Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 387

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 387
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 savolitinib 400mg or 600mg OD in combination with Tagrisso 80mg OD, compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the standard of care treatment option in this setting. The primary endpoint of the study is PFS as assessed by investigators. In December 2024, the NMPA granted Breakthrough Therapy designation to this combination therapy. In a planned interim analysis, the IDMC considered that the study had met the pre-defined primary endpoint of PFS and enrollment into the study had concluded, leading to an acceptance of NDA with priority review status.
1L EGFRm MET amplification/overexpression NSCLC
About 20% to 30% of EGFRm NSCLC patients experienced unsatisfactory responses to EGFR-TKIs monotherapy. Co-existing de novo MET amplification and/or overexpression was associated with a shorter time to progression. There are large unmet clinical needs for NSCLC patients with both EGFR mutation and MET overexpression. Savolitinib, in combination with Tagrisso, as a first-line treatment, may improve efficacy and overcome MET-driven primary resistance.
SANOVO: Phase III study of savolitinib with Targrisso in 1L EGFRm NSCLC with MET overexpression (NCT05009836)
SANOVO is a China Phase III randomized, double-blind, active-controlled study savolitinib in combination with Tagrisso in 1L EGFRm NSCLC patients with MET overexpression. Patients with untreated unresectable or metastatic NSCLC carrying EGFR mutation (exon 19 deletion or L858R) and MET overexpression (IHC 2+ or 3+) are randomized into two groups: savolitinib 600mg or 400mg OD plus Tagrisso 80mg OD or placebo plus Tagrisso 80mg OD. Primary endpoint is PFS assessed by investigators. First patient was dosed in September 2021. We target recruitment of 320 patients.
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FLOWERS: Phase II study of savolitinib with Targrisso in 1L EGFRm NSCLC with MET amp/overexpression (NCT05163249)
FLOWERS is a China Phase II randomized, investigator-initiated, prospective, multicenter study of savolitinib in combination with Tagrisso, versus Targrisso alone,