Taiho and Cullinan's Zipalertinib Meets Phase 3 Goal in First-Line Lung Cancer

Taiho Pharmaceutical and Cullinan Therapeutics' candidate zipalertinib significantly improved progression-free survival in a late-stage trial for patients with advanced non-small cell lung cancer, the partners announced August 12, with the REZILIENT3 study meeting its primary endpoint at an interim analysis.

A New First-Line Option

REZILIENT3, a global Phase 3 study of 285 adults with previously untreated, locally advanced or metastatic non-squamous NSCLC harboring EGFR exon 20 insertion mutations, evaluated zipalertinib plus platinum-based chemotherapy against chemotherapy alone. The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival with manageable safety, and the Independent Data Monitoring Committee recommended unblinding the study. Full results will be presented at an upcoming international medical conference.

Competition Heats Up

Zipalertinib is already under FDA review as a monotherapy in previously treated EGFR ex20 NSCLC, with a decision expected by February 27. If approved in the first-line setting, the zipalertinib-chemo combo would be the third therapy to market in the indication, joining Zegfrovy — which showed a 10.3-month median PFS — and Johnson & Johnson's bispecific antibody Rybrevant plus chemotherapy, which demonstrated an 11.4-month median PFS. Following the announcement, Cullinan's shares rose 6.3 percent in after-hours trading to $20.84, a new 52-week high.