HUTCHMED Announces that it has Completed Enrollment of a Phase II Registration Study of Fanregratinib (HMPL-453) for Intrahepatic Cholangiocarcinoma in China
HUTCHMED has completed enrollment for a Phase II registration study of fanregratinib (HMPL-453) targeting intrahepatic cholangiocarcinoma (IHCC) patients with FGFR2 fusion/rearrangement in China. The single-arm, multi-center, open-label trial has enrolled 87 patients since March 2023.
The study's primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS). Topline results are expected around the end of 2025, and favorable outcomes could lead to a New Drug Application submission to China's National Medical Products Administration (NMPA).
HUTCHMED ha completato l'arruolamento per uno studio di registrazione di Fase II su fanregratinib (HMPL-453) che mira a pazienti con colangiocarcinoma intraepatico (IHCC) con fusione/ristrutturazione di FGFR2 in Cina. Lo studio, di braccio singolo, multicentrico e in aperto, ha arruolato 87 pazienti da marzo 2023.
L'obiettivo primario dello studio è il tasso di risposta obiettiva (ORR), con obiettivi secondari che includono la sopravvivenza libera da progressione (PFS), il tasso di controllo della malattia (DCR), la durata della risposta (DoR) e la sopravvivenza globale (OS). I risultati preliminari sono attesi verso la fine del 2025, e risultati favorevoli potrebbero portare a una richiesta di registrazione di un nuovo farmaco presso l'Amministrazione Nazionale dei Prodotti Medici della Cina (NMPA).
HUTCHMED ha completado la inscripción para un estudio de registro de Fase II de fanregratinib (HMPL-453) dirigido a pacientes con colangiocarcinoma intrahepático (IHCC) con fusión/reorganización de FGFR2 en China. El ensayo de brazo único, multicéntrico y abierto ha inscrito a 87 pacientes desde marzo de 2023.
El objetivo primario del estudio es la tasa de respuesta objetiva (ORR), con objetivos secundarios que incluyen la supervivencia libre de progresión (PFS), la tasa de control de la enfermedad (DCR), la duración de la respuesta (DoR) y la supervivencia global (OS). Se esperan resultados preliminares hacia finales de 2025, y resultados favorables podrían conducir a una solicitud de nuevo fármaco ante la Administración Nacional de Productos Médicos de China (NMPA).
HUTCHMED는 중국에서 FGFR2 융합/재배열을 가진 간내 담관암(IHCC) 환자를 대상으로 하는 fanregratinib (HMPL-453)의 2상 등록 연구에 대한 모집을 완료했습니다. 이 단일 군, 다기관, 개방형 시험은 2023년 3월 이후 87명의 환자를 모집했습니다.
연구의 주요 목표는 객관적 반응률(ORR)이며, 이차 목표에는 무진행 생존 기간(PFS), 질병 조절률(DCR), 반응 지속 기간(DoR), 전체 생존 기간(OS)이 포함됩니다. 주요 결과는 2025년 말경에 예상되며, 긍정적인 결과는 중국 국가 의약품 관리국(NMPA)에 새로운 약물 신청을 제출하는 데 기여할 수 있습니다.
HUTCHMED a terminé le recrutement pour une étude d'enregistrement de Phase II sur fanregratinib (HMPL-453) visant des patients atteints de cholangiocarcinome intra-hépatique (IHCC) avec fusion/réarrangement de FGFR2 en Chine. L'essai à bras unique, multicentrique et en ouvert a recruté 87 patients depuis mars 2023.
Le critère principal de l'étude est le taux de réponse objective (ORR), avec des critères secondaires incluant la survie sans progression (PFS), le taux de contrôle de la maladie (DCR), la durée de réponse (DoR) et la survie globale (OS). Les résultats préliminaires sont attendus vers la fin de 2025, et des résultats favorables pourraient conduire à une demande d'autorisation de mise sur le marché auprès de l'Administration nationale des produits médicaux de Chine (NMPA).
HUTCHMED hat die Rekrutierung für eine Phase-II-Registrierungsstudie zu fanregratinib (HMPL-453) abgeschlossen, die sich an Patienten mit intrahepatischem Cholangiokarzinom (IHCC) mit FGFR2-Fusion/Umbau in China richtet. Die einarmige, multizentrische, offene Studie hat seit März 2023 87 Patienten rekrutiert.
Der primäre Endpunkt der Studie ist die objektive Ansprechrate (ORR), während sekundäre Endpunkte das progressionsfreie Überleben (PFS), die Krankheitskontrollrate (DCR), die Ansprechdauer (DoR) und das Gesamtüberleben (OS) umfassen. Die vorläufigen Ergebnisse werden gegen Ende 2025 erwartet, und günstige Ergebnisse könnten zu einem Antrag auf Zulassung eines neuen Medikaments bei der Nationalen Arzneimittelbehörde Chinas (NMPA) führen.
- Completed enrollment of 87 patients for Phase II registration study
- Potential New Drug Application submission to China NMPA if results are favorable
- Results not expected until end of 2025
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 06, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma (“IHCC”) patients with fibroblast growth factor receptor (“FGFR”)2 fusion/rearrangement.
The study is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced IHCC patients with FGFR2 fusion/rearrangement. Primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR) and overall survival (OS). A total of 87 patients were enrolled into the registration phase of the study. Additional details may be found at clinicaltrials.gov using identifier NCT04353375.
The first patient received the first dose in March 2023 and HUTCHMED expects to announce topline results from the study around the end of 2025. If favorable, the results could enable a New Drug Application submission to China’s National Medical Products Administration (NMPA).
About Fanregratinib
Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings.
HUTCHMED currently retain all rights to fanregratinib worldwide.
About IHCC with FGFR2 Fusion/Rearrangement
IHCC is one of the subtypes of primary bile duct cancer. In China, an estimated 61,900 newly diagnosed IHCC occurred in 2015 and the overall IHCC incidence increased by
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of fanregratinib, the further clinical development for fanregratinib, its expectations as to whether any studies on fanregratinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fanregratinib, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of fanregratinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
CONTACTS
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| Media Enquiries | |
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| Panmure Liberum | Nominated Advisor and Joint Broker |
| Atholl Tweedie / Freddy Crossley / Rupert Dearden | +44 20 7886 2500 |
| HSBC | Joint Broker |
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REFERENCES
1 An L, Zheng R, Zhang S, et al. Hepatocellular carcinoma and intrahepatic cholangiocarcinoma incidence between 2006 and 2015 in China: estimates based on data from 188 population-based cancer registries. Hepatobiliary Surg Nutr. 2023 Feb 28;12(1):45-55.
2 Arai Y, Totoki Y, Hosoda F, et al. Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma. Hepatology. 2014;59:1427–34.
3 Nakamura H, Arai Y, Totoki Y, et al. Genomic spectra of biliary tract cancer. Nat Genet. 2015;47:1003–10.
FAQ
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