System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Publications

Journal Article Ahead of print

PubMed: 42097353 DOI: 10.1016/j.annonc.2026.04.016

Survival outcomes in POD1UM-303/InterAACT-2: a phase 3 study of retifanlimab plus carboplatin-paclitaxel in first-line advanced squamous anal cancer.

Ann Oncol

Authors: S Rao, E Samalin-Scalzi, L Evesque, M Ben Abdelghani, F Morano, A Roy, L Dahan, S Tamberi, A S Dhadda, M G Zampino, N Casanova, R Guimbaud, A Lievre, J Maurel, P Zhang, M C Munteanu, M Jones, C de la Fouchardiere, A Takashima, M Fakih, J Spano

Affiliations

  • Gastrointestinal Unit, Royal Marsden Hospital NHS Foundation Trust, Sutton, Surrey, UK.
  • Department of Medical Oncology, Institut Régional du Cancer de Montpellier, 34090 Montpellier, France.
  • Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
  • Department of Oncology, Centre Paul Strauss, 67100 Strasbourg, France.
  • Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
  • Flinders Medical Centre, Flinders University, Bedford Park, Adelaide, South Australia, Australia.
  • Department of Digestive Oncology, Hôpital de la Timone, Marseille, France.
  • Oncology Unit, Santa Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy.
  • Queens Centre for Oncology and Haematology, Castle Hill Hospital, Cottingham, UK.
  • Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors European Institute of Oncology, IEO, IRCCS, Milan, Italy.
  • Oncology Department, Leeds Cancer Centre, Leeds, UK.
  • Digestive Medical Unit, CHU de Toulouse, Toulouse, France.
  • Department of Gastroenterology, CHU Rennes - Hôpital Pontchaillou, 35000 Rennes, France.
  • Medical Oncology Department, Hospital Clinic de Barcelona, CIBEREHD, Barcelona, Spain.
  • Incyte Corporation, Wilmington, DE, USA.
  • Medical Oncology Department, Centre Léon Bérard, Lyon, France.
  • Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
  • Department of Medical Oncology & Therapeutics Research, City of Hope National Medical Center, Duarte, CA, USA.
  • Department of Medical Oncology, Groupe Hospitalier Pitie-Salpetriere, IUC, APHP Sorbonne University, Paris, France.

Abstract

BACKGROUND

In the primary analysis of the POD1UM-303/InterAACT 2 trial, median progression-free survival (PFS) was significantly longer with retifanlimab plus carboplatin-paclitaxel than with placebo plus carboplatin-paclitaxel in adult, systemic treatment-naïve patients with advanced/metastatic squamous cell carcinoma of the anal canal (SCAC). Here, the final overall survival (OS) data from PODIUM-303/InterAACT 2, along with subgroup and exploratory analyses, are presented.

PATIENTS AND METHODS

POD1UM-303/InterAACT-2 was a phase 3, randomized, double-blind, controlled, multicenter trial with an optional crossover period undertaken in Europe, Australia, Japan, the UK, and the US. The primary endpoint was PFS, and OS was the key secondary endpoint. Other endpoints included response, safety, and exploratory subgroup analyses.

RESULTS

A total of 308 patients were randomized (n = 154 for each of the retifanlimab + carboplatin-paclitaxel and placebo + carboplatin-paclitaxel groups), and 77 patients in the placebo plus carboplatin-paclitaxel group crossed over to receive retifanlimab monotherapy. When retifanlimab plus carboplatin-paclitaxel was compared with placebo plus carboplatin-paclitaxel in the updated efficacy analysis, there was a continued PFS benefit (hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.47-0.81; nominal P = 0.0002) and a consistent and clinically meaningful improvement in OS (HR 0.75, 95% CI 0.55-1.01; P = 0.0305); median OS was 32.8 versus 22.2 months. Overall response rate was 56.5% versus 44.8%, and disease control rates were 87.7% versus 80.5%. The results of the crossover-adjusted analysis were consistent with the main analysis, and there was a consistent OS benefit in favor of retifanlimab plus carboplatin-paclitaxel in all subgroups analyzed. No new safety signals or trends were reported.

CONCLUSION

This final analysis confirms the benefits of retifanlimab plus chemotherapy in SCAC. The results suggest that retifanlimab represents a new reference treatment and standard of care for patients with inoperable, locally recurrent or metastatic SCAC.

MeSH

Safety, Paclitaxel, Anus Neoplasms, Neoplasms, Immunotherapy, Therapeutics, Carboplatin