FDA grants priority review to retifanlimab for anal cancer subset
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The FDA granted priority review to retifanlimab for treatment of certain patients with squamous cell carcinoma of the anal canal, according to the agent’s manufacturer.
The designation applies to use of the agent by adults with locally advanced or metastatic disease who progressed on or were intolerant of standard platinum-based chemotherapy.
Squamous cell carcinoma of the anal canal — associated with HIV and HPV infections — accounts for approximately 3% of digestive system cancers. Patients with metastatic disease have poor 5-year survival outcomes, and no FDA-approved therapies exist for patients who progressed after first-line chemotherapy.
Retifanlimab (Incyte) is a PD-1 inhibitor administered via IV.
The FDA based the priority review on results of the open-label, multicenter, phase 2 PODIUM-202 trial, which included 94 patients with previously treated locally advanced or metastatic squamous cell carcinoma of the anal canal. All patients progressed on or were intolerant of platinum-based chemotherapy, and several had well-controlled HIV infection.
Patients received retifanlimab dosed at 500 mg via IV every 4 weeks. Objective response rate assessed by independent central review served as the primary endpoint.
Researchers reported an ORR of 14%, with a 9.5-month median duration of response. Responses occurred regardless of HIV status, age, PD-L1 status or presence of liver metastases.
The most common adverse events were fatigue and diarrhea; 11.7% of patients experienced grade 3 or higher treatment-related adverse events and 6.4% of patients experienced grade 3 or higher immune-related adverse events.
“Patients with [squamous cell carcinoma of the anal canal] who have progressed after first-line chemotherapy treatment currently have no approved treatments available, and we are encouraged that the FDA’s acceptance of this [biologics license application] for priority review brings us one step closer to addressing this historically neglected yet important tumor,” Lance Leopold, MD, group vice president for immuno-oncology development with Incyte, said in a company-issued press release.
The FDA previously granted orphan drug designation to retifanlimab for treatment of anal cancer. The agency is expected to make a decision on approval of the therapy by July 25.
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