Taiho Oncology’s Zipalertinib plus chemo extends PFS by 6 months in NSCLC trial

Taiho Oncology’s investigational drug zipalertinib, when combined with chemotherapy, demonstrated a statistically significant improvement in progression-free survival for patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, according to interim results from the Phase 3 REZILIENT3 trial. In the study, which enrolled 279 patients, those receiving zipalertinib at 100 mg twice daily alongside standard chemotherapy achieved a median progression-free survival (PFS) of 14.5 months, compared with 8.5 months for patients receiving chemotherapy alone. This represents a 6.0-month improvement in median PFS and a hazard ratio of 0.50, indicating nearly half the risk of progression or death in the combination arm. The primary endpoint was met at an interim analysis, with an objective response rate of 65.0% versus 40.3% for the combination versus chemotherapy alone, respectively. While overall survival data remain ongoing, the interim analysis showed a hazard ratio of 0.72 for death in favor of the combination therapy, though the confidence interval crossed 1.0, suggesting it was not statistically significant at this stage. Grade 3 or higher adverse events occurred in 87.1% of patients on the combination regimen, primarily manageable hematologic events, though EGFR-related toxicities were infrequent. The trial was presented at the World Conference on Lung Cancer in Seoul, South Korea, and the data were published on September 13, 2026.