2021-01-25| Trials & Approvals

Another Checkpoint Inhibitor Set to Make Market Appearance as FDA Grants Priority Review

by Ruchi Jhonsa
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The paramount achievement in cancer treatment in the last decade has undoubtedly been the arrival of checkpoint inhibitors that relieve T cells from tumor-mediated suppression. It started with the approval of ipilimumab in 2011, followed by Merck’s blockbuster Keytruda, BMS’s Opdivo, Roche’s Tecentriq AstraZeneca’s Imfinzi. There are seven already in the market, and the eighth is about to make a red carpet appearance.

On January 21st, Delaware-based Incyte announced that the USFDA had accepted their application to review their PD-1 checkpoint inhibitor, retifanlimab, on a priority basis. The drug, which is targeted for a niche indication of anal cancer, is developed for patients who fail to respond to platinum-based chemotherapies. With the speedup review, Incyte is expecting to hear from FDA with the final decision by mid of this year.

“Despite SCAC being a rare disease, its incidence is increasing, and its impact is profound. We look forward to working with the FDA to potentially fill an unmet need and advance progress in SCAC for patients,” said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte.


Phase 2 POD1UM-202 Trial

The company based its application on data from the Phase 2 POD1UM-202 trial that tested the drug on 94 patients, including several with well-controlled HIV infection. Incyte has particularly included HIV-patients in the trial as SCAC is associated with HIV infection. So far, there is no treatment that helps this particular subgroup of HIV-infected patients. The study reported an objective response rate of 14%, progression-free survival of 2.3 months, and overall survival of 10.1 months regardless of patients’ PDL-1 status, presence of liver metastases, age, or HIV positive status. The response stayed on for a median of 9.5 months.

When compared to other checkpoint inhibitors in the market, these values are not very different. Tecentriq showed ORR/PFS of 10%/2.1 months, Keytruda showed ORR/PFS of 17%/3 months, and Opdivo showed ORR/PFS of 24%/4.1 months. While none of these have been approved for anal cancer, they still give a good indication of where retifanlimab stands in their comparison.

In parallel to the POD1UM-202 trial, Incyte began a 300-subject Phase 3 clinical trial in November. The study will show if retifanlimab can work better in combination with IDO1 inhibitor epacadostat and FGFR inhibitor Pemazyre.

“Patients with SCAC 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 BLA for Priority Review brings us one step closer to addressing this historically neglected, yet important, tumor,” said Lance Leopold.

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