Taiho Pharmaceutical, Taiho Oncology, and Cullinan Therapeutics Announce Primary Endpoint Met in Phase 2b Trial of Zipalertinib in Patients with Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Received Prior Therapy
Taiho Pharmaceutical, Taiho Oncology, and Cullinan Therapeutics announced successful results from their REZILIENT1 trial, a Phase 1/2 clinical study of zipalertinib (CLN-081/TAS6417). The trial met its primary endpoint of overall response rate in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations who received prior therapy.
The safety profile aligned with previous data presentations. The companies plan to present complete results at an upcoming international medical conference and intend to submit for FDA regulatory approval in the second half of 2025, pending discussions with the agency.
Taiho Pharmaceutical, Taiho Oncology e Cullinan Therapeutics hanno annunciato risultati positivi dal loro trial REZILIENT1, uno studio clinico di fase 1/2 su zipalertinib (CLN-081/TAS6417). Il trial ha raggiunto il suo obiettivo primario di tasso di risposta globale nei pazienti con cancro del polmone non a piccole cellule (NSCLC) con mutazioni di inserzione dell'esone 20 dell'EGFR che hanno ricevuto precedenti terapie.
Il profilo di sicurezza è risultato in linea con le presentazioni di dati precedenti. Le aziende prevedono di presentare i risultati completi in un imminente conferenza medica internazionale e intendono presentare domanda di approvazione normativa alla FDA nella seconda metà del 2025, in attesa di discussioni con l'agenzia.
Taiho Pharmaceutical, Taiho Oncology y Cullinan Therapeutics anunciaron resultados exitosos de su ensayo REZILIENT1, un estudio clínico de fase 1/2 sobre zipalertinib (CLN-081/TAS6417). El ensayo cumplió con su objetivo principal de tasa de respuesta general en pacientes con cáncer de pulmón no microcítico (NSCLC) con mutaciones de inserción en el exón 20 de EGFR que recibieron terapia previa.
El perfil de seguridad se alineó con presentaciones anteriores de datos. Las compañías planean presentar resultados completos en una próxima conferencia médica internacional e intentan solicitar la aprobación regulatoria de la FDA en la segunda mitad de 2025, a la espera de discusiones con la agencia.
타이호 제약, 타이호 온콜로지, 컬리난 테라퓨틱스는 zipalertinib (CLN-081/TAS6417)의 1/2상 임상시험인 REZILIENT1 시험에서 성공적인 결과를 발표했습니다. 이 시험은 이전 치료를 받은 비소세포 폐암 (NSCLC) 환자에서 EGFR 엑손 20 삽입 돌연변이와 관련된 전체 반응률이라는 주요 목표를 달성했습니다.
안전성 프로필은 이전 데이터 발표와 일치했습니다. 회사들은 다가오는 국제 의학 컨퍼런스에서 전체 결과를 발표할 계획이며, 해당 기관과의 논의 후 2025년 하반기에 FDA에 규제 승인 신청을 할 의도를 가지고 있습니다.
Taiho Pharmaceutical, Taiho Oncology et Cullinan Therapeutics ont annoncé des résultats positifs de leur essai REZILIENT1, une étude clinique de phase 1/2 sur zipalertinib (CLN-081/TAS6417). L'essai a atteint son objectif principal de taux de réponse global chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) avec des mutations d'insertion de l'exon 20 de l'EGFR ayant reçu un traitement préalable.
Le profil de sécurité était en accord avec les présentations de données antérieures. Les entreprises prévoient de présenter les résultats complets lors d'une prochaine conférence médicale internationale et envisagent de demander une approbation réglementaire de la FDA dans la seconde moitié de 2025, en attendant des discussions avec l'agence.
Taiho Pharmaceutical, Taiho Oncology und Cullinan Therapeutics haben erfolgreiche Ergebnisse aus ihrer REZILIENT1-Studie, einer Phase-1/2-Studie zu zipalertinib (CLN-081/TAS6417), bekannt gegeben. Die Studie erreichte ihren primären Endpunkt der Gesamtansprechrate bei Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC) mit EGFR Exon-20-Insertion-Mutationen, die zuvor behandelt wurden.
Das Sicherheitsprofil stimmte mit vorherigen Datenpräsentationen überein. Die Unternehmen planen, die vollständigen Ergebnisse auf einer bevorstehenden internationalen medizinischen Konferenz zu präsentieren und beabsichtigen, in der zweiten Hälfte des Jahres 2025 einen Antrag auf regulatorische Genehmigung bei der FDA zu stellen, vorbehaltlich von Gesprächen mit der Behörde.
- Phase 1/2 trial met primary endpoint of overall response rate
- Safety profile consistent with previous data
- Planned FDA submission in H2 2025
- None.
Insights
The successful Phase 2b results for zipalertinib mark a pivotal moment for Cullinan Therapeutics and its development partners. EGFR exon 20 insertion mutations occur in approximately 2-3% of NSCLC cases, representing a significant unmet medical need with effective treatment options currently available.
The achievement of the primary endpoint in previously treated patients is particularly noteworthy, as this population typically shows resistance to traditional EGFR inhibitors. While specific efficacy data is pending, meeting the overall response rate endpoint suggests clinically meaningful activity. The consistent safety profile is crucial, as existing treatments often face challenges with toxicity and adverse events.
From a market perspective, this positions Cullinan and its partners to potentially capture a share of the EGFR exon 20 insertion NSCLC market, currently served by only a few approved therapies like amivantamab and mobocertinib. The planned regulatory submission in H2 2025 could lead to potential commercialization by 2026, assuming standard FDA review timelines.
The partnership with Taiho Pharmaceutical and Taiho Oncology provides robust commercial infrastructure and expertise, particularly important given the specialized nature of the target patient population. For Cullinan, this represents a significant value inflection point, potentially transforming the company from a clinical-stage to a commercial-stage entity.
The upcoming detailed data presentation at a medical conference will be important for assessing zipalertinib's competitive positioning, particularly regarding efficacy and safety metrics compared to existing treatments. These results could significantly influence the drug's market potential and adoption rate among oncologists.
Full results from REZILIENT1 will be submitted for presentation at an upcoming international medical conference. Pending discussions with the
About the REZILIENT1 Trial
REZILIENT1 is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in patients with NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. The topline results obtained at this time are based on the Phase 2b part of this study. Preliminary results of REZILIENT1 have been published in the Journal of Clinical Oncology®.1
REZILIENT: Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors
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 being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the
About the EGFR exon 20 insertion mutations
NSCLC is a common form of lung cancer and up to
About Taiho Pharmaceutical Co., Ltd. (
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (https://www.otsuka.com/en/), is an R&D-driven specialty pharma focusing on the fields of oncology and immune-related diseases. Its corporate philosophy takes the form of a pledge: "We strive to improve human health and contribute to a society enriched by smiles." In the field of oncology, in particular, Taiho Pharmaceutical is known as a leading company in
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
For more information, visit https://www.taihooncology.com/, 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 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 plan and timeline of zipalertinib 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.
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: https://ascopubs.org/doi/full/10.1200/JCO.23.00152. Last accessed: January 2025.
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: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247620. Last accessed: January 2025.
Contacts
Taiho Pharmaceutical Co., Ltd.
Junko Onishi
+81-80-1009-7683
junn-onishi@taiho.co.jp
Taiho Oncology
Leigh Labrie
+ 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
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