Incyte’s PD-(L)1 inhibitor headed for an ODAC showdown next month
The FDA’s Oncologic Drugs Advisory Committee will spend a half day on June 24 reviewing Incyte’s PD-(L)1 inhibitor retifanlimab as a treatment for locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) for those who have progressed on or who are intolerant of platinum-based chemotherapy.
The eighth PD-(L)1 entrant in January nabbed a priority review and an orphan designation from the FDA, which sets the agency’s final decision date as July 25.
“Patients with SCAC who have progressed after first-line chemotherapy treatment currently have no approved treatments available,” Lance Leopold, VP of immuno-oncology clinical development said in a statement.
Incyte’s BLA is centered on a Phase II trial involving 94 patients that demonstrated an overall response rate of 14%, median duration of response of 9.5 months, progression-free survival of 2.3 months and overall survival of 10.1 months. During its last showcase at the European Society for Medical Oncology meeting, the biotech emphasized that the drug appears active in HIV-positive patients and regardless of PD-L1 expression or the presence of liver metastasis.
“We are confident in the benefit-risk profile of retifanlimab and look forward to the discussion with these medical experts and patients as we continue to work with the FDA to bring this novel immunotherapy to patients with SCAC who are in need of additional treatment options,” a company spokesperson said.
But biotech analysts don’t think this will be a blockbuster indication.
Investment bank SVBLeerink is projecting about $100 million peak sales in 2030. Truist’s Srikripa Devarakonda expects peak worldwide sales of $43 million in this indication, although new indications such as lung cancer and Merkel cell carcinoma may push it to around $500 million.
Incyte and Macrogenics are also testing retifanlimab in combination with the potential anti-Her2 drug margetuximab as a first-line gastric cancer treatment. Retifanlimab-combination studies sponsored by Incyte also include regimens with parsaclisib (PI3Kd inhibitor), pemigatinib (FGFR 1/2/3 inhibitor), epacadostat (IDO1 inhibitor), INCB106385 (A2A/A2B inhibitor), INCB081776 (AXL/MER inhibitor), and various chemotherapy regimens, according to Mizuho analyst Mara Goldstein.
In 2019, Incyte and Zai Lab also unveiled a licensing agreement for the development and commercialization of retifanlimab in China.