HUTCHMED Reports SANOVO Phase 3 Results in EGFR-Mutated NSCLC

HONG KONG, SHANGHAI AND FLORHAM PARK, N.J. — October 26, 2026

SANOVO Demonstrates Sustained PFS Gains Across MET Groups

SANOVO was a randomized, blinded, controlled Phase 3 trial enrolling 326 treatment-naïve patients in China with locally advanced or metastatic NSCLC harboring activating EGFR mutations, including exon 19 deletions or L858R mutations, alongside MET overexpression. Patients were randomized 1:1 to receive TAGRISSO 80 mg once daily with either ORPATHYS or placebo. ORPATHYS was administered at 300 mg or 200 mg twice daily according to body weight. The primary endpoint was investigator-assessed PFS, with OS among the secondary endpoints. In the ITT population, 101 of 162 patients (62.3%) in the combination group and 124 of 164 patients (75.6%) in the control group had experienced a PFS event at the reported cutoff. Median PFS was 24.9 months with the combination and 13.8 months with TAGRISSO alone, an improvement of 11.1 months. In the high MET expression subgroup, comprising 98 patients in each treatment arm, median PFS was 24.8 months versus 11.1 months, a difference of 13.7 months. The findings indicate that the PFS benefit was observed in both the overall trial population and the subgroup with the highest reported MET expression. The OS analysis also favored the combination. In the ITT population, 49 patients (30.2%) in the combination arm and 83 patients (50.6%) in the control arm had died by the reported analysis. Median OS was 44.5 months with ORPATHYS plus TAGRISSO and 34.9 months with TAGRISSO alone, representing a 9.6-month difference. The OS HR was 0.48 (95% CI, 0.33–0.68). At three years, the estimated survival rate was 67.4% with the combination, compared with 47.4% in the control group. The company reported that PFS and OS benefits were consistent across prespecified ITT subgroups. These findings support investigation of MET overexpression as a biomarker for treatment selection, although clinical decisions require consideration of individual patient characteristics, test results and applicable treatment guidance.

Combination Safety and Tolerability Findings

HUTCHMED reported that the safety profile of ORPATHYS plus TAGRISSO was manageable and consistent with the known safety profiles of the individual medicines, with no new safety concerns identified. Treatment discontinuation due to adverse events occurred in 14.8% of patients receiving the combination. Most adverse events were reported to be manageable with dose adjustments. Fatal adverse events, excluding those attributed to disease progression, were low and balanced between treatment groups, at 4.3% with the combination and 4.8% with TAGRISSO alone. These findings provide information about the tolerability of dual EGFR and MET inhibition in previously untreated patients, though detailed adverse-event categories and severity breakdowns were not included in the supplied summary. The rationale for the combination is based on targeting two signaling pathways involved in tumor growth. TAGRISSO is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), while ORPATHYS is an oral, selective MET TKI. EGFR mutations drive tumor growth in a subset of NSCLC, and MET overexpression or amplification may contribute to tumor progression or resistance to EGFR-targeted treatment. By targeting both pathways from the outset, the combination is intended to address co-occurring MET-related signaling in patients whose tumors demonstrate the relevant biomarker. Unlike chemotherapy-containing regimens, the SANOVO treatment strategy combines two oral targeted medicines. Nevertheless, the results do not establish that the combination is suitable for every patient with EGFR-mutated lung cancer; the trial specifically enrolled patients with MET overexpression. MET testing and appropriate patient selection are therefore central to the approach. The findings were presented at ESMO 2026 as abstract LBA69. The reported PFS data cutoff was July 31, 2026, and the OS results were presented as a secondary endpoint analysis. Continued follow-up and regulatory review will help clarify the durability of the benefit and the treatment’s place in clinical practice.

HUTCHMED and AstraZeneca Advance Biomarker-Driven Treatment

ORPATHYS is jointly developed by HUTCHMED and AstraZeneca, with AstraZeneca responsible for commercialization. The combination of ORPATHYS and TAGRISSO has an established development history in EGFRm NSCLC with MET-related disease. In China, the combination is approved for locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after progression on EGFR-TKI therapy, based on the Phase 3 SACHI trial. It also received temporary authorization in Switzerland for a related population with high MET overexpression or amplification following prior TAGRISSO treatment, based on the Phase 2 SAVANNAH study. Separately, the global Phase 3 SAFFRON trial reported positive results in patients whose EGFRm NSCLC progressed after TAGRISSO and whose tumors had high MET overexpression or amplification. SANOVO extends the investigation into the first-line setting, where treatment is initiated before prior systemic therapy for advanced disease. HUTCHMED plans to use the SANOVO findings to support a supplemental regulatory submission in China. Any expansion of the combination’s approved indications will depend on regulatory assessment and the complete clinical evidence. HUTCHMED is a commercial-stage biopharmaceutical company focused on discovering, developing and commercializing targeted therapies and immunotherapies for cancer and immunological diseases. AstraZeneca develops medicines across multiple therapeutic areas, including targeted treatments for lung cancer. The SANOVO findings add Phase 3 evidence for an upfront biomarker-directed approach in EGFR-mutated NSCLC with MET overexpression. The combination’s future role will depend on regulatory decisions, access to reliable biomarker testing and evaluation of its benefits and risks against available treatment options.

Source:HUTCHMED, ,Press release