Taiho Oncology Announces Acceptance of Abstract for Zipalertinib at the ESMO Congress 2025

• Preliminary findings to be shared from Cohort C (active brain metastases) of the REZILIENT2 trial of zipalertinib in patients with exon 20 insertion (ex20ins) or other uncommon mutation epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC)

PRINCETON, N.J., July 25, 2025 /PRNewswire/ -- Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, announced it will present new data from the REZILIENT2 trial of zipalertinib at the European Society for Medical Oncology (ESMO) Congress 2025, to be held Oct. 17-21, 2025, in Berlin, Germany.

The abstract accepted for a mini oral presentation includes the preliminary efficacy and safety data from the Phase 2b REZILIENT2 trial of zipalertinib, an oral, highly selective, irreversible EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic NSCLC harboring EGFR ex20ins mutations or EGFR uncommon non-ex20ins mutations and active brain metastases and/or leptomeningeal disease.

"We look forward to presenting the latest findings from Cohort C of our REZILIENT2 trial, which focuses on a subset of patients with ex20ins NSCLC with central nervous system involvement, at this year's ESMO Congress," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We are excited to share more details from our zipalertinib program, building upon its potential to make a meaningful impact in a disease area of unmet need."

The session title and information for the accepted abstract are listed below. Full abstract details will be available via the conference website at 12:05 CEST a.m. on Oct. 13, 2025.

Title:Activity of Zipalertinib Against Active Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR Exon 20 Insertion (Ex20ins)/Other Uncommon Mutations
Abstract Number: 3778
Session Name: Mini oral session 1: NSCLC metastatic
Session Type: Mini Oral Presentation
Session Date:Oct. 19, 2025
Session Time:8:30 to 10 a.m. CEST

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.

About Taiho Oncology, Inc.
The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada.

For more information, visit https://www.taihooncology.com/, and follow us on LinkedIn and X.

Taiho Oncology and the Taiho Oncology logo are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries.

Taiho Oncology Contact:
Leigh Labrie
(609) 664-9878
LLabrie@taihooncology.com

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SOURCE Taiho Oncology