HUTCHMED reports Phase III SANOVO results showing an 11.1-month PFS improvement with savolitinib plus osimertinib in EGFR-mutated, MET-overexpressing advanced NSCLC.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
HUTCHMED (China) reported positive Phase III SANOVO results showing that savolitinib (ORPATHYS) plus osimertinib (TAGRISSO) significantly improved progression-free survival (PFS) compared with osimertinib alone in previously untreated patients with EGFR-mutated, MET-overexpressing locally advanced or metastatic non-small cell lung cancer (NSCLC). The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2026 on October 26 as abstract LBA69.
SANOVO Trial Design and Patient Population
SANOVO (NCT05009836) was a randomized, blinded, controlled Phase III trial conducted in China. It enrolled 326 treatment-naïve patients whose tumours harboured EGFR exon 19 deletions or L858R mutations alongside MET overexpression. Patients were randomized 1:1 to receive osimertinib 80 mg once daily with either savolitinib or placebo. Savolitinib was administered at 200 or 300 mg twice daily according to body weight.
The primary endpoint was investigator-assessed PFS. Secondary endpoints included overall survival (OS), independently assessed PFS, objective response rate, duration of response and safety. The PFS data cut-off was July 31, 2026.
Combination Therapy Extended Median PFS by 11.1 Months
In the intention-to-treat (ITT) population, comprising patients with MET immunohistochemistry (IHC) 2+ or IHC 3+ expression, median PFS was 24.9 months with savolitinib plus osimertinib, compared with 13.8 months with placebo plus osimertinib.
The combination reduced the hazard of disease progression or death by 44% (HR 0.56; 95% CI, 0.43–0.74; p<0.0001). Progression or death occurred in 101 of 162 patients (62.3%) receiving the combination, compared with 124 of 164 patients (75.6%) in the control group.
The benefit was also observed in the high-MET subgroup, defined as IHC 3+ expression in more than 90% of tumour cells. Median PFS was 24.8 months with the combination versus 11.1 months with osimertinib alone, an improvement of 13.7 months. The hazard of progression or death was reduced by 55% (HR, 0.45; 95% CI, 0.31–0.66; p<0.0001). This subgroup included 98 patients in each arm.
The results establish a statistically significant PFS improvement in the overall study population. Although the high-MET subgroup showed a larger observed treatment effect, this difference alone does not establish MET expression as a validated predictor of differential treatment benefit.
Overall Survival Also Favoured the Combination
OS, a secondary endpoint, also favoured savolitinib plus osimertinib. Median OS was 44.5 months with the combination and 34.9 months with placebo plus osimertinib, a difference of 9.6 months. The OS hazard ratio was 0.48 (95% CI, 0.33–0.68).
At three years, estimated survival was 67.4% in the combination group and 47.4% in the control group. Deaths had occurred in 49 patients (30.2%) receiving the combination and 83 patients (50.6%) receiving the control regimen.
The combination group’s median OS confidence interval extended from 41.3 months to not estimable, indicating that the upper confidence limit could not be calculated at the reported analysis. Although the OS results support a favourable survival signal, the company announcement did not provide an OS p-value in its summary table. The findings should therefore be interpreted in the context of the endpoint’s statistical analysis and maturity.
Safety and Treatment Tolerability
HUTCHMED described the combination’s safety profile as manageable and consistent with the known profiles of both medicines, with no new safety concerns identified. Adverse events led to treatment discontinuation in 14.8% of patients receiving savolitinib plus osimertinib. Most adverse events were managed through dose adjustments.
Fatal adverse-event rates, excluding events associated with disease progression, were 4.3% with the combination and 4.8% with placebo plus osimertinib. A fuller assessment of tolerability would require the detailed adverse-event profile, including event severity and serious adverse events across both treatment arms.
Clinical Significance and Regulatory Outlook
Osimertinib inhibits EGFR, while savolitinib targets MET. MET overexpression or amplification can contribute to tumour signalling and may be associated with resistance to EGFR-targeted treatment. Combining the agents is intended to inhibit both pathways from the beginning of treatment. However, MET overexpression and MET amplification are distinct biomarker findings and should not be treated as interchangeable.
SANOVO complements HUTCHMED’s broader savolitinib–osimertinib programme. The SACHI trial supported approval of the combination in China for EGFR-mutated non-squamous NSCLC with MET amplification after progression on EGFR-TKI therapy. The global SAFFRON trial addresses a later-line setting following progression on osimertinib, whereas SANOVO evaluated previously untreated patients selected for MET overexpression.
HUTCHMED plans to submit a supplementary New Drug Application in China for the first-line indication. The SANOVO findings provide Phase III evidence supporting further regulatory evaluation, but approval for this specific use remains subject to a regulatory decision.
Reference
HUTCHMED Highlights SANOVO Phase III Data for ORPATHYS® plus TAGRISSO® in First-Line EGFR-Mutated Lung Cancer Presented at ESMO Congress 2026, HUTCHMED, 26 October 2026
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC (SANOVO), ClinicalTrials.gov ID NCT05009836
About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.