Core Viewpoint - HUTCHMED has completed enrollment for the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification, indicating progress in developing targeted therapies for this patient population [1][4]. Group 1: Clinical Trial Details - The Phase II trial is a single-arm, multi-center, open-label study aimed at evaluating the efficacy, safety, and tolerability of savolitinib in treating gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification, with a total of 64 patients enrolled [2]. - The primary endpoint is the objective response rate (ORR) evaluated by the Independent Review Committee (IRC), while secondary endpoints include progression-free survival (PFS) and the incidence of various adverse events [2]. Group 2: Interim Results - Interim results from the study reported a 45% ORR confirmed by IRC and a 50% ORR in patients with high MET gene copy number, with an 85.7% duration of response (DOR) rate over a median follow-up of 5.5 months [3]. - The most common grade 3 or higher treatment-related adverse events included decreased platelet count, hypersensitivity, anemia, neutropenia, and hepatic function abnormalities, with only one patient discontinuing treatment due to a grade 4 liver function abnormality [3]. Group 3: Regulatory Designation and Market Potential - The National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy Designation to savolitinib for treating locally advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with MET amplification who have failed at least two lines of standard therapies [4]. - If the trial results are positive, HUTCHMED may apply for marketing authorization for savolitinib in China by late 2025, highlighting the potential market opportunity for this treatment [4][5]. Group 4: Background on Gastric Cancer and Savolitinib - MET-driven gastric cancer has a poor prognosis, with MET amplification accounting for approximately 4-6% of gastric cancer patients, translating to an estimated annual incidence of about 18,000 cases in China [5]. - Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, currently approved in China for treating non-small cell lung cancer with MET exon 14 skipping alteration [6][7].

Core Viewpoint - HUTCHMED has completed enrollment for the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification, indicating progress in developing targeted therapies for this patient population [1][4]. Group 1: Clinical Trial Details - The Phase II trial is a single-arm, multi-center, open-label study aimed at evaluating the efficacy, safety, and tolerability of savolitinib in treating gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification, with a total of 64 patients enrolled [2]. - The primary endpoint is the objective response rate (ORR) evaluated by the Independent Review Committee (IRC), while secondary endpoints include progression-free survival (PFS) and the incidence of adverse events [2]. Group 2: Interim Results - Interim results from the study reported a 45% ORR confirmed by IRC and a 50% ORR in patients with high MET gene copy number, with an 85.7% duration of response rate over four months and a median follow-up time of 5.5 months [3]. - The most common grade 3 or higher treatment-related adverse events included decreased platelet count, hypersensitivity, anemia, neutropenia, and hepatic function abnormalities, with only one patient discontinuing treatment due to a grade 4 liver function abnormality [3]. Group 3: Regulatory Designation and Market Potential - The National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy Designation to savolitinib for treating locally advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with MET amplification who have failed at least two lines of standard therapies [4]. - If the trial results are positive, HUTCHMED may apply for marketing authorization for savolitinib in China by late 2025, highlighting the potential market opportunity for this treatment [4]. Group 4: Background on Gastric Cancer and MET Amplification - MET-driven gastric cancer has a poor prognosis, with MET amplification accounting for approximately 4-6% of gastric cancer patients, translating to an estimated annual incidence of about 18,000 cases in China [5]. - Previous studies, including the VIKTORY study, have shown a 50% ORR in patients with MET amplification treated with savolitinib monotherapy, supporting the ongoing clinical development of this drug [5]. Group 5: About Savolitinib - Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor developed jointly by AstraZeneca and HUTCHMED, currently approved in China for treating non-small cell lung cancer with MET exon 14 skipping alteration [6][7]. - The drug is also under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, both as a monotherapy and in combination with other treatments [8].

Core Insights - The SAVANNAH Phase II trial demonstrated high and durable response rates for savolitinib combined with TAGRISSO® in patients with MET-high lung cancer, indicating a promising oral treatment strategy for advanced cases [1][2][3] - Long-term survival benefits and safety were observed in the Phase IIIb study of savolitinib for patients with METex14 NSCLC, particularly in treatment-naïve patients [1][7] Group 1: SAVANNAH Phase II Trial Results - The SAVANNAH Phase II trial showed a confirmed objective response rate (ORR) of 56% (95% CI: 45%–67%) and a median duration of response (DoR) of 7.1 months (95% CI: 5.6–9.6) for savolitinib plus TAGRISSO® [3][4] - The median progression-free survival (PFS) was reported as 7.4 months (95% CI: 5.5–7.6) [3] Group 2: Safety Profile - Safety results indicated that Grade 3 or higher adverse events occurred in 57% of patients, with 32% experiencing Grade 3 or higher treatment-related adverse events [4] - No new safety concerns were reported, aligning with the established safety profiles of the medications involved [4] Group 3: Phase IIIb Study Outcomes - In the Phase IIIb study, treatment-naïve patients had a median overall survival (OS) of 28.3 months (95% CI: 17.5–not evaluable), with a 36-month OS rate of 44.7% [7] - Previously treated patients had a median OS of 25.3 months (95% CI: 20.5–30.5), with a 24-month OS rate of 51.7% [7] Group 4: Drug Development and Approval - Savolitinib is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, which received Fast Track Designation from the FDA in 2023 [5][14] - The drug is approved in China under the brand name ORPATHYS® for patients with MET exon 14 skipping alterations [8][15] Group 5: Surufatinib Study Insights - Surufatinib combined with PD-1/PD-L1 antibodies showed durable survival benefits in extensive-stage small cell lung cancer (SCLC) patients, with 12-month and 18-month OS rates of 57.1% for maintenance therapy [9] - The exploratory study involved 21 patients, with a median follow-up duration of 17.1 months for maintenance therapy [9] Group 6: Company Overview - HUTCHMED is a biopharmaceutical company focused on the discovery and commercialization of targeted therapies for cancer and immunological diseases [19] - The company has successfully brought multiple drug candidates to market, with its first three medicines approved in China and one also approved globally [19]