Taiho Oncology and Cullinan Therapeutics Present Data on Zipalertinib at the IASLC 2025 World Conference on Lung Cancer
Cullinan Therapeutics (NASDAQ:CGEM) and Taiho Oncology presented new data from two clinical trials of zipalertinib at the IASLC 2025 World Conference on Lung Cancer. The REZILIENT1 trial showed promising results in NSCLC patients with EGFR ex20ins mutations who previously received amivantamab, achieving a 27.4% confirmed objective response rate with 8.5 months median duration of response.
In the REZILIENT2 trial, zipalertinib demonstrated efficacy in patients with uncommon non-ex20ins EGFR mutations, with a 30% confirmed objective response rate and 7.75 months median duration of response. Notably, treatment-na茂ve patients showed a significantly higher response rate of 62.5% compared to 21.9% in previously treated patients.
Both trials demonstrated a manageable safety profile for zipalertinib, with most adverse events being grade 1 or 2.
Cullinan Therapeutics (NASDAQ:CGEM) e Taiho Oncology hanno presentato nuovi dati di due studi clinici su zipalertinib al Congresso Mondiale sul Cancro del Polmone IASLC 2025. Lo studio REZILIENT1 ha mostrato risultati promettenti in pazienti con NSCLC portatori di mutazioni EGFR ex20ins precedentemente trattati con amivantamab, con un tasso di risposta oggettiva confermata del 27,4% e una durata mediana della risposta di 8,5 mesi.
Nel REZILIENT2, zipalertinib ha mostrato efficacia in pazienti con mutazioni EGFR non comuni diverse da ex20ins, con un tasso di risposta oggettiva confermata del 30% e una durata mediana della risposta di 7,75 mesi. Da notare che i pazienti non precedentemente trattati hanno registrato un tasso di risposta molto pi霉 alto, pari al 62,5%, rispetto al 21,9% nei pazienti gi脿 trattati.
Entrambi gli studi hanno evidenziato un profilo di sicurezza gestibile per zipalertinib, con la maggior parte degli eventi avversi di grado 1 o 2.
Cullinan Therapeutics (NASDAQ:CGEM) y Taiho Oncology presentaron nuevos datos de dos ensayos cl铆nicos con zipalertinib en la Conferencia Mundial sobre C谩ncer de Pulm贸n IASLC 2025. El ensayo REZILIENT1 mostr贸 resultados prometedores en pacientes con NSCLC con mutaciones EGFR ex20ins previamente tratados con amivantamab, alcanzando una tasa de respuesta objetiva confirmada del 27,4% y una duraci贸n mediana de la respuesta de 8,5 meses.
En el REZILIENT2, zipalertinib demostr贸 eficacia en pacientes con mutaciones EGFR no comunes distintas de ex20ins, con una tasa de respuesta objetiva confirmada del 30% y una duraci贸n mediana de la respuesta de 7,75 meses. Cabe destacar que los pacientes sin tratamiento previo mostraron una tasa de respuesta considerablemente mayor, del 62,5%, frente al 21,9% en pacientes previamente tratados.
Ambos ensayos mostraron un perfil de seguridad manejable para zipalertinib, con la mayor铆a de los eventos adversos de grado 1 o 2.
Cullinan Therapeutics (NASDAQ:CGEM)鞕� Taiho Oncology電� IASLC 2025 靹戈硠 韽愳晹 頃欗殞鞐愳劀 zipalertinib鞚� 霊� 鞛勳儊鞁滍棙 鞁犼窚 雿办澊韯半ゼ 氚滍憸頄堨姷雼堧嫟. REZILIENT1 鞁滍棙鞚� amivantamab鞙茧 旃橂氚涭潃 氤戨牓鞚� 鞛堧姅 EGFR ex20ins 氤�鞚� 牍勳唽靹疙彫韽愳晹(NSCLC) 頇橃瀽鞐愳劀 鞙犽頃� 瓴瓣臣毳� 氤挫榾鞙茧┌, 頇曥霅� 臧濌磤鞝� 氚橃潙毳� 27.4%瓿� 氚橃潙 歆�靻� 欷戩暀臧� 8.5臧滌洈鞚� 旮半頄堨姷雼堧嫟.
REZILIENT2 鞁滍棙鞐愳劀電� ex20ins臧� 鞎勲媽 霌滊 EGFR 氤�鞚措ゼ 臧�歆� 頇橃瀽霌れ棎靹� zipalertinib鞚� 鞙犿毃靹膘澊 鞛呾霅橃棃瓿�, 頇曥霅� 臧濌磤鞝� 氚橃潙毳� 30%瓿� 氚橃潙 歆�靻� 欷戩暀臧� 7.75臧滌洈鞚� 氤挫榾鞀惦媹雼�. 韸鬼瀳 旃橂 瓴巾棙鞚� 鞐嗠姅 頇橃瀽鞚� 氚橃潙毳犾澊 62.5%搿� 鞚挫爠 旃橂毳� 氚涭潃 頇橃瀽甑办潣 21.9%氤措嫟 頉敩 雴掛晿鞀惦媹雼�.
