Enrollment Complete for HUTCHMED's Phase II Study of Savolitinib
HUTCHMED (China) Limited has marked a significant achievement in its ongoing commitment to advancing cancer treatment by completing patient enrollment in its Phase II registration study of Savolitinib. This clinical trial focuses on gastric cancer patients exhibiting MET amplification, an important biomarker influencing treatment response.
Details of the Clinical Trial
This Phase II trial is designed as a single-arm, multi-center, open-label study that examines the safety, efficacy, and tolerability of Savolitinib for patients diagnosed with gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma. The primary goal of this study is to assess the overall response rate (ORR), as determined by an Independent Review Committee, using the RECIST 1.1 criteria. The secondary endpoints include evaluating progression-free survival (PFS) and the occurrence of various adverse events (AEs).
Study Participation and Results
In total, 64 patients have been enrolled in the trial, reflecting a robust engagement from the targeted population. Initial results shared during a recent annual meeting showcased promising data, revealing a 45% ORR when evaluated by the IRC. More specifically, a notable 50% ORR was observed in patients with high MET gene copy numbers. The duration of response (DOR) was impressive, with 85.7% maintaining a response for at least four months and a median follow-up period of 5.5 months.
Savolitinib's Safety Profile
The safety profile of Savolitinib appears manageable, with the most frequently reported grade 3 or higher treatment-related adverse events (TRAE) including decreased platelet counts, hypersensitivity reactions, anemia, neutropenia, and abnormalities in liver function. Importantly, only one participant withdrew from the study due to a serious adverse event related to liver function, emphasizing the drug's relative safety.
Regulatory Progress for Savolitinib
In recognition of its potential, China's National Medical Products Administration (NMPA) has granted Savolitinib Breakthrough Therapy Designation for patients with advanced gastric cancer or GEJ adenocarcinoma. This designation could expedite the regulatory review process, paving the way for potential marketing authorization applications in late 2025, subject to positive study results.
Understanding MET Amplification in Gastric Cancer
MET amplification represents a significant concern in gastric cancers, with current estimates suggesting it affects approximately 4-6% of patients. In China alone, this translates to around 18,000 new cases diagnosed annually. The ongoing registration trial is part of a broader investigation into MET-driven gastric cancer, having previously built on data gathered from multiple Phase II studies, including the notable VIKTORY trial, which confirmed a 50% ORR for patients undergoing treatment with Savolitinib.
Insights on Savolitinib
Savolitinib is a potent oral MET tyrosine kinase inhibitor developed in partnership with AstraZeneca. It selectively targets the MET receptor, which plays a critical role in various cellular processes. By inhibiting abnormal MET receptor activation caused by gene amplification and mutations, Savolitinib provides a targeted approach to treating MET-driven malignancies.
In addition to its current use in gastric cancer, Savolitinib is approved in China for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations, marketed under the brand name ORPATHYS. The drug's inclusion in the National Reimbursement Drug List of China as of March 2023 is a testament to its increasing clinical value.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) stands at the forefront of cancer and immunological disease treatment innovation. With a strong pipeline of targeted therapies and immunotherapies, the company is dedicated to facilitating the transition of groundbreaking drug candidates from initial development phase to market, enhancing patient care worldwide. Current efforts encompass not just Savolitinib, but also various therapies for multiple tumor types.
Contact Information
For investor queries, you may reach out at +852 2121 8200 or contact via email at ir@hutch-med.com.
For media inquiries, FTI Consulting can be contacted at +44 20 3727 1030 or via email at HUTCHMED@fticonsulting.com.
Frequently Asked Questions
What is the Phase II trial about?
The trial investigates Savolitinib's efficacy, safety, and tolerability in patients with gastric cancer displaying MET amplification.
How many patients were enrolled in the study?
A total of 64 patients have participated in the clinical trial.
What were the preliminary results of the trial?
The trial reported a 45% overall response rate, with a higher 50% response in patients with high MET gene copy numbers.
What is the significance of NMPA's Breakthrough Therapy Designation?
This designation may facilitate expedited review and approval for Savolitinib as a treatment option for advanced gastric cancer patients.
Who is developing Savolitinib?
Savolitinib is being developed by HUTCHMED and AstraZeneca, designed to inhibit abnormal MET receptor activity in targeted cancers.
