Zipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung Cancer

On August 19, 2026 Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) reported that results from the planned interim analysis of the Phase 3 REZILIENT3 trial have been selected for presentation in the Presidential Symposium 2 at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC), to be held September 12-15, 2026, in Seoul, South Korea. REZILIENT3 evaluates zipalertinib plus chemotherapy versus chemotherapy alone in the first-line treatment of patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC).

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The Presidential Symposium 2 is a premier plenary session featuring notable advances in lung cancer research and treatment with the potential to change clinical practice.

Session information for the abstract is listed below. Full abstract details will be available via the conference website in accordance with IASLC embargo policies.

Title: Zipalertinib plus Chemotherapy for 1st-line NSCLC with EGFR Exon 20 Insertions: Results from the Phase 3 Trial (REZILIENT3)
Presenting Author: Dr. Daniel Tan Shao Weng, Duke Health, Singapore
Session Name: PL03 Presidential Symposium 2 Including Lectureship Award Presentations
Session Type: Presidential Symposium
Session Date: Monday, September 14, 2026
Session Time: 8 a.m. KST
Location: Plenary, Hall D2, 3F

About the REZILIENT3 Trial

This multicenter, randomized, controlled, open-label global trial enrolled 285 adults with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. The primary objective of this trial is to assess progression-free survival in the zipalertinib plus chemotherapy arm versus the chemotherapy arm.

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. 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 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 EGFR Exon 20 Insertion Mutations

NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,1 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Taiho, AUG 19, 2026, View Source [SID1234670236])