Amivantamab-VMJM

What we commonly refer to as lung cancer is in fact many different types of diseases. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases. But it wasnt until recently that we understood the breadth of molecular subsets that comprise NSCLC, each with unique implications for prognosis and management. Identification of the epidermal growth factor receptor (EGFR) in 2004 marked a pivotal moment in the era of precision medicine for lung cancer.Breakthroughs like theselarge leaps in scientific understanding that deliver profound advances for patient outcomesinspire our spirit of innovation at Cullinan. In our pursuit of medicines that improve patient lives, we seek to build on these important scientific insights, knowing that despite the progress made, many patients have not been able to benefit from these advances.A persistent challenge in lung cancerAmong the lung cancer population with EGFR mutations, patients with insertions at exon 20 (ex20ins) represent a significant unmet need segment. These patients often have poorer outcomes compared to those with more common EGFR mutations, such as exon 19 deletions. Ex20ins mutations can be challenging to detect with traditional biomarker testing and frequently convey resistance to approved tyrosine kinase inhibitors (TKIs), unlike mutations in exons 18, 19, and 21, which increase sensitivity to those drugs. After 20 years of advances, treatment options remain limited for those with EGFR ex20ins advanced or metastatic disease, especially for patients who have exhausted available treatment options.Where do we go from here? The industry must adopt innovative strategies that push the boundaries of scientific progress, accelerate the availability of new treatments, and work across disciplines to deliver medicines that improve the lives of as many patients as possible.As our clinical development strategy at Cullinan Therapeutics advances to later stages, a few key principles guide our approach: creativity paired with discipline, and putting people first.These principles give us the best chance at delivering what we hope will be truly meaningful medicines.Disciplined science rooted in expertiseThe significant unmet need in people with EGFR ex20ins NSCLC gives us a roadmap for what it would take for a medicine to be clinically meaningful. Our urgency to offer patients more options led Cullinan to collaborate with researchers at Taiho Oncology to more fully explore the potential of a novel investigational treatment for EGFR ex20ins mutations in NSCLC. Complementary expertise enabled our companies to explore creative ways of designing clinical trials. Together, we developed a comprehensive clinical development plan in a variety of treatment settings in EGFR ex20ins NSCLC. We recently reportedpositive outcomes from our investigational treatment for patients with ex20ins NSCLC whose disease had progressed despite already receiving prior standard of care treatments such as chemotherapy, amivantamab, and other ex20ins-directed therapies.This success highlights the potential of our investigational treatment, but what is most meaningful is that an oral therapy that delivers efficacy with a manageable safety profile could represent a significant advance for these patients with heavily pre-treated EGFR ex20ins NSCLC. Buoyed by this progress, we are working swiftly with the goal of making this option broadly availablea testament to our commitment to our mission of bringing new standards of care to more patients.Hands-on approach driving outcomesClinical trial success hinges upon support and simplicityprograms must be scientifically robust yet also practical to implement. A disciplined approach extending across collaborations with others in the clinical development ecosystem helps us leverage external resources while maintaining a lean, efficient internal team. Success also depends on how we put people first. At Cullinan, we have built a team with expertise in the design and execution of clinical studies who share a commitment to strong collaboration with investigators. We prioritize our accessibility to these critical external collaborators, listening to and adapting to their needs. As a clinician, I know that physicians serve as both interpreters and connectors of patients who are experts in their own disease. These invaluable insights are crucial for both the execution of studies and the development of transformational medicines that address patient needs. Looking aheadProgress made to date in lung cancer, and hopefully soon for patients living with EGFR exon20ins NSCLC, would not have been possible without the tireless work of the many scientists, investigators, advocates, and patients collectively pursuing a better future. As an industry, we have the tools to solve the worlds greatest scientific challenges. Our mandate is to remain disciplined and focused, agile, and inventive, so that we may realize these solutions for patients. '

PRINCETON, N.J. and CAMBRIDGE, Mass., June 1, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO). REZILIENT1 is a Phase 1/2, global, multicenter study of zipalertinib (development code: CLN-081/TAS6417) in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who have received prior therapy. Results from the REZILIENT1 trial will be presented in a simultaneous oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8503). Continue Reading Cullinan Therapeutics The full publication, titled Zipalertinib in Patients With Epidermal Growth Factor Receptor Exon 20 Insertion-Positive Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab, can be found here. Highlights of the REZILIENT1 Phase 1/2 trial in the authors' conclusions include: Zipalertinib demonstrated clinically meaningful efficacy in the primary efficacy population (n=176), including 51 patients who had received prior amivantamab. The confirmed objective response rate (ORR) was 35.2% overall, and median duration of response (mDOR) and progression-free survival were 8.8 months and 9.4 months, respectively. In patients treated after prior platinum-based chemotherapy only (n=125), ORR was 40% with mDOR of 8.8 months. The safety profile of zipalertinib was manageable and consistent with previously reported data.¹ In exploratory subgroup analyses: Patients who had received prior amivantamab without other ex20ins-targeted therapy showed a confirmed ORR of 30% and mDOR of 14.7 months. Patients with brain metastases showed a confirmed ORR of 30.9% and a mDOR of 8.3 months. "Despite recent treatment advances for patients with EGFR ex20ins-mutant NSCLC, there is a lack of oral targeted therapies for patients whose tumors harbor these mutations," said principal investigator Zofia Piotrowska, MD, Assistant Professor, Medicine, Harvard Medical School and a clinical researcher and lung cancer medical oncologist at the Massachusetts General Hospital Cancer Center. "Findings from the Phase 1/2 REZILIENT1 trial support our understanding of zipalertinib as a potential targeted therapy option for patients living with previously treated recurrent or metastatic NSCLC harboring EGFR ex20ins mutations." Taiho Oncology is actively recruiting patients in the Phase 3 REZILIENT3 trial (NCT05973773). About REZILIENT1 REZILIENT1 (Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in adult patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. The primary endpoints were ORR and DOR as assessed by blinded independent central review (ICR) per RECIST v1.1. Adverse events were characterized and graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0). 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 EGFR Exon 20 Insertion Mutations NSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,3 with insertions at exon 20 accounting for up to 12% of these mutations.2 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 , and follow us on LinkedIn and X. 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 , 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. References 1. Piotrowska Z, Tan DS, Smit EF, et al. Safety, tolerability, and antitumor activity of zipalertinib among patients with non-small-cell lung cancer harboring epidermal growth factor receptor exon 20 insertions. Journal of Clinical Oncology. Available at: . 2. Burnett H, Emich H, Carroll C, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. PLOS ONE. 2021;16(3):e0247620. Available at: . 3. Riess JW, Gandara DR, Frampton GM, et al. Diverse EGFR exon 20 insertions and co-occurring molecular alterations identified by comprehensive genomic profiling of NSCLC. Journal of Thoracic Oncology. 2018 Jul 5;13(10):1560–1568 . Available at: (18)30770-6/pdf. Contacts Taiho Oncology Leigh Labrie + 609.664.9878 [email protected] Cullinan Therapeutics Investors Nick Smith +1 401.241.3516 [email protected] Media Jessica Weinstein +1 508.254.3881 [email protected] SOURCE Taiho Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED