Taiho Oncology and Cullinan Therapeutics reported a second Phase 3 win for zipalertinib, clearing the registrational trial’s front-line efficacy goal for EGFR exon 20 insertion–positive lung cancer. The companies said the study met a pre-planned threshold for unblinding, setting up a direct challenge to Johnson & Johnson’s existing EGFR exon 20 franchise. In parallel, regulators are already reviewing zipalertinib in the second-line setting, with expectations for an FDA decision by late February. The Phase 3 success expands the competitive field for targeted EGFR exon 20 therapies as sponsors push into earlier lines with oral small molecules.