Cullinan and Taiho Plan FDA Filing for Lung Cancer Pill Zipalertinib Despite Patient Deaths
Taiho Oncology and Cullinan Therapeutics are moving forward with plans to file for FDA approval of their oral drug candidate, zipalertinib, for non-small cell lung cancer (NSCLC), despite three patient deaths reported during a late-stage study. The Phase 3 REZILIENT3 trial demonstrated that zipalertinib, when combined with chemotherapy, significantly improved progression-free survival (PFS) in patients with first-line advanced non-squamous NSCLC harboring exon 20 mutations to the EGFR gene. Patients receiving the zipalertinib regimen experienced a 50% reduction in the risk of death or disease progression, with a median PFS of 14.5 months compared to 8.5 months in the control group. While adverse events of grade 3 or higher were more frequent in the zipalertinib arm (87% vs. 54.4%), analysts believe the robust efficacy and potential mitigation strategies will outweigh the safety concerns.
