HUTCHMED Completes Patient Enrollment of a Phase II Registration Study of Savolitinib in Gastric Cancer in China
HUTCHMED has completed patient enrollment for the registration phase of its Phase II trial evaluating savolitinib in gastric cancer patients with MET amplification. The single-arm, multi-center study enrolled 64 patients to assess the drug's efficacy in treating gastric or gastroesophageal junction adenocarcinoma.
Interim results showed promising outcomes with a 45% objective response rate (ORR) confirmed by Independent Review Committee, and 50% ORR in patients with high MET gene copy number. The 4-month duration of response rate was 85.7% with 5.5 months median follow-up.
The drug received Breakthrough Therapy Designation from China's NMPA for treating advanced gastric cancer patients who failed standard therapies. HUTCHMED plans to apply for marketing authorization in China by late 2025 if results remain positive.
HUTCHMED ha completato il reclutamento dei pazienti per la fase di registrazione del suo studio di Fase II che valuta savolitinib in pazienti con carcinoma gastrico con amplificazione del gene MET. Lo studio monocentrico e multicentrico ha arruolato 64 pazienti per valutare l'efficacia del farmaco nel trattamento dell'adenocarcinoma gastrico o della giunzione gastroesofagea.
I risultati preliminari hanno mostrato risultati promettenti con un tasso di risposta obiettiva (ORR) del 45% confermato da un Comitato di Revisione Indipendente, e un ORR del 50% nei pazienti con un alto numero di copie del gene MET. La durata della risposta a 4 mesi è stata dell'85,7% con un follow-up mediano di 5,5 mesi.
Il farmaco ha ricevuto la Designazione di Terapia Sperimentale Innovativa dalla NMPA cinese per il trattamento di pazienti con carcinoma gastrico avanzato che non hanno risposto alle terapie standard. HUTCHMED prevede di richiedere l'autorizzazione alla commercializzazione in Cina entro la fine del 2025, se i risultati rimarranno positivi.
HUTCHMED ha completado la inscripción de pacientes para la fase de registro de su ensayo de Fase II que evalúa savolitinib en pacientes con cáncer gástrico con amplificación del gen MET. El estudio, de un solo brazo y multicéntrico, inscribió a 64 pacientes para evaluar la eficacia del fármaco en el tratamiento del adenocarcinoma gástrico o de la unión gastroesofágica.
Los resultados interinos mostraron resultados prometedores con una tasa de respuesta objetiva (ORR) del 45% confirmada por un Comité de Revisión Independiente, y un ORR del 50% en pacientes con un alto número de copias del gen MET. La duración de la respuesta a 4 meses fue del 85,7% con un seguimiento medio de 5,5 meses.
El fármaco recibió la Designación de Terapia Innovadora por parte de la NMPA de China para el tratamiento de pacientes con cáncer gástrico avanzado que no respondieron a terapias estándar. HUTCHMED planea solicitar la autorización de comercialización en China a finales de 2025 si los resultados continúan siendo positivos.
HUTCHMED가 MET 증폭이 있는 위암 환자를 대상으로 한 2상 임상시험 등록 단계를 완료했습니다. 이 단일군 다기관 연구는 위 또는 위식도 접합부 선암 치료에서 savolitinib의 효능을 평가하기 위해 64명의 환자를 등록했습니다.
중간 결과는 독립 심사 위원회가 확인한 45%의 객관적 반응률(ORR)과 MET 유전자 복제 수가 높은 환자에서 50%의 ORR을 보여 유망한 결과를 나타냈습니다. 4개월 반응 지속률은 85.7%였으며 중앙값 추적 관찰 기간은 5.5개월이었습니다.
이 약물은 표준 치료에 실패한 진행성 위암 환자 치료를 위해 중국 국가약품감독관리국(NMPA)으로부터 혁신 치료제 지정을 받았습니다. HUTCHMED는 결과가 긍정적일 경우 2025년 말까지 중국에서 시판 허가를 신청할 계획입니다.
HUTCHMED a terminé le recrutement des patients pour la phase d’enregistrement de son essai de phase II évaluant savolitinib chez des patients atteints de cancer gastrique avec amplification du gène MET. L’étude monocentrique et multicentrique a inclus 64 patients afin d’évaluer l’efficacité du médicament dans le traitement de l’adénocarcinome gastrique ou de la jonction gastro-œsophagienne.
Les résultats intermédiaires ont montré des résultats prometteurs avec un taux de réponse objective (ORR) de 45% confirmé par un comité de revue indépendant, et un ORR de 50% chez les patients présentant un nombre élevé de copies du gène MET. La durée de la réponse à 4 mois était de 85,7% avec un suivi médian de 5,5 mois.
Le médicament a reçu la désignation de thérapie révolutionnaire de la NMPA chinoise pour le traitement des patients atteints de cancer gastrique avancé ayant échoué aux traitements standards. HUTCHMED prévoit de déposer une demande d’autorisation de mise sur le marché en Chine d’ici fin 2025 si les résultats restent positifs.
HUTCHMED hat die Patientenaufnahme für die Registrierungsphase seiner Phase-II-Studie zur Bewertung von savolitinib bei Magenkrebspatienten mit MET-Amplifikation abgeschlossen. Die einarmige, multizentrische Studie rekrutierte 64 Patienten, um die Wirksamkeit des Medikaments bei der Behandlung von Magen- oder gastroösophagealem Übergangsadenokarzinom zu beurteilen.
Zwischenergebnisse zeigten vielversprechende Resultate mit einer objektiven Ansprechrate (ORR) von 45%, bestätigt durch ein unabhängiges Überprüfungskomitee, und einer ORR von 50% bei Patienten mit hoher MET-Genkopienzahl. Die Ansprechdauer von 4 Monaten lag bei 85,7% bei einer medianen Nachbeobachtungszeit von 5,5 Monaten.
