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 Therapeutics (NASDAQ: CGEM) announced that results from their REZILIENT1 study of zipalertinib in non-small cell lung cancer (NSCLC) patients will be presented at the 2025 ASCO Annual Meeting. The Phase 2b trial, which met its primary endpoint of overall response rate, evaluated zipalertinib monotherapy in patients with advanced or metastatic EGFR exon 20 insertion mutations who progressed after prior platinum-based chemotherapy.
The study demonstrated clinically meaningful efficacy and a manageable safety profile in patients previously treated with platinum-based chemotherapy, including those treated with amivantamab. Dr. Helena A. Yu from Memorial Sloan Kettering Cancer Center will present the findings on June 1, 2025. The company will also host an investor event featuring Dr. Danny Nguyen from City of Hope National Medical Center to discuss the data.
Cullinan Therapeutics (NASDAQ: CGEM) ha annunciato che i risultati dello studio REZILIENT1 sul zipalertinib in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) saranno presentati al Meeting Annuale ASCO 2025. Lo studio di Fase 2b, che ha raggiunto l'endpoint primario del tasso di risposta globale, ha valutato la monoterapia con zipalertinib in pazienti con mutazioni di inserzione nell'esone 20 di EGFR in fase avanzata o metastatica, che avevano progressione dopo chemioterapia a base di platino.
Lo studio ha dimostrato un'efficacia clinicamente significativa e un profilo di sicurezza gestibile in pazienti precedentemente trattati con chemioterapia a base di platino, inclusi quelli trattati con amivantamab. La dottoressa Helena A. Yu del Memorial Sloan Kettering Cancer Center presenterà i risultati il 1° giugno 2025. L'azienda organizzerà inoltre un evento per investitori con la partecipazione del dottor Danny Nguyen del City of Hope National Medical Center per discutere i dati.
Cullinan Therapeutics (NASDAQ: CGEM) anunció que los resultados de su estudio REZILIENT1 sobre zipalertinib en pacientes con cáncer de pulmón no microcítico (NSCLC) serán presentados en la Reunión Anual ASCO 2025. El ensayo de fase 2b, que cumplió su objetivo principal de tasa de respuesta global, evaluó la monoterapia con zipalertinib en pacientes con mutaciones de inserción en el exón 20 de EGFR en estado avanzado o metastásico que progresaron tras quimioterapia previa basada en platino.
El estudio demostró una eficacia clínicamente significativa y un perfil de seguridad manejable en pacientes previamente tratados con quimioterapia basada en platino, incluidos aquellos tratados con amivantamab. La Dra. Helena A. Yu del Memorial Sloan Kettering Cancer Center presentará los hallazgos el 1 de junio de 2025. La compañía también organizará un evento para inversores con el Dr. Danny Nguyen del City of Hope National Medical Center para discutir los datos.
Cullinan Therapeutics (NASDAQ: CGEM)는 비소세포폐암(NSCLC) 환자를 대상으로 한 zipalertinib의 REZILIENT1 연구 결과를 2025년 ASCO 연례회의에서 발표할 예정이라고 밝혔습니다. 2b상 임상시험은 전체 반응률이라는 주요 평가 지표를 충족했으며, 이전에 백금 기반 화학요법을 받은 진행성 또는 전이성 EGFR 엑손 20 삽입 돌연변이 환자들을 대상으로 zipalertinib 단독요법을 평가했습니다.
이 연구는 백금 기반 화학요법을 받은 환자, 특히 amivantamab 치료를 받은 환자들에서 임상적으로 의미 있는 효능과 관리 가능한 안전성 프로필을 입증했습니다. Memorial Sloan Kettering Cancer Center의 Helena A. Yu 박사가 2025년 6월 1일 연구 결과를 발표할 예정입니다. 또한 회사는 City of Hope National Medical Center의 Danny Nguyen 박사와 함께 투자자 행사를 개최하여 데이터를 논의할 계획입니다.
Cullinan Therapeutics (NASDAQ : CGEM) a annoncé que les résultats de leur étude REZILIENT1 sur le zipalertinib chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) seront présentés lors de la réunion annuelle ASCO 2025. L'essai de phase 2b, qui a atteint son critère principal de taux de réponse global, a évalué la monothérapie par zipalertinib chez des patients présentant des mutations par insertion de l'exon 20 de l'EGFR avancées ou métastatiques, ayant progressé après une chimiothérapie antérieure à base de platine.
