Incyte’s PD-1 Drug Zynyz: A Strategic Pipeline Component Despite Recent Trial Success

Clinical Trial Success:
Incyte's PD-1 drug Zynyz has shown significant improvements in reducing tumor progression or death in patients with untreated, inoperable, locally recurrent or metastatic squamous cell anal carcinoma (SCAC) when combined with chemotherapy.

Strategic View:
Despite the trial win, Incyte CEO Hervé Hoppenot views Zynyz as a pipeline aide, indicating a broader strategic focus beyond just this drug.

Regulatory Path:
Incyte plans to discuss the findings with the FDA to decide the next steps for approval, aiming to file a supplemental Biologics License Application (sBLA) by the end of 2024.

Competitive Landscape:
The first-line NSCLC indication is highly competitive, with Merck’s Keytruda being the established standard of care, which may impact Zynyz's approval prospects.

Previous Rejection:
Zynyz was previously rejected by the FDA in 2021 for second-line anal cancer treatment due to concerns over unrelated deaths and low tumor response rates.

Diverse Trial Population:
The POD1UM-304 trial included a diverse population across the Americas, Europe, and Asia, which Incyte believes strengthens the study's validity.

Pipeline Evolution:
Incyte has retreated from further development of its oral PD-L1 inhibitors and other antibodies, focusing on commercially successful products like Jakafi and Opzelura.