Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 385

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 385
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L 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.
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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 evaluable 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