Sheela Rao, MDS Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust discusses Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC).
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WILMINGTON, Del.—(BUSINESS WIRE)—According to Incyte (Nasdaq: INCY) today, the U.S. The Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for Priority Review as a possible treatment for adult patients with locally advanced or metastatic anal canal squamous cell carcinoma (SCAC) who have advanced or are intolerant to platinum-based chemotherapy.
BLA submissions are based on evidence from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated locally advanced or metastatic SCAC patients who have progressed to or are intolerant to, standard platinum-based chemotherapy. 94 patients, including some with well-controlled human immunodeficiency virus (HIV) infection, were enrolled in the study. The research, recently presented at the Virtual Congress 2020 of the European Society for Medical Oncology (ESMO), resulted in a 14 percent objective response rate (ORR) for retifanlimab monotherapy as calculated by an independent central review (ICR) using RECIST v1.1. Responses were observed irrespective of PD-L1 status, liver metastases, age, or HIV+ status, and were long-lasting (median 9.5 months). Grade 3 adverse effects associated with treatment occurred in 11.7 percent of patients. Grade 3 immune-related adverse reactions in 6.4 percent of patients occurred. Fatigue and diarrhea were the most common adverse reactions (incidence ~ 20 percent).
Retifanlimab has been awarded the FDA Orphan Drug Status, along with the Priority Review, for the treatment of anal cancer. Priority Review is given by the FDA to medicines that could deliver a significant advance in therapy where none currently exists. Compared to the Regular Evaluation, this designation shortens the review duration by four months. Retifanlimab's target action date for the Prescription Drug User Fee Act (PDUFA) is July 25, 2021.
SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for approximately 3% of cancers of the digestive system.1 Metastatic SCAC patients have low 5-year survival, and patients who have progressed following first-line chemotherapy do not have FDA-approved treatments.
A Phase 3 trial of retifanlimab in combination with carboplatin and paclitaxel in patients with inoperable locally recurrent or metastatic SCAC, POD1UM-303/InterAACT 2 (NCT04472429), is now open and is recruiting patients.