Taiho Oncology and Cullinan Therapeutics Announce Acceptance of Abstracts for Zipalertinib at the IASLC 2025 World Conference on Lung Cancer

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Cullinan Therapeutics (NASDAQ:CGEM) and Taiho Oncology announced the acceptance of two abstracts for presentation at the IASLC 2025 World Conference on Lung Cancer in Barcelona, featuring new data for zipalertinib in non-small cell lung cancer (NSCLC).

The presentations will include updated efficacy data from the Phase 2b REZILIENT1 trial studying zipalertinib in patients with EGFR exon 20 insertion mutations who previously received amivantamab treatment. Additionally, preliminary findings from the Phase 2 REZILIENT2 trial will be presented, focusing on patients with uncommon non-ex20ins EGFR mutations.

Both abstracts will be presented on September 9, 2025, during the mini oral session "Common and Uncommon EGFR Mutations, New Treatments in the Horizon." Full abstract details will be available on August 13, 2025.

Insights

Oncology Clinical Development Expert

Cullinan's zipalertinib abstract acceptance signals positive progression in EGFR mutation-driven NSCLC clinical development, boosting its therapeutic potential.

The acceptance of two abstracts for zipalertinib at the prestigious WCLC represents a significant milestone in Cullinan Therapeutics' clinical development program. The upcoming presentations will showcase updated efficacy data from REZILIENT1 in patients previously treated with amivantamab, plus preliminary findings from REZILIENT2 examining uncommon non-ex20ins EGFR mutations.

These presentations are particularly noteworthy as they address two distinct underserved patient populations with limited treatment options. For EGFR ex20ins mutations, which comprise approximately 4-12% of all EGFR mutations in NSCLC, current therapies have limitations in efficacy and tolerability. The second cohort focusing on uncommon non-ex20ins EGFR mutations represents another area of high unmet need.

The timing of these presentations in September 2025 suggests the clinical development program is progressing as planned. The commentary from both companies' Chief Medical Officers emphasizing "clinical activity" and "potential to make a meaningful difference" hints at potentially positive results, though specific efficacy metrics aren't disclosed in this announcement.

For Cullinan's pipeline, zipalertinib represents an important asset targeting precision oncology indications. If the data demonstrates compelling efficacy in these difficult-to-treat subpopulations, particularly in the post-amivantamab setting where resistance often develops, it could position zipalertinib as an important addition to the treatment landscape for these molecularly-defined lung cancers.

• Updated efficacy data will be presented from the REZILIENT1 trial of zipalertinib in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who were previously treated with amivantamab
• Preliminary findings to be shared from the cohort of patients with uncommon non-ex20ins EGFR mutations enrolled in the REZILIENT2 trial of zipalertinib

PRINCETON, N.J. and CAMBRIDGE, Mass., July 22, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced 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.

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.

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.

About Cullinan Therapeutics
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan's portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow us on LinkedIn and X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company's beliefs and expectations regarding our plans regarding future data presentations, the clinical development and regulatory filing plan and timeline of zipalertinib, the safety and efficacy profile of zipalertinib and its potential to address unmet medical need, and other statements that are not historical facts. The words "believe," "continue," "could," "estimate," "expect," "intends," "may," "plan," "potential," "project," "pursue," "will," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any NDA or other regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

Contacts

Taiho Oncology
Leigh Labrie
+1 609.664.9878  
LLabrie@taihooncology.com

Cullinan Therapeutics
Investors
Nick Smith
+1 401.241.3516
nsmith@cullinantx.com

Media 
Rose Weldon   
+1 215.801.7644   
rweldon@cullinantx.com

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SOURCE Taiho Oncology

FAQ

What data will Cullinan Therapeutics (CGEM) present at WCLC 2025 for zipalertinib?

Cullinan will present updated efficacy data from the Phase 2b REZILIENT1 trial in NSCLC patients with EGFR ex20ins mutations, and preliminary results from the Phase 2 REZILIENT2 trial in patients with uncommon non-ex20ins EGFR mutations.

When and where will the zipalertinib data be presented at WCLC 2025?

The data will be presented on September 9, 2025, from 11:30 a.m. to 12:45 p.m. CEST at the World Conference on Lung Cancer in Barcelona, Spain.

Who are the presenting researchers for the zipalertinib studies at WCLC 2025?

Dr. Zofia Piotrowska will present the REZILIENT1 trial data, and Dr. Hibiki Udagawa will present the REZILIENT2 trial results.

What type of cancer patients are being studied in the zipalertinib trials?

The trials focus on patients with non-small cell lung cancer (NSCLC) who have either EGFR exon 20 insertion mutations or uncommon non-ex20ins EGFR mutations.

When will the full abstract details for zipalertinib be available?

The full abstract details will be available on the conference website at 1 p.m. EDT on August 13, 2025.