Lance Leopold, MD, Group Vice President, Immuno-Oncology, at Incyte, discusses the clinical trial of retifanlimab for the treatment of squamous cell carcinoma of the anal canal (SCAC).

SCAC is a rare cancer in which malignant cells form in the cells that line the anus. This is the most common type of anal cancer. Risk factors for SCAC include human papillomavirus infection, a history of sexually transmitted diseases, a history of vulvar or cervical carcinoma, immunosuppression related to human immunodeficiency virus (HIV) infection or after organ transplantation, hematological or immunological disorders, and smoking. 

PODIUM-202 is an open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. As Dr. Leopold explains, a number of the trial’s participants have well-controlled HIV infection. The results of the study demonstrated an objective response rate (ORR) of 14% for retifanlimab monotherapy. ORR is the study’s primary endpoint. Additionally, the results of the study highlighted retifanlimab’s durable response and minimal severe treatment-related adverse events. 

These promising results supported Incyte’s Biologics License Application (BLA) submission for retifanlimab for the treatment of squamous cell carcinoma of the anal canal (SCAC) as well as the decision of the U.S. Food and Drug Administration (FDA) to accept and announce Priority Review on Inctye’s BLA. The Prescription Drug User Fee Act (PDUFA) target date for retifanlimab is July 25, 2021.

For more information about SCAC and other rare cancers, visit