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by Dr. C.H. Weaver M.D. 1/2021

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.

Squamous cell carcinoma of the anal canal is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers. Patients with advanced SCAC have a poor 5-year survival, and there are no FDA-approved treatments for patients who have progressed after first-line chemotherapy. (1,2)

About Retifanlimab

Retifanlimab (formerly INCMGA0012) is an investigational intravenous anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and 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 for the treatment of anal cancer.

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About POD1UM-202

POD1UM-202 is a clinical trial evaluating retifanlimab in patients with squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. Retifanlimab 500 mg is administered intravenously every 4 weeks. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection and has initially reported overall response rate of 14% with a median response duration of 9.5 months. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status.

Retifanlimab has been granted Orphan Drug Designation by the FDA for the treatment of anal cancer, along with Priority Review. The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period by four months as compared to Standard Review.

References

  1. Ghosn M, et.al. Anal cancer treatment: current status and future perspectives. World J Gastroenterol 2015;21:2294-2302.
  2. Eng C, et al. The role of systemic chemotherapy and multidisciplinary management in improving the overall survival of patients with metastatic squamous cell carcinoma of the anal canal. Oncotarget 2014;5:11133-11142.