Clinical TrialAug 13, 2026, 06:08 AM
Cullinan Therapeutics' Zipalertinib Phase 3 Trial Meets Primary Endpoint
AI Summary
Cullinan Therapeutics, in collaboration with Taiho Oncology and Taiho Pharmaceutical, announced that its global Phase 3 REZILIENT3 clinical trial met its primary endpoint of progression-free survival (PFS) at a planned interim analysis. The trial evaluated zipalertinib combined with platinum-based chemotherapy for the first-line treatment of non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The zipalertinib arm showed statistically significant and clinically meaningful improvement in PFS with manageable safety, leading to a recommendation to unblind the study. The companies plan to seek U.S. regulatory approval for this combination regimen.
Key Highlights
- REZILIENT3 global Phase 3 clinical trial met its primary endpoint of progression-free survival (PFS).
- Trial evaluated zipalertinib plus chemotherapy vs. chemotherapy alone for NSCLC with EGFR ex20ins mutations.
- Demonstrated statistically significant and clinically meaningful improvement in PFS in the zipalertinib arm.
- Observed safety for the zipalertinib arm was manageable.
- Independent Data Monitoring Committee recommended unblinding the clinical trial.
- Cullinan Therapeutics and Taiho plan to pursue U.S. regulatory approval for the combination regimen.
- Full results from the REZILIENT3 trial will be submitted for presentation at an international medical conference.
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