HUTCHMED's Phase III SANOVO trial in China showed ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) delivered a statistically significant improvement in progression-free survival versus TAGRISSO alone in treatment-naïve patients with EGFR-mutated, MET-overexpressing non-small cell lung cancer. The combination also showed encouraging overall survival trends with a safety profile consistent with existing data.
HUTCHMED's Phase III SANOVO trial showed ORPATHYS plus TAGRISSO improved progression-free survival in 326 treatment-naïve patients with EGFR-mutated, MET-overexpressing lung cancer.
"The positive findings from SANOVO demonstrate that addressing both pathways upfront with an all-oral, biomarker-directed regimen offers a powerful new approach for these patients," Professor Yi-Long Wu of Guangdong Provincial People's Hospital and the trial's leading principal investigator, said.
The combination met its primary endpoint of investigator-assessed PFS in both the high MET and intention-to-treat populations, with the trial continuing follow-up on overall survival, a secondary endpoint. Patients were randomized 1:1 to receive TAGRISSO 80 mg once daily plus either ORPATHYS at 300/200 mg twice daily (weight-based) or placebo. Safety was consistent with the known profiles of each medicine, with no new findings.
The results extend the clinical value of the all-oral combination into the first-line setting, building on the SAFFRON global and SACHI China trials in pre-treated patients. ORPATHYS plus TAGRISSO is already approved in China for EGFR-mutated NSCLC with MET amplification after progression on EGFR-TKI therapy. HUTCHMED plans to share the data with regulatory authorities to bring the combination to first-line use in China.
"We are thrilled by the positive results from SANOVO, which validate our strategy of addressing MET-driven disease across multiple stages of lung cancer," Dr. Weiguo Su, chief executive officer and chief scientific officer of HUTCHMED, said.
The SANOVO data follow the SAFFRON global Phase III trial, which in August 2026 reported statistically significant and clinically meaningful improvements in both PFS and overall survival for the combination in EGFR-mutated NSCLC with MET overexpression or amplification after progression on TAGRISSO. ORPATHYS is jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.
ORPATHYS (savolitinib) is an oral, potent and highly selective MET tyrosine kinase inhibitor approved in China for MET exon 14 skipping NSCLC, MET-amplified gastric cancer, and in combination with TAGRISSO for MET-amplified EGFR-mutated NSCLC post-TKI. The combination also received temporary authorization in Switzerland based on the SAVANNAH Phase II trial.
EGFR-mutated NSCLC accounts for 10-15 percent of cases in the US and Europe and 30-40 percent in Asia. MET overexpression or amplification can drive tumor growth and metastatic progression, and co-occurring MET overexpression in treatment-naïve EGFR-mutated NSCLC often compromises the durability of EGFR-TKI monotherapy. Lung cancer is the leading cause of cancer death globally, accounting for nearly one in four cancer deaths.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) shares carry a Hold rating with a HK$21.30 price target, according to TipRanks data. The stock is down 3.83 percent year-to-date with a market capitalization of HK$17.3 billion.
The data will be presented at a forthcoming medical meeting. HUTCHMED intends to engage regulatory authorities in China to expand the combination's use to the first-line setting, which could open a larger patient market given the high prevalence of EGFR mutations among Asian lung cancer patients.
This article is for informational purposes only and does not constitute investment advice.
