Press release
Incyte Announces Positive Results from Phase 3 Trial Evaluating Retifanlimab (Zynyz®) in Combination with Platinum-Based Chemotherapy in Patients with Non-Small Cell Lung Cancer
— Phase 3 POD1UM-304 trial met primary endpoint of overall survival (OS) and all secondary endpoints in patients with previously untreated metastatic
About this update from Incyte Corporation
[{"type":"text","content":"\n— Phase 3 POD1UM-304 trial met primary endpoint of overall survival (OS) and all secondary endpoints in patients with previously untreated metastatic non-small cell lung cancer (NSCLC)\n\n\n— Data presented at the European Society for Medical Oncology (ESMO) Asia Congress 2024 support the planned 2025 filing of a supplemental Biologics License Application (sBLA) in the U.S. for retifanlimab in NSCLC\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced results from the Phase 3 POD1UM-304 trial of retifanlimab (Zynyz®), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with platinum-based chemotherapy for the treatment of adults with previously untreated non-squamous and squamous metastatic non-small cell lung cancer (NSCLC) not harboring a driver mutation. These data were featured today in a mini oral presentation at the European Society for Medical Oncology (ESMO) Asia Congress 2024, held in Singapore and virtually.\n\n\nThe POD1UM-304 trial results show a clinically meaningful and statistically significant improvement over chemotherapy alone. Patients in the retifanlimab and chemotherapy combination treatment group achieved a median overall survival (OS) of 18.1 months compared to 13.4 months in the placebo and chemotherapy combination group (Hazard Ratio [HR]: 0.75; 95% Confidence Interval [CI] (0.60, 0.93); P=0.0042).\n\n\n“The positive POD1UM-304 trial results provide additional proof of retifanlimab’s safety and efficacy profile in solid tumors,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “We look forward to leveraging these results to advance our pipeline, particularly in hard-to-treat cancers like NSCLC, and to submitting a supplemental Biologic License Application for this indication to the U.S. Food and Drug Administration next year.”\n\n\nThe trial also met secondary endpoints, including:\n\n\n\nPatients who received retifanlimab in combination with chemotherapy had a 2-month improvement in median progression-free survival (PFS) compared to the placebo and chemotherapy combination group (7.7 vs 5.5 months; [HR: 0.64; 95% CI (0.52, 0.79); P10% of patients in the retifanlimab and chemotherapy combination treatment group, were anemia (62.7%), decreased appetite (22.6%) and decreased neutrophil count (22.1%). C...