Incyte Corporation — Zynyz EMA EPAR public assessment report (EMEA/H/C/006194, 2024)

Report summary

The EMA granted marketing authorization for Zynyz (retifanlimab), an anti-PD-1 monoclonal antibody, for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The application, submitted in February 2023, received a positive opinion in February 2024, and Zynyz holds orphan medicinal product designation for MCC. Manufacturing, quality control, and stability of retifanlimab were deemed acceptable. Non-clinical studies confirmed its anti-PD-1 activity and assessed pharmacokinetics and toxicology in cynomolgus monkeys. Clinical pharmacokinetic studies in cancer patients, including MCC, showed dose proportionality and identified factors influencing clearance. Pharmacodynamic studies detailed its mechanism and receptor occupancy. The POD1UM-201 Phase 2 study in advanced MCC demonstrated an objective response rate of 53.5% and a median duration of response of 25.3 months, supporting its first-line use. Safety data, consistent with other PD-(L)1 inhibitors, revealed common adverse events like anemia and elevated AST, along with immune-related adverse events (irAEs) and infusion-related reactions (IRRs). The overall safety profile was evaluated across various patient populations, including those with hepatic impairment and HIV.

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