HUTCHMED Completes Enrollment for Savolitinib Phase II Trial in Gastric Cancer
Overview of Clinical Trial
HUTCHMED (China) Limited has announced the completion of patient enrollment for the registration phase of its Phase II trial focusing on savolitinib, aimed at gastric cancer patients with MET amplification. This multi-center, open-label study seeks to assess the efficacy and safety of savolitinib, with the primary endpoint being the objective response rate (ORR). A total of 64 patients have been enrolled in this trial. Early results indicated a 45% ORR, alongside a significant duration of response, although common treatment-related adverse events were also reported. Savolitinib is recognized with Breakthrough Therapy Designation from China’s National Medical Products Administration for patients who have not responded to prior treatments. If results are favorable, HUTCHMED plans to pursue marketing authorization for savolitinib in China by late 2025. This selective MET tyrosine kinase inhibitor is already approved for treating non-small cell lung cancer in the region.
Potential Benefits of the Trial
- The completion of enrollment for the Phase II trial signifies HUTCHMED’s progress in developing treatment options for gastric cancer.
- Interim findings revealing a 45% ORR suggest that savolitinib could be effective for gastric cancer patients with MET amplification.
- Recognition from the NMPA through Breakthrough Therapy Designation highlights the drug’s potential to fulfill unmet medical needs.
- Strong interim results could enhance HUTCHMED’s competitive position in the oncology therapeutics market if the trial continues to show promising outcomes.
Challenges and Concerns
- With only 64 patients enrolled, there may be questions regarding the overall robustness and applicability of the trial findings.
- Interim data also point to a notable proportion of patients experiencing grade 3 or higher treatment-related adverse events, raising safety concerns about savolitinib.
Frequently Asked Questions
What is the Phase II trial of savolitinib focused on?
The trial assesses the efficacy, safety, and tolerability of savolitinib in patients with gastric cancer who have MET amplification.
How many patients are enrolled in the savolitinib trial?
A total of 64 patients have been enrolled in the Phase II trial for savolitinib.
What are the primary endpoints of the trial?
The primary endpoint is the objective response rate (ORR), as evaluated by the Independent Review Committee (IRC).
What is the significance of MET amplification in gastric cancer?
Approximately 4-6% of gastric cancer patients have MET amplification, which is associated with a poor prognosis.
What milestone is HUTCHMED targeting for late 2025?
If the trial results are positive, HUTCHMED may apply for marketing authorization of savolitinib for gastric cancer in China.
Disclaimer: This summary was generated based on a press release distributed by GlobeNewswire. There may be inaccuracies in this AI-generated content. For the complete release, click here.
Institutional Investor Activity in HUTCHMED
In the latest quarter, 23 institutional investors have added shares of $HCM while 35 have reduced their positions.
Here are some notable movements:
- UBS GROUP AG increased their holdings by 274,090 shares (+264.5%), valued at approximately $3,949,636.
- ALLIANZ ASSET MANAGEMENT GMBH decreased shares by 202,731 (-15.3%), totaling an estimated $2,921,353.
- SCHRODER INVESTMENT MANAGEMENT GROUP cut their shares by 154,726 (-5.3%), valued around $2,229,601.
- ACADIAN ASSET MANAGEMENT LLC reduced their holdings by 145,901 shares (-86.5%), with an estimated value of $2,102,433.
- MILLENNIUM MANAGEMENT LLC lowered their portfolio by 100,366 shares (-32.4%), estimated at $1,446,274.
- MORGAN STANLEY has also decreased holdings by 70,280 shares (-72.6%), amounting to approximately $1,012,734.
- D. E. SHAW & CO., INC. reduced their shares by 51,734 (-55.5%), for an estimated $745,486.
To track the portfolio activity of hedge funds, visit Quiver Quantitative’s institutional holdings dashboard.