霊� 鞁滍棙 氇憪 zipalertinib鞚� 鞎堨爠靹� 頂勲韺岇澕鞚� 甏�毽� 臧�電ロ暔鞚� 氤挫棳欤检棃瓿�, 雽�攵�攵勳潣 鞚挫儊氚橃潙鞚� 1旮� 霕愲姅 2旮夓棎 頃措嫻頄堨姷雼堧嫟.
Cullinan Therapeutics (NASDAQ:CGEM) et Taiho Oncology ont pr茅sent茅 de nouvelles donn茅es de deux essais cliniques sur le zipalertinib lors de la conf茅rence mondiale IASLC 2025 sur le cancer du poumon. L'essai REZILIENT1 a montr茅 des r茅sultats prometteurs chez des patients atteints de NSCLC porteurs de mutations EGFR ex20ins ayant d茅j脿 re莽u de l'amivantamab, avec un taux de r茅ponse objective confirm茅 de 27,4% et une dur茅e m茅diane de r茅ponse de 8,5 mois.
Dans l'essai REZILIENT2, le zipalertinib a d茅montr茅 une activit茅 chez des patients pr茅sentant des mutations EGFR peu fr茅quentes hors ex20ins, avec un taux de r茅ponse objective confirm茅 de 30% et une dur茅e m茅diane de r茅ponse de 7,75 mois. Notamment, les patients non trait茅s auparavant ont affich茅 un taux de r茅ponse nettement sup茅rieur de 62,5% contre 21,9% chez les patients pr茅trait茅s.
Les deux essais ont montr茅 un profil de s茅curit茅 g茅rable pour le zipalertinib, la majorit茅 des 茅v茅nements ind茅sirables 茅tant de grade 1 ou 2.
Cullinan Therapeutics (NASDAQ:CGEM) und Taiho Oncology stellten neue Daten aus zwei klinischen Studien zu zipalertinib auf der IASLC World Conference on Lung Cancer 2025 vor. Die REZILIENT1-Studie zeigte vielversprechende Ergebnisse bei NSCLC-Patienten mit EGFR ex20ins-Mutationen, die zuvor Amivantamab erhalten hatten, mit einer best盲tigten objektiven Ansprechrate von 27,4% und einer medianen Ansprechdauer von 8,5 Monaten.
In der REZILIENT2-Studie zeigte zipalertinib Wirksamkeit bei Patienten mit seltenen, nicht-ex20ins EGFR-Mutationen, mit einer best盲tigten objektiven Ansprechrate von 30% und einer medianen Ansprechdauer von 7,75 Monaten. Bemerkenswert: unbehandelte Patienten erzielten eine deutlich h枚here Ansprechrate von 62,5% gegen眉ber 21,9% bei vorbehandelten Patienten.
Beide Studien zeigten ein gut handhabbares Sicherheitsprofil f眉r zipalertinib, wobei die meisten Nebenwirkungen Grad 1 oder 2 waren.
- Confirmed ORR of 27.4% in REZILIENT1 trial with 8.5 months median duration of response
- High disease control rate of 84.5% in REZILIENT1 study
- Strong efficacy in treatment-na茂ve patients with 62.5% ORR in REZILIENT2 trial
- Manageable safety profile with majority of adverse events being grade 1 or 2
- Lower ORR (20.0%) in patients with prior amivantamab and other ex20ins-targeted therapy
- Some serious adverse events including grade 鈮�3 anemia (15.5%) and pneumonia (10.7%)
Insights
Zipalertinib shows meaningful efficacy in EGFR-mutated lung cancer after prior treatment failure, bolstering CGEM's clinical pipeline with manageable safety profile.
The updated data from Cullinan's zipalertinib trials represents encouraging progress in addressing significant unmet needs in NSCLC. The REZILIENT1 trial results demonstrate notable efficacy in patients previously treated with amivantamab, with an overall objective response rate (ORR) of
What stands out clinically is zipalertinib's activity in patients with brain metastases, showing a
The REZILIENT2 data in uncommon non-ex20ins EGFR mutations is similarly encouraging, with treatment-na茂ve patients showing a dramatically higher ORR (
From a safety perspective, the profile appears manageable and consistent with other EGFR inhibitors. Most adverse events were grade 1-2, though monitoring for paronychia, skin toxicities, and pneumonitis will be important in clinical practice. The
These results position zipalertinib as a potentially valuable addition to the treatment landscape for these molecularly-defined NSCLC populations with limited therapeutic options. The data support continued development, with further follow-up needed to assess durability of responses and long-term safety.
Zipalertinib's positive data in difficult-to-treat lung cancer populations strengthens Cullinan's pipeline value and partnership with Taiho.
The clinical data released by Cullinan Therapeutics represents a significant milestone in their development of zipalertinib and strengthens their position in the targeted oncology space. The efficacy results, particularly in post-amivantamab patients with EGFR ex20ins mutations, demonstrate that zipalertinib addresses a growing market of patients who progress after initial targeted therapy.
