Core Insights - The REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, met its primary endpoint of overall response rate [1][2][3] - Zipalertinib is an orally available small molecule designed to target specific EGFR mutations, particularly exon 20 insertions, and has received Breakthrough Therapy Designation from the FDA [4][5] Company Overview - Taiho Pharmaceutical Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd., focusing on oncology and immune-related diseases, with a commitment to improving human health [6][7] - Taiho Oncology, Inc. specializes in developing and commercializing orally administered anti-cancer agents, with a robust pipeline targeting various tumor types [7] - Cullinan Therapeutics, Inc. is dedicated to creating new standards of care in cancer treatment, with a diversified portfolio of clinical-stage assets [9] Clinical Trial Details - The REZILIENT1 trial (NCT04036682) evaluates the efficacy and safety of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who have received prior therapy [3] - Preliminary results have been published in the Journal of Clinical Oncology, indicating promising outcomes for zipalertinib [3][12] Regulatory Plans - Full results from the REZILIENT1 trial will be presented at an upcoming international medical conference, with plans to submit for U.S. regulatory approval in the second half of 2025 [2]
Taiho Pharmaceutical, Taiho Oncology, and Cullinan Therapeutics Announce Primary Endpoint Met in Phase 2b Trial of Zipalertinib in Patients with Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Received Prior Therapy