Retifanlimab

Phase 3 POD1UM-304 trial of retifanlimab met primary endpoint of overall survival (OS) and all secondary endpoints in previously untreated metastatic non-small cell lung cancer (NSCLC). Median OS was 18.1 months in the retifanlimab and chemotherapy group vs. 13.4 months in the placebo group. Data support planned 2025 filing of a supplemental Biologics License Application (sBLA) in the U.S.

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Incyte's Phase 3 POD1UM-304 trial of retifanlimab (Zynyz®) in combination with platinum-based chemotherapy for previously untreated metastatic non-small cell lung cancer (NSCLC) met its primary endpoint with significant improvement in overall survival (18.1 months vs 13.4 months for chemotherapy alone). Secondary endpoints also showed improvements in progression-free survival, overall response rate, and duration of response. The treatment was generally well-tolerated, with common side effects including anemia, decreased appetite, and decreased neutrophil count. Incyte plans to submit a supplemental Biologics License Application in 2025.

Incyte presents 20 oncology data presentations at 2024 ASH Annual Meeting, including Phase 3 inMIND study results on tafasitamab in follicular lymphoma. Hosts virtual analyst and investor event on December 12, 2024.

Zynyz (retifanlimab) plus chemotherapy significantly improved progression-free survival in advanced anal cancer patients, according to a Phase III trial presented at ESMO 2024, suggesting it may become a new standard of care. The trial included people with HIV and showed a 37% reduction in disease progression risk, with Zynyz recipients experiencing longer progression-free survival and response duration compared to placebo recipients. Incyte plans to seek FDA approval for Zynyz in anal cancer by year-end.

Incyte's PD-1 inhibitor Zynyz, after initial FDA rejection for SCAC, shows potential in first-line setting with chemo, improving PFS and OS in POD1UM-303 study. Incyte's CDK2 inhibitor INCB123667 shows promise in ovarian cancer, with plans for phase 3 trials starting in 2025.

AstraZeneca's Imfinzi in bladder cancer reduced death risk by 25%; Merck and Eisai's combo in liver cancer cut progression or death risk by a third; Bristol's lung cancer approach faced criticism for 'cherry-picking' subgroups.

Retifanlimab plus carboplatin and paclitaxel improved progression-free survival for recurrent or metastatic SCAC, according to the phase 3 POD1UM-303/InterAACT 2 study.