Taiho and Cullinan’s zipalertinib shows progression‑free survival benefit in Phase 3 NSCLC trial

Taiho Pharmaceutical and Cullinan Therapeutics reported that their EGFR inhibitor zipalertinib, combined with chemotherapy, significantly extended progression‑free survival for patients with advanced non‑small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations in the Phase 3 REZILIENT3 trial.

The interim analysis met the study’s primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy alone. While the companies did not disclose the exact hazard ratio or median PFS values, they emphasized that the hazard ratio was below one, indicating a benefit.

Zipalertinib is already under FDA review for previously treated NSCLC, with a decision expected by February. The new data position the drug for a potential first‑line indication, pending further regulatory filing.