Lance Leopold, MD, Group Vice President, Immuno-Oncology, at Incyte, discusses retifanlimab, an investigational treatment for 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. As with many cancers, increased age is also a risk factor.

As Dr. Leopold explains, retifanlimab is an investigational intravenous anti-PD1 antibody currently under evaluation in clinical trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC). It is also being evaluated in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of anal cancer. Recently, the FDA accepted and announced Priority Review on Inctye’s Biologics License Application (BLA) submission based on positive results from the phase 2 PODIUM-202 study. 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