Hutchmed said combining Orpathys with Tagrisso reduced the risk of disease progression or death by 44% compared with Tagrisso alone in a Phase 3 trial involving previously untreated lung cancer patients in China.
The SANOVO study enrolled 326 patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR mutations and MET overexpression. Patients were randomly assigned to receive Tagrisso with either Orpathys or a placebo.
Median progression-free survival, the trial’s primary endpoint, was 24.9 months with the combination versus 13.8 months with Tagrisso alone. The difference was statistically significant, with a hazard ratio of 0.56 and a p-value below 0.0001.
Among patients with high MET overexpression, the combination reduced the risk of progression or death by 55%. Median progression-free survival in that subgroup was 24.8 months versus 11.1 months.
Median overall survival, a secondary endpoint, was 44.5 months with the combination and 34.9 months with Tagrisso alone. An estimated 67.4% of combination recipients were alive after three years, compared with 47.4% in the comparator group.
Hutchmed reported no new safety concerns. Adverse events led 14.8% of combination recipients to discontinue treatment. Fatal adverse events, excluding disease progression, occurred in 4.3% of combination recipients and 4.8% of comparator patients.
The results were presented at the European Society for Medical Oncology Congress in Madrid.
Hutchmed plans to seek Chinese approval for the first-line use. The combination is already approved in China for certain patients whose cancer progressed after EGFR-targeted therapy. Orpathys, or savolitinib, is jointly developed by Hutchmed and AstraZeneca and commercialized by AstraZeneca.
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