Zipalertinib (CLN-081/TAS6417) - (REZILIENT3)

August 12, 2026: Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics (NASDAQ: CGEM) announced that the global Phase 3 REZILIENT3 trial met its primary endpoint at a planned interim analysis. In previously untreated adults with locally advanced or metastatic non-squamous NSCLC harboring EGFR exon 20 insertion mutations, zipalertinib plus platinum-based chemotherapy showed a statistically significant and clinically meaningful progression-free survival benefit versus chemotherapy alone.

The companies said safety in the zipalertinib arm was manageable, and the Independent Data Monitoring Committee recommended unblinding the study. REZILIENT3 enrolled 285 patients and will continue to monitor efficacy and safety.

Zipalertinib (CLN-081/TAS6417) remains investigational and has not been approved by any health authority. Based on the interim Phase 3 results, and pending discussions with the FDA, the companies plan to pursue U.S. regulatory approval of zipalertinib in combination with chemotherapy for first-line treatment of EGFR exon 20 insertion-mutant NSCLC. Full REZILIENT3 results are planned for submission to an upcoming international medical conference.