Taiho and Cullinan report positive Phase 3 results for zipalertinib in EGFR exon 20 insertion lung cancer

Taiho Oncology and Cullinan Therapeutics announced that their experimental drug zipalertinib achieved positive results in a Phase 3 trial for first‑line treatment of lung cancer patients whose tumors carry EGFR exon 20 insertion mutations.

The trial, which combined zipalertinib with chemotherapy, was stopped early at an interim analysis because the combination showed a statistically significant and clinically meaningful improvement in progression‑free survival, meeting the pre‑specified criteria for unblinding.

The U.S. FDA is currently reviewing zipalertinib as a second‑line therapy, with a decision expected by Feb. 27. If approved, the drug would join a competitive market that already includes Johnson & Johnson’s Rybrevant, AstraZeneca/Dizal’s Zegfrovy, and upcoming data from ArriVent BioPharma.