Das Medikament erhielt von der chinesischen NMPA die Breakthrough Therapy Designation für die Behandlung von Patienten mit fortgeschrittenem Magenkrebs, die auf Standardtherapien nicht angesprochen haben. HUTCHMED plant, bis Ende 2025 in China eine Marktzulassung zu beantragen, sofern die Ergebnisse weiterhin positiv bleiben.
- 45% objective response rate in Phase II trial
- 85.7% duration of response rate at 4 months
- Breakthrough Therapy Designation received from China's NMPA
- Strong safety profile with only one treatment discontinuation
- median follow-up time of only 5.5 months
- Multiple grade 3 or higher adverse events reported
Insights
HUTCHMED's savolitinib shows promising 45% response rate in MET-amplified gastric cancer with Breakthrough Designation, advancing toward potential 2025 submission.
The completion of patient enrollment in this Phase II registration study marks a significant milestone for savolitinib in treating MET-amplified gastric cancer. The interim efficacy data showing a
The enhanced
The safety profile appears manageable in this heavily pretreated population. Only one patient discontinued due to treatment-related adverse events (grade 4 liver function abnormality), which is noteworthy given the typical fragility of patients who have failed multiple treatment lines. The reported adverse events - decreased platelet count, hypersensitivity, anemia, neutropenia, and hepatic function abnormalities - are consistent with targeted therapies and appear clinically manageable.
The Breakthrough Therapy Designation from China's NMPA is significant, recognizing savolitinib's potential to address an important unmet need. Gastric cancer has particularly high prevalence in East Asia, making this development especially relevant for the Chinese market.
HUTCHMED advances savolitinib through key development milestone with strong interim data (45% ORR) and NMPA Breakthrough Designation for gastric cancer.
The completed enrollment of 64 patients in this Phase II registration study represents significant progress for one of HUTCHMED's key pipeline assets. The trial design is strategically important - this single-arm study with objective response rate as the primary endpoint suggests the company is pursuing an accelerated approval pathway in China based on response data alone, potentially enabling faster market access.
The interim efficacy signal is compelling for a targeted therapy in a pretreated population. The
The Breakthrough Therapy Designation from China's NMPA substantially enhances the regulatory outlook. This designation, granted for patients who have failed at least two lines of standard therapies, acknowledges the potential significant improvement over available treatments and may enable priority review.
The company's stated timeline of potentially filing for marketing authorization in late 2025 provides a clear regulatory pathway. The safety profile appears favorable for a cancer therapy, with only one treatment discontinuation due to adverse events, suggesting the drug could maintain quality of life while offering efficacy.
This targeted MET-amplification approach aligns with the evolving oncology landscape toward biomarker-selected therapies, positioning HUTCHMED's savolitinib as a potential important new option for gastric cancer patients in China who currently have few effective treatments after failing standard therapies.
HONG KONG and FLORHAM PARK, N.J., April 22, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed enrollment of the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification.
This clinical trial is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and tolerability of savolitinib in treating gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with MET amplification. Primary endpoint is objective response rate (“ORR”) evaluated by the Independent Review Committee (“IRC”) (RECIST 1.1). Secondary endpoints include progression free survival (PFS) and incidence of various adverse events (AE), among others. A total of 64 patients have been enrolled in the study. Further details may be found at clinicaltrials.gov using identifier NCT04923932.
As reported at the American Association for Cancer Research Annual Meeting, interim results from the study showed a
The China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation to savolitinib for the treatment of locally advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with MET amplification who have failed at least two lines of standard therapies. If positive, HUTCHMED may initiate plans to apply for marketing authorization of savolitinib for gastric cancer in China in late 2025.
About Gastric Cancer with MET Amplification
MET-driven gastric cancer has a very poor prognosis.1 It is estimated that MET amplification accounts for approximately 4
About Savolitinib
Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an essential role in normal cell development.5 Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.
Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023.
It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.
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 around the world including 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 savolitinib, the further clinical development for savolitinib, its expectations as to whether any studies on savolitinib 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 savolitinib, 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 savolitinib 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
| Investor Enquiries | +852 2121 8200 / ir@hutch-med.com |
| Media Enquiries | |
| FTI Consulting – | +44 20 3727 1030 / HUTCHMED@fticonsulting.com |
| Ben Atwell / Alex Shaw | +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) |
| Brunswick – Zhou Yi | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Panmure Liberum | Nominated Advisor and Joint Broker |
| Atholl Tweedie / Freddy Crossley / Rupert Dearden | +44 20 7886 2500 |
| HSBC | Joint Broker |
| Simon Alexander / Alina Vaskina / Arnav Kapoor | +44 20 7991 8888 |
| Cavendish | Joint Broker |
| Geoff Nash / Nigel Birks | +44 20 7220 0500 |
1 Catenacci DV, Ang A, Liao WL, et al. MET tyrosine kinase receptor expression and amplification as prognostic biomarkers of survival in gastroesophageal adenocarcinoma. Cancer. 2017;123(6):1061-1070. doi:10.1002/cncr.30437
2 Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-044
3 Van Cutsem E, Karaszewska B, Kang YK, et al. A Multicenter Phase II Study of AMG 337 in Patients with MET-Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma and Other MET-Amplified Solid Tumors. Clin Cancer Res. 2019;25(8):2414-2423. doi:10.1158/1078-0432.CCR-18-1337
4 Global Cancer Observatory. China Fact Sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed April 7, 2025.
5 Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074).
FAQ
What are the interim results of HUTCHMED's savolitinib Phase II trial for gastric cancer (HCM)?
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