Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 129

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 129
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uable patients on savolitinib 300mg OD plus Tagrisso 80mg OD with cut-off date of August 27, 2021. The prevalence of the high cut-off levels of MET amplification/overexpression was 34% of patients centrally tested for enrollment in this study. Results showed a trend toward improved response rates with increasing level of MET aberration with ORR of 32%, DoR of 8.3 months and PFS of 5.3 months for all patients. Among the 108 patients who met high cut-off levels, ORR was 49%; DoR was 9.3 months; and PFS was 7.1 months. Among the 87 patients who met high cut-off levels and did not receive prior chemotherapy, ORR was 52%; DoR was 9.6 months; and PFS was 7.2 months. The safety profile of savolitinib plus Tagrisso was consistent with that of the combination and of each treatment alone. Grade≥3 adverse effects occurred in 45% of patients, with pulmonary embolism at 5%, dyspnoea at 4% and decreased neutropil count at 4%.

In 2022, a registrational cohort was expanded focusing on patients who met the high cut-off levels and treated with savolitinib 300 mg BID (instead of OD in WCLC 2022 reported cohort) and Tagrisso 80 mg OD. Another small cohort was on savolitinib 300mg BID plus placebo. In October 2024, positive high-level results from the registational cohort showed the combination demonstrated a high, clinically meaningful and durable ORR. Results of this registrational cohort of 101 patients will be presented at ELCC 2025 in March 2025.

SAFFRON: Phase III study of savolitinib with Tagrisso in 2/3L EGFRm NSCLC with MET amp/overexpression (NCT05261399)

SAFFRON is a global Phase III randomized, open-label, active-controlled study of savolitinib with Tagrisso in 2/3L EGFRm locally advanced or metastatic NSCLC patients with MET amplification and/or overexpression and progressed on 1L or 2L treatment with Tagrisso as the most recent therapy, with no prior chemotherapy in the metastatic setting allowed. Findings based on SAVANNAH and the