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Taiho Oncology to Present Zipalertinib at ESMO Congress 2025

Taiho Oncology, a leading developer and commercializer of innovative cancer therapies, has announced its participation in the upcoming European Society for Medical Oncology (ESMO) Congress 2025. The event is scheduled from October 17 to 21, 2025, in Berlin, Germany, where the company will discuss new findings from its ongoing clinical studies.

The featured study revolves around zipalertinib, an oral and irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This important drug is designed specifically for patients suffering from advanced non-small cell lung cancer (NSCLC) with active brain metastases who possess exon 20 insertion mutations or other rare EGFR alterations. These patient demographics represent a significant challenge in oncology due to the complex nature of their conditions.

Dr. Harold Keer, MD, PhD, the Chief Medical Officer of Taiho Oncology, expressed anticipation for the presentation. The focus will be on Cohort C of the REZILIENT2 trial, which targets NSCLC patients exhibiting CNS involvement, highlighting the unmet medical needs within this subset. He stated, "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."

Key Details of the ESMO Presentation

The selected abstract for a mini oral presentation provides preliminary efficacy and safety results from the Phase 2b REZILIENT2 trial. This initiative explores the use of zipalertinib for patients whose condition has advanced or metastasized. Critical information related to the study includes:

• - Abstract Title: Activity of Zipalertinib Against Active Central Nervous System (CNS) Metastases in Patients With 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: October 19, 2025
• - Session Time: 8:30 to 10 a.m. CEST.

About Zipalertinib

Under development as a next-generation therapeutic, zipalertinib shows promise due to its selective targeting of EGFR mutations, particularly focusing on variants associated with exon 20 insertions. It has garnered Breakthrough Therapy Designation from the United States Food and Drug Administration (FDA), emphasizing its potential as a significant advancement in cancer treatments. However, it is crucial to note that zipalertinib remains investigational and has not yet received full approval from regulatory authorities.

Company Overview

Taiho Oncology, Inc. operates with a mission to enhance the quality of life for cancer patients and their families. The company’s portfolio comprises numerous orally administered anti-cancer agents tailored for various tumor types. Backed by a robust pipeline that includes small-molecule candidates targeting both solid tumors and hematologic malignancies, Taiho continues to spearhead efforts in advancing cancer treatment options. The company is a subsidiary of Taiwan’s Taiho Pharmaceutical Co., Ltd., with its main office in Princeton, New Jersey, overseeing Canadian and European operations.

For further updates, you can visit their official website Taiho Oncology or follow them on LinkedIn and X.

In anticipation of their presentation at ESMO 2025, Taiho Oncology is committed to exploring innovative therapeutic avenues that resonate with the pressing needs of patients facing challenging diagnoses.