Full Press Release
HONG KONG and FLORHAM PARK, N.J., April 22, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“
HUTCHMED
”) (Nasdaq/AIM:HCM; HKEX:13) today announced the completion of enrollment in the registration phase of its Phase II trial of savolitinib for gastric cancer patients with
MET
amplification.
This clinical trial is a single-arm, multi-center, open-label, Phase II registration study that evaluates the efficacy, safety, and tolerability of savolitinib in treating gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with
MET
amplification. The 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 enrolled in the study can be found at clinicaltrials.gov using identifier
NCT04923932
.
During the American Association for Cancer Research
Annual Meeting, interim results showed a 45% ORR confirmed by the IRC and a 50% ORR among patients with high
MET
gene copy number. The duration of response (DOR) was 85.7% over a median follow-up time of 5.5 months. Common grade 3 or higher treatment-related adverse events (“TRAE”) (≥ 5%) included decreased platelet count, hypersensitivity, anemia, neutropenia, and abnormal liver function. One patient stopped treatment due to grade 4 liver function abnormality (TRAE), but there were no deaths associated with TRAE.
The National Medical Products Administration (“NMPA”) in China has designated savolitinib as a Breakthrough Therapy for locally advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with
MET
amplification who have failed at least two lines of standard therapies. Should the results remain positive, HUTCHMED plans to pursue marketing authorization of savolitinib for gastric cancer in China by late 2025.
About Gastric Cancer with
MET
Amplification
Gastric cancer driven by MET has a very poor prognosis, affecting approximately 4-6% of gastric cancer patients. The annual incidence of MET amplification gastric cancer is estimated at about 18,000 cases in China.
AstraZeneca and HUTCHMED’s Savolitinib Trials Show Promise in Cancer Treatment
A registration trial for savolitinib follows several Phase II studies in Asia, including the VIKTORY study, which focused on MET-driven gastric cancer patients. The VIKTORY study reported a 50% overall response rate (ORR) in patients with tumors harboring MET amplification who received savolitinib as monotherapy.
3
About Savolitinib
Savolitinib is a potent oral MET tyrosine kinase inhibitor (TKI) being co-developed by AstraZeneca and HUTCHMED, with AstraZeneca responsible for its commercialization. The MET receptor tyrosine kinase plays a critical role in normal cell growth. Savolitinib inhibits abnormal activation of the MET pathway due to mutations, gene amplification, or protein overexpression.
Currently approved in China, savolitinib is marketed as ORPATHYS® and is used for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have a MET exon 14 skipping alteration. This marks it as the first selective MET inhibitor approved in China, and it has been listed in the National Reimbursement Drug List of China (NRDL) since March 2023.
Savolitinib is also under clinical investigation for various tumor types, including lung, kidney, and gastric cancers, both as a standalone treatment and in combination with other therapies.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is a commercially active biopharmaceutical firm focused on innovative cancer therapies and immunotherapies. Since its founding, HUTCHMED has prioritized the transition of drug candidates from discovery to patient availability worldwide, with its first three drugs currently marketed in China, including one that is also approved in global markets such as the US, Europe, and Japan. For additional information, visit:
www.hutch-med.com
or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements as defined under the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These statements reflect HUTCHMED’s current expectations regarding future events, including savolitinib’s therapeutic potential and its subsequent clinical development. Risks associated with these forward-looking statements include uncertainties in enrollment rates, regulatory changes, unexpected adverse events, and achieving study endpoints. Investors should be cautious in relying on these forward-looking statements, which are current only as of today. For a thorough discussion on risks, please refer to HUTCHMED’s SEC filings and those with the Stock Exchange of Hong Kong Limited and AIM. HUTCHMED is not obligated to update this information due to new data or future events.
Medical Information
This press release includes information about products that may not yet be available in all markets or may be marketed under different names for various uses and formulations. It should not be seen as a promotion or solicitation for any prescription drugs, including those under development.
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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.
NatCommun.2021;12(4074).
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