Incyte Announces Outcome of FDA Oncologic Drugs Advisory Committee (ODAC) Meeting Reviewing Retifanlimab as a Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

Incyte (Nasdaq:INCY) today announced the outcome of a meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which reviewed the 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. The Committee voted 13-4 that a regulatory decision on retifanlimab for the treatment of advanced or metastatic SCAC should be deferred until further data are available from clinical trial POD1UM-303, a confirmatory trial in platinum-naïve advanced SCAC that is currently underway.

The ODAC provides the FDA with independent opinions and recommendations from outside experts on marketed and investigational medical health supplies for use in the treatment of cancer. The FDA considers the advice of the ODAC in its review but is not bound to follow its recommendations.

"While we are disappointed by the outcome of today's ODAC vote, we will continue to work closely with the FDA as it completes its review of the BLA for retifanlimab," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "Patients with advanced SCAC who have progressed after first-line platinum-based chemotherapy currently have no FDA-approved treatments available to them and face an extremely poor prognosis. We continue to believe that retifanlimab can provide an additional, much-needed option for these patients based on the favorable benefit/risk shown in our trial."

The BLA for retifanlimab is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in 94 previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, platinum-based chemotherapy. The FDA previously granted retifanlimab Orphan Drug Designation for the treatment of anal cancer, along with Priority Review, and set the Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab as July 25, 2021.

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

About POD1UM-202

POD1UM-202 (NCT03597295) is an open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in 94 patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or were ineligible for or intolerant of, platinum-based chemotherapy. Retifanlimab 500mg is administered as an intravenous infusion every 4 weeks for up to 2 years.

The primary endpoint was overall response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.