Taiho Oncology and Cullinan Therapeutics Present Data on Zipalertinib at the IASLC 2025 World Conference on Lung Cancer
Taiho Oncology and Cullinan Therapeutics Present Data on Zipalertinib at the IASLC 2025 World Conference on Lung Cancer |
| [09-September-2025] |
PRINCETON, N.J. and CAMBRIDGE, Mass., Sept. 9, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced new data from the REZILIENT1 and REZILIENT2 trials of zipalertinib, an oral EGFR tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC). These data will be presented at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer as mini oral presentations on September 9 during the "MA08 - Common and Uncommon EGFR Mutations, New Treatments in the Horizon" session, from 11:30 a.m. – 12:45 p.m. CEST.
A mini oral presentation will highlight updated data from the pivotal Phase 2b REZILIENT1 trial of zipalertinib, focused on patients with NSCLC harboring EGFR ex20ins mutations, who have been previously treated with amivantamab.1 A second mini oral presentation will highlight Phase 2b preliminary efficacy and safety results from the ongoing, uncommon non-ex20ins EGFR mutations cohort of the REZILIENT2 trial of zipalertinib in patients with advanced or metastatic NSCLC harboring ex20ins and uncommon non-ex20ins EGFR mutations.2 "We're pleased to share longer-term follow-up data from the REZILIENT1 study of zipalertinib for patients with NSCLC harboring EGFR ex20ins mutations who have been previously treated with amivantamab," said Zofia Piotrowska, MD, Associate Professor of Medicine, Harvard Medical School and lung cancer clinical oncologist at the Mass General Cancer Center. "Despite recent treatment advancements, a significant medical need exists for this patient population, underscoring the importance of these data." "Uncommon non-exon 20 insertion EGFR mutations represent a significant clinical challenge, as they exhibit variable and often suboptimal responses to currently approved tyrosine kinase inhibitors," said Hibiki Udagawa, MD, PhD, thoracic medical oncologist, National Cancer Hospital East, Japan. "We are pleased to present the interim data from the uncommon non-ex20ins EGFR mutations cohort from the REZILIENT2 trial, potentially demonstrating the need for novel, targeted therapeutic approaches for this patient population." Authors reported results from the REZILIENT1 study of zipalertinib from the cohort of NSCLC patients with EGFR ex20ins mutations who received prior amivantamab therapy1 Summary of Efficacy - by Blinded Independent Central Review (BICR): With follow-up of more than 9 months, zipalertinib demonstrated:
Summary of Safety and Tolerability The most common treatment-emergent adverse events (TEAEs, all-grade) were paronychia (41.7%), anemia (38.1%), rash (34.5%), nausea (28.6%), diarrhea (22.6%), dry skin (21.4%), dermatitis acneiform (21.4%) and dyspnea (20.2%). The most common grade ≥3 TEAEs were anemia (15.5%), pneumonia (10.7%), dyspnea (6.0%), rash (3.6%), diarrhea (2.4%) and stomatitis (2.4%). Authors reported results from the REZILIENT2 study of zipalertinib from the cohort of patients with NSCLC harboring uncommon non-exon 20 insertion EGFR mutations2 Summary of Preliminary Efficacy –by Investigator As of the data cut-off, zipalertinib demonstrated:
Summary of Preliminary Safety and Tolerability The most common treatment-related adverse events (TRAEs, all-grade) were paronychia (47.5%), dermatitis acneiform (37.5%), stomatitis (32.5%), anemia (30.0%), diarrhea (22.5%), rash (20.0%), and dry skin (15.0%). The majority of TRAEs were grade 1 or 2. The most common grade ≥3 TRAEs were paronychia (5.0%), pneumonitis and anemia (5.0%). About REZILIENT1 About REZILIENT2 About Zipalertinib 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. 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 Taiho Pharmaceutical Co., Ltd. About Cullinan Therapeutics Forward Looking Statements 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 Cullinan Therapeutics Investors Media References: 1. Z. Piotrowska et al. Zipalertinib in NSCLC patients (pts) with EGFR exon 20 insertion (ex20ins) mutations who received prior amivantamab 2. Hibiki Udagawa et al. Phase 2 Interim Results of Zipalertinib in Patients With NSCLC Harboring Uncommon Non-Exon 20 Insertion EGFR Mutations
SOURCE Taiho Oncology | ||
Company Codes: NASDAQ-NMS:CGEM |
View original content to download multimedia:
