On July 22, 2025 Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., reported the presentation of new data from zipalertinib REZILIENT1 and REZILIENT2 trials at the International Association of the Study of Lung Cancer’s (IASLC) 2025 World Conference on Lung Cancer (WCLC), to be held September 6-9, 2025, in Barcelona, Spain (Press release, Taiho, JUL 22, 2025, View Source [SID1234654476]).
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The abstracts accepted for mini oral presentations include updated efficacy and safety data from the Phase 2b REZILIENT1 trial, focusing on patients with EGFR ex20ins NSCLC previously treated with amivantamab, as well as the preliminary efficacy and safety results from the Phase 2 parallel cohort REZILIENT2 trial in patients with advanced or metastatic NSCLC harboring uncommon non-ex20ins EGFR mutations.
"Previously, zipalertinib has demonstrated clinical activity against ex20ins and preclinical activity against uncommon, non-ex20ins EGFR-mutant NSCLC," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We look forward to sharing updated data from the REZILIENT1 and REZILIENT2 trials at the upcoming 2025 World Conference on Lung Cancer, suggesting the potential for zipalertinib to make a meaningful difference in the lives of patients with certain types of NSCLC."
"Despite advances in the treatment landscape, there remains significant unmet need for NSCLC patients with EGFR exon 20 insertion mutations and for those with uncommon non-ex20ins EGFR mutations," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Taken together, the updated results from REZILIENT1 and new data from the REZILIENT2 study highlight the potential of zipalertinib to play an important role in the evolving treatment landscape for patients with NSCLC harboring less common EGFR mutations."
Session titles and information for the two abstracts are listed below. Full abstract details will be available via the conference website at 1 p.m. EDT August 13, 2025.
Title: Zipalertinib in NSCLC Patients (Pts) With EGFR Exon 20 Insertion (Ex20Ins) Mutations Who Received Prior Amivantamab
Session Name: MA08 – Common and Uncommon EGFR Mutations, New Treatments in the Horizon
Session Type: Mini Oral Presentation
Session Date: Tuesday, September 9, 2025
Session Time: 11:30 a.m. – 12:45 p.m. CEST
Presenter: Zofia Piotrowska, MD
Title: Phase 2 Interim Results of Zipalertinib in Patients With NSCLC Harboring Uncommon Non-Exon 20 Insertion EGFR Mutations
Session Name: MA08 – Common and Uncommon EGFR Mutations, New Treatments in the Horizon
Session Type: Mini Oral Presentation
Session Date: Tuesday, September 9, 2025
Session Time: 11:30 a.m. – 12:45 p.m. CEST
Presenter: Hibiki Udagawa, MD, PhD
About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.
Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.