HUTCHMED Ltd (HCM) Form 6-K — Nov 2, 2026
HUTCHMED announced that regulatory filings for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) in MET-driven EGFR-mutated lung cancer have been accepted for review in Europe and Japan, following the US FDA NDA submission in September 2026. The filings are supported by the SAFFRON Phase III trial, which showed the combination reduced risk of progression or death by 45% versus chemotherapy (PFS HR 0.55) and risk of death by 32% (OS HR 0.68), with median OS of 17.8 versus 12.9 months.
Key figures
- Os hazard ratio
- 0.68
- Pfs hazard ratio
- 0.55
- Saffron patients
- 338
- Saffron countries
- 29
- Us fda nda submitted
- September 2026
- Os median comparator months
- 12.9
- Os median combination months
- 17.8
- Pfs median comparator months
- 5.4
- Pfs median combination months
- 7.6
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