Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 134

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 134
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olitinib Phase I and Phase II monotherapy studies) and is a mechanism of resistance against kinase inhibitors in clear cell RCC. Moreover, it is believed that the MET signaling pathway has a complex interplay with the immune system, including correlation with PD-L1 expression, immune suppression through angiogenesis and many other facets of the immune system.

Table of Contents

SAMETA: Phase III study of savolitinib with Imfinzi PD-L1 inhibitor in MET-driven PRCC (NCT05043090)

SAMETA is a global Phase III randomized, open-label, active-controlled three-arm study of savolitinib in combination with Imfinzi in treatment-naïve patients with MET-driven, unresectable and locally advanced or metastatic PRCC. Patients were randomized in 2:1:1 ratio to receive 600 mg of savolitinib OD plus Imfinzi or Imfinzi monotherapy or Sutent monotherapy, an oral multi-kinase inhibitor considered as the standard of care treatment option in PRCC. The primary endpoint of the study is PFS. The first patient was dosed in October 2021. We completed the enrollment of 140 patients in 2024.

Prior to SAMETA, we have conducted multiple global studies of savolitinib in PRCC patients, including the SAVOIR monotherapy and CALYPSO combination therapy trials, that both demonstrated highly encouraging results. The CALYPSO study was a global Phase II open-label investigator-initiated study of savolitinib in combination with Imfinzi in PRCC patients in the U. K. and Spain. 24-month follow-up showed median PFS of 15.7 months and median OS of 27.4 months in MET-driven PRCC patients. These results led to the initiation of a global Phase III SAMETA study in 2021.

Savolitinib - Gastric Cancer

  Treatment        Patient Focus                     Sites      Phase                Status/Plan                                   NCT #        
  Savolitinib      3L GC with MET amplification      China      II Registration      Ongoing Breakthrough Therapy Designation      NCT04923932  
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Phase II study of savolitinib in 3L GC with MET amplification (NCT04923932)

MET-driven GC has a very poor prognosis. We are carrying out a China Phase II two-stage,