Cullinan Therapeutics to Present Results from REZILIENT1, a Phase 1/2 Trial of Zipalertinib in Patients with Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Received Prior Therapy, at ASCO 2025
Cullinan and Taiho previously announced the Phase 2b portion of the study met the primary endpoint of overall response rate
CAMBRIDGE, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that results from the REZILIENT1 study of zipalertinib in non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (ex20ins) who have received prior therapy will be presented in an oral abstract session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 30–June 3, 2025. The data will include results from the Phase 2b portion of the study, which explored zipalertinib monotherapy in patients with advanced or metastatic EGFR ex20ins NSCLC who progressed after prior treatment with platinum-based chemotherapy with or without amivantamab and other ex20ins-targeted therapies.
“Despite an evolving treatment landscape, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations continue to have limited treatment options and poor disease outcomes,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “The results from REZILIENT1 show zipalertinib demonstrated clinically meaningful efficacy and a manageable safety profile in patients who have received prior platinum-based chemotherapy, including those who were treated with amivantamab, and zipalertinib has the potential to address significant unmet need in these patient settings. We look forward to sharing these important results with the lung cancer community through our oral presentation at the 2025 ASCO Annual Meeting.”
The details of the presentation include:
Presentation Title: Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab
Presenting Author: Helena A. Yu, MD, Memorial Sloan Kettering Cancer Center
Abstract Number: 8503
Session: Oral Abstract Session – Lung Cancer – Non-Small Cell Metastatic
Presentation Date and Time: Sunday, June 1, 2025, 8:00 AM-11:00 AM CDT
Live and Virtual Investor Event
Cullinan will host an in-person event for analysts and institutional investors on Sunday, June 1, 2025, at 6:30 PM CDT, during which Danny Nguyen, MD, Assistant Clinical Professor, City of Hope National Medical Center, will participate in a discussion of the zipalertinib data shared at the 2025 ASCO Annual Meeting with members of Cullinan management. Participants from Cullinan Therapeutics include Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, MD, MBA, Chief Medical Officer.
Investors and analysts are invited to register to attend in person by emailing Nick Smith, Head of Investor Relations (). A webcast will be available via the events page of the Company’s investor relations website at .
About Zipalertinib
Zipalertinib (CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was engineered 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 being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc.
About Cullinan Therapeutics
(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 , and follow us on and .
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 this unmet 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 INDs or other global 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:
Investors
Nick Smith
+1 401.241.3516
Media
Rose Weldon
+1 215.801.7644
