Taiho Oncology and Cullinan Therapeutics said their Phase 3 trial of zipalertinib plus chemotherapy cleared a registrational goal in frontline EGFR exon 20 insertion–positive lung cancer. The partners reported statistically significant, clinically meaningful progression-free survival improvements and initiated unblinding after an early data checkpoint. The result positions zipalertinib to directly challenge existing EGFR exon 20 therapies, while the FDA is already reviewing the drug in the second-line setting. With competitors continuing to build evidence blocks in similar molecular niches, the trial outcome may quickly determine whether zipalertinib can claim a major place in first-line treatment algorithms.