Taiho Oncology and Cullinan Therapeutics said zipalertinib has cleared a registrational Phase 3 endpoint in frontline EGFR exon 20 insertion lung cancer, using an early data check to halt enrollment once results were clearly positive. The oral EGFR inhibitor was tested in combination with chemotherapy versus chemotherapy plus placebo, with the companies saying the regimen met a pre-planned threshold for unblinding. The FDA is already reviewing zipalertinib for a second-line setting, with a decision expected by Feb. 27, and Taiho and Cullinan positioned the Phase 3 readout as a path to challenge the established exon 20 market that includes J&J’s Rybrevant and AstraZeneca’s Dizal’s Zegfrovy. The competitive stakes are high because exon 20 insertions represent a small but commercially attractive subset of EGFR-mutant disease. While detailed efficacy numbers were not provided in the report, the companies said the combination achieved a statistically significant and clinically meaningful progression-free survival improvement. Investigators previously tested zipalertinib in a Phase 2 setting showing tumor shrinkage or elimination in more than one-third of patients, supporting the continued registrational push. With ArriVent BioPharma also expecting Phase 3 data later this year, the zipalertinib update intensifies the timeline pressure on FDA review and increases the likelihood of rapid label expansion across line-of-therapy strategies in EGFR exon 20-positive NSCLC.