Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 386

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 386
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 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 TATTON studies supported the initiation of SAFFRON. Patients are prospectively selected for the higher level of MET aberration of FISH10+ and/or IHC90+. The SAFFRON study will evaluate the efficacy and safety of savolitinib in combination with Tagrisso compared to pemetrexed plus platinum doublet-chemotherapy, the current standard-of-care treatment in this setting. The primary endpoint of the study is PFS. Our partner AstraZeneca plans to recruit about 320 patients.
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SACHI: Phase III study of savolitinib with Targrisso in 2L EGFRm NSCLC with MET amplification (NCT05015608)
SACHI is a China Phase III open-label, randomized, controlled study on patients with locally advanced or metastatic EGFRm NSCLC with MET amplification after progression on first-, second- or third-generation EGFR inhibitor therapy. The study will evaluate