Cullinan and Taiho Report Phase III Win for Zipalertinib–Chemotherapy Combo in First-Line EGFR Exon 20 Insertion

Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics have announced that the Phase III REZILIENT3 trial of zipalertinib combined with platinum-based chemotherapy met its primary endpoint of progression-free survival (PFS) as a first-line treatment for patients with locally advanced or metastatic EGFR exon 20 insertion-mutated non-small cell lung cancer (NSCLC). The trial, which enrolled 285 adults, showed a statistically significant and clinically meaningful improvement in PFS for the zipalertinib plus chemotherapy arm compared with chemotherapy alone, with a manageable safety profile. The Independent Data Monitoring Committee recommended unblinding the study, and full results are expected to be presented at an upcoming international medical conference. Zipalertinib, an oral irreversible EGFR tyrosine kinase inhibitor, is being developed by Taiho Oncology in collaboration with Cullinan Therapeutics in the U.S., and is already under review by the FDA for patients previously treated with platinum-based chemotherapy.