L'étude a démontré une efficacité cliniquement significative et un profil de sécurité gérable chez des patients préalablement traités par chimiothérapie à base de platine, y compris ceux traités par amivantamab. La Dre Helena A. Yu du Memorial Sloan Kettering Cancer Center présentera les résultats le 1er juin 2025. L'entreprise organisera également un événement pour les investisseurs avec le Dr Danny Nguyen du City of Hope National Medical Center afin de discuter des données.
Cullinan Therapeutics (NASDAQ: CGEM) gab bekannt, dass die Ergebnisse ihrer REZILIENT1-Studie zu Zipalertinib bei Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC) auf dem ASCO-Jahrestreffen 2025 vorgestellt werden. Die Phase-2b-Studie, die ihren primären Endpunkt der Gesamtansprechrate erreichte, untersuchte Zipalertinib-Monotherapie bei Patienten mit fortgeschrittenen oder metastasierten EGFR Exon 20 Insertion-Mutationen, die nach vorheriger platinhaltiger Chemotherapie progredient waren.
Die Studie zeigte klinisch relevante Wirksamkeit und ein handhabbares Sicherheitsprofil bei zuvor mit platinhaltiger Chemotherapie behandelten Patienten, einschließlich solcher, die mit Amivantamab behandelt wurden. Dr. Helena A. Yu vom Memorial Sloan Kettering Cancer Center wird die Ergebnisse am 1. Juni 2025 präsentieren. Das Unternehmen wird außerdem eine Investorenveranstaltung mit Dr. Danny Nguyen vom City of Hope National Medical Center abhalten, um die Daten zu besprechen.
- Phase 2b trial met primary endpoint of overall response rate
- Demonstrated clinically meaningful efficacy in previously treated patients
- Showed manageable safety profile in target population
- None.
Insights
Zipalertinib met its primary endpoint in Phase 2b NSCLC trial for patients with EGFR exon 20 mutations, showing potential in this difficult-to-treat population.
The REZILIENT1 trial represents a meaningful development for patients with non-small cell lung cancer harboring EGFR exon 20 insertion mutations. This specific mutation subtype affects approximately 2-3% of NSCLC patients and has historically been associated with poor prognosis and treatment options.
What stands out in this announcement is that zipalertinib demonstrated efficacy in a particularly challenging population - patients who had already progressed after platinum-based chemotherapy, including those previously treated with amivantamab (the first FDA-approved targeted therapy for this mutation). This suggests potential utility as a sequential therapy option, which is critically important in managing this aggressive cancer type.
The selection for an oral presentation at ASCO is significant, as these slots are typically reserved for studies with more impactful findings compared to poster presentations. While the press release doesn't disclose specific efficacy metrics, the statement that the study met its primary endpoint of overall response rate indicates the drug achieved predetermined efficacy thresholds.
For context, current approved therapies for this patient population have shown modest efficacy - amivantamab with response rates of approximately 40% and mobocertinib around 28%, though both come with notable toxicity profiles. The mention of zipalertinib's "manageable safety profile" suggests it might offer a favorable therapeutic index, though we'll need to see the full safety data presented at ASCO to understand its complete clinical profile.
Positive Phase 2b results for zipalertinib strengthen Cullinan's clinical pipeline, with upcoming ASCO presentation potentially increasing investor interest.
Meeting the primary endpoint in the Phase 2b REZILIENT1 trial represents a significant clinical milestone for Cullinan Therapeutics' lead candidate zipalertinib. For a clinical-stage biotech company with a
The selection for an oral presentation at ASCO adds scientific credibility to these findings, as such presentation slots undergo competitive peer review. Additionally, the company's decision to hold a concurrent investor event signals management's confidence in the importance of these results to their business trajectory.
The EGFR exon 20 insertion mutation space, while representing a niche segment of NSCLC, has attracted significant industry attention with multiple competitive programs in development. The current treatment landscape includes amivantamab (Rybrevant) and mobocertinib (Exkivity), but there remains substantial room for improvement in both efficacy and tolerability.
Particularly noteworthy is zipalertinib's activity in patients previously treated with amivantamab, as this positions the drug as a potential sequential therapy option. This could expand its clinical utility beyond just competing with existing treatments.
While specific data points aren't disclosed in this announcement, the clear statement that the primary endpoint was met provides a solid foundation for the upcoming presentation. The full dataset presented at ASCO will be critical for understanding zipalertinib's potential competitive positioning and path to market in this indication.
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) -- Cullinan Therapeutics, Inc. (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 (nsmith@cullinantx.com). A webcast will be available via the events page of the Company’s investor relations website at https://cullinantherapeutics.com/events-and-presentations/.
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
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 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
nsmith@cullinantx.com
Media
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com
FAQ
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