HUTCHMED Phase III trial cuts progression risk 44%

• HUTCHMED reported Phase III SANOVO results showing ORPATHYS plus TAGRISSO reduced the relative risk of disease progression or death by 44% compared with TAGRISSO alone.
• Median progression-free survival reached 24.9 months versus 13.8 months overall, while median overall survival was 44.5 months versus 34.9 months.
• HUTCHMED plans to submit a supplemental New Drug Application in China seeking approval for first-line treatment of EGFR-mutated lung cancer with MET overexpression.

HUTCHMED (NASDAQ:HCM) reported Phase III SANOVO results showing that ORPATHYS plus TAGRISSO reduced the risk of disease progression or death by 44% in previously untreated EGFR-mutated lung cancer patients.

The China-based trial enrolled 326 patients with locally advanced or metastatic non-small cell lung cancer and MET overexpression, with median progression-free survival reaching 24.9 months for the combination versus 13.8 months for TAGRISSO alone.

Professor Yi-Long Wu, the trial's lead investigator, previously said the findings demonstrated the potential of targeting both EGFR and MET pathways from the beginning of treatment.

Among patients with high MET expression, median progression-free survival reached 24.8 months versus 11.1 months, representing a 55% relative reduction in progression or death risk.

HUTCHMED plans to submit a supplemental New Drug Application in China for first-line use of ORPATHYS plus TAGRISSO, subject to regulatory review.

Median overall survival reached 44.5 months with the combination compared with 34.9 months for TAGRISSO alone, while adverse events led to treatment discontinuation in 14.8% of combination-treated patients.

Fatal adverse events excluding disease progression occurred in 4.3% of combination recipients versus 4.8% of patients receiving TAGRISSO alone, with the company reporting no new safety concerns.

The SANOVO results were scheduled for presentation at ESMO 2026 on October 26, following HUTCHMED's initial positive Phase III announcement in August.