Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 128

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 128
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 its drug for the treatment of T790M+ EGFRm+, TKI-resistant NSCLC. A drug with this type of activity is known as a third-generation EGFR inhibitor. In 2018, Tagrisso’ s label was expanded to include 1L metastatic EGFRm NSCLC. In December 2020, Tagrisso’ s label was further expanded to include adjuvant therapy after tumor resection in EGFRm NSCLC. In February 2024, Tagrisso was approved in combination with chemotherapy for 1L EGFRm NSCLC. In September 2024, it was further approved for local advanced unresectable (stage III) EGFRm NSCLC which has not progressed during or following chemoradiation. We and AstraZeneca are studying savolitinib in combination with Tagrisso in both 1L and 2/3L settings which have developed a resistance to TKI (primarily Tagrisso).

2L EGFRm MET amplification/overexpression NSCLC

SAVANNAH: Phase II study of savolitinib with Tagrisso in 2/3L EGFRm NSCLC with MET amp/overexpression (NCT03778229)

SAVANNAH is a global Phase II single-arm study of savolitinib in combination with Tagrisso in 2/3L EGFRm NSCLC with MET amplification and/or overexpression upon disease progression following Tagrisso. The definition of MET overexpression was IHC 3+ in≥50% of tumor cell (IHC50+) while MET amplification referred to FISH MET copy number≥5 or MET:CEP7 ratio≥2 (FISH5+). High cut-off levels for MET overexpression was defined as IHC 3+ in≥90% (IHC90+) and MET amplification being copy number≥10 (FISH10+). In addition to continuing Tagrisso 80mg OD, patients received savolitinib 300mg OD, 300mg BID or 600mg OD.

Table of Contents

Novel biomarker and patient enrichment strategy driven by SAVANNAH

Results of SAVANNAH at WCLC 2022: efficacy in patients with MET-high vs MET-low amp/overexpression

Results were presented at WCLC 2022 for 193 efficacy eval