `paper-pod1um-303-retifanlimab-anal-cancer-rao-lancet-2025` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the PD-1 antibody retifanlimab to first-line carboplatin and paclitaxel for advanced anal cancer lengthened the time before the cancer progressed from 7.4 to 9.3 months and cut the risk of progression by 37 percent, with manageable extra toxicity.

## Summary

Global double-blind randomised phase 3 trial: 308 patients with untreated inoperable locally recurrent or metastatic anal squamous cell carcinoma were randomised to carboplatin-paclitaxel with retifanlimab (154) or placebo (154).

Median progression-free survival was 9.3 months with retifanlimab against 7.4 months with placebo (hazard ratio 0.63, one-sided p 0.0006). Serious adverse events (47.4 against 38.8 percent) and grade 3 or worse adverse events (83.1 against 75.0 percent) were more frequent with retifanlimab; neutropenia and anaemia were the most common. One treatment-related fatal event (pancytopenia) occurred in the retifanlimab group.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Journal: The Lancet
- Year: 2025
- DOI: 10.1016/S0140-6736(25)00631-2
- Authors: Rao S, Samalin-Scalzi E, Evesque L, et al.
- Findings: Median progression-free survival 9.3 months (95% CI 7.5 to 11.3) versus 7.4 months (7.1 to 7.7); hazard ratio 0.63 (0.47 to 0.84), one-sided p 0.0006.; Serious adverse events 47.4 versus 38.8 percent; grade 3 or worse adverse events 83.1 versus 75.0 percent.; Grade 3 or worse neutropenia 35.1 versus 29.6 percent; anaemia 19.5 versus 20.4 percent.
- What it means: Retifanlimab with carboplatin-paclitaxel is the new first-line standard for advanced anal squamous cell carcinoma; approved in the United States in May 2025.
- Caveats: Overall survival was immature at publication.; Funded and run by the manufacturer.

## Sources

- Lancet 2025: https://doi.org/10.1016/S0140-6736(25)00631-2
- PubMed: https://pubmed.ncbi.nlm.nih.gov/40517007/

## Connected records

- cancers: [Anal cancer (squamous cell carcinoma)](https://onco.cc/cancers/anal/), [Metastatic and recurrent anal squamous cell carcinoma](https://onco.cc/cancers/metastatic-anal-cancer/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Retifanlimab](https://onco.cc/drugs/retifanlimab/)
- trials: [POD1UM-303/InterAACT-2](https://onco.cc/trials/pod1um-303/)
- journals: [The Lancet](https://onco.cc/journals/lancet/)

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