An evaluation of retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal

INTRODUCTION: Anal squamous cell carcinoma (SCC) is a rare cancer. Metastatic anal SCC is still a significant clinical challenge due to limited treatment options and poor outcomes. AREAS COVERED: This review paper will focus on retifanlimab, a humanized monoclonal antibody targeting the programmed cell death protein 1 (PD-1) pathway, and its role in the treatment of metastatic anal SCC, both as monotherapy or in combination with chemotherapy. This review will evaluate its efficacy, safety, and place within the current therapeutic landscape. EXPERT OPINION: The POD1UM-303 trial is the first randomized phase III study for patients with metastatic and locally, advanced unresectable anal SCC. The results from POD1UM-303 are practice-changing, establishing retifanlimab in combination with carboplatin and paclitaxel as a new standard of care for first-line treatment in this setting. Current research includes investigating earlier integration of PD-(L)1 inhibitors with definitive chemoradiotherapy in the locally advanced setting. Further biomarker-driven studies are essential to guide treatment and improve patient selection.