What's particularly valuable from a commercial perspective is the differentiated clinical profile across multiple patient segments. The
For the uncommon non-ex20ins EGFR mutations cohort, the striking difference in response rates between treatment-na茂ve (
The partnership with Taiho Oncology provides Cullinan with an experienced commercialization partner while potentially preserving significant economics. The safety profile appears competitive with existing EGFR inhibitors, with manageable toxicities that should not impede regulatory pathways or commercial adoption.
These results likely strengthen Cullinan's pipeline valuation, as zipalertinib demonstrates potential to address multiple segments of the EGFR-mutated NSCLC market with differentiated efficacy. The company is well-positioned to advance zipalertinib toward potential regulatory submissions if these response rates are maintained with longer follow-up.
- Updated efficacy and safety data to be presented from the REZILIENT1 trial of zipalertinib from the cohort of patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who were previously treated with amivantamab
- Preliminary clinical efficacy and safety data to be presented from the cohort of patients with uncommon non-ex20ins EGFR mutations in the REZILIENT2 trial of zipalertinib
A mini 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 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,
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):
As of the June 2025 data cutoff, 84 post-amivantamab patients were enrolled in REZILIENT1 and received at least one dose of 100 mg zipalertinib. Patients had received a median of 3 prior lines of therapy, and
With follow-up of more than 9 months, zipalertinib demonstrated:
- In all patients (n=84), confirmed objective response rate (ORR) was
27.4% with median duration of response (mDOR) of 8.5 months, and the disease control rate (DCR) was84.5% . - In patients with听prior amivantamab only听(n=54), ORR was
31.5% with mDOR of 9.5 months, and the DCR was87.0% . - In patients with听prior amivantamab听and other ex20ins-targeted therapy (n=30), ORR was
20.0% with mDOR of 8.3 months, and the DCR was80.0% . - In patients with听brain metastases who received prior amivantamab only听(n=31), the systemic ORR was
29% .
Summary of Safety and Tolerability听
The safety analysis population included all post-amivantamab patients in REZILIENT1 who received at least one dose of 100 mg zipalertinib (n=84). The results showed that zipalertinib 100 mg twice daily demonstrated a manageable safety profile in patients who progressed on prior chemotherapy and amivantamab with no new safety signals.
The most common treatment-emergent adverse events (TEAEs, all-grade) were paronychia (
The most common grade 鈮�3 TEAEs were anemia (
Authors reported results from the REZILIENT2 study of听zipalertinib from the cohort of patients with NSCLC harboring uncommon non-exon 20 insertion EGFR mutations2听
Summary of Preliminary Efficacy 鈥揵y Investigator
As of the March 2025 data cutoff, 40 patients were enrolled in the REZILIENT2 Cohort D and received zipalertinib 100 mg orally twice daily. Previously treated patients had received a median of 2 prior lines of therapy, and
As of the data cut-off, zipalertinib demonstrated:
- In the overall efficacy population (n=40), confirmed ORR was
30% with a mDOR of 7.75 months, and the disease control rate (DCR) was70% . - In the treatment-na茂ve population (n=8), ORR was significantly higher (
62.5% ) compared to the previously treated patient population (n=32, ORR21.9% ).
Summary of Preliminary Safety and Tolerability听
The safety analysis population included all REZILIENT2 patients in Cohort D who received at least one dose of 100 mg zipalertinib (n=40). The results showed that zipalertinib 100 mg twice daily demonstrated a manageable safety and tolerability profile with no new safety signals.
The most common treatment-related adverse events (TRAEs, all-grade) were paronychia (
The most common grade 鈮�3 TRAEs were paronychia (
About REZILIENT1
REZILIENT1 (Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial () to evaluate efficacy and safety of zipalertinib in adult patients with advanced or metastatic NSCLC harboring EGFR ex20ins mutations who have received prior therapy. Patients were treated with oral zipalertinib 100 mg twice daily. 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 REZILIENT2
REZILIENT2 is a Phase 2b clinical trial (), evaluating zipalertinib in patients with locally advanced/metastatic NSCLC harboring ex20ins and uncommon single or compound EGFR mutations. Patients were treated with oral zipalertinib 100 mg twice daily. The primary endpoint was ORR and confirmed per investigator-assessed Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 and the secondary endpoints included DOR, DCR and safety.
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 ex20ins 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
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 , and follow us on and
Taiho Oncology and the Taiho Oncology logo are registered trademarks of Taiho Pharmaceutical Co., Ltd.
About Cullinan Therapeutics
听(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听, and follow us on听听and听.
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.
Contacts
Taiho Oncology
Leigh Labrie
(609) 664-9878
[email protected]
Cullinan Therapeutics
Investors听
Nick Smith
+1 401.241.3516
[email protected]
Media听
Rose Weldon听听听
+1 215.801.7644听听听
[email protected]
References:
1.听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
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FAQ
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