Zhitong Finance App News, Hehuang Pharmaceutical (00013) announced the positive results of the SANOVO China Phase III study. In patients with initially treated locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (“EGFR”) mutations and MET overexpression, the combination therapy of Warisha® (savolitinib) and Teresa® (osimertinib) compared with Teresa® alone showed a statistically significant and highly clinically significant improvement in progression-free survival (“PFS”) at the primary endpoint. The combination therapy also showed very encouraging overall survival (“OS”) clinical benefits (one of the study's secondary endpoints).
The above results were presented in the Selected Oral Report (Proffered Paper) session of the 2026 European Society of Medical Oncology (“ESMO”) Annual Meeting in Madrid, Spain (abstract number #LBA69).
PFS benefits were observed in people with high levels of MET (IHC 3+) and intentional treatment (“ITT”) groups (IHC 2+, IHC 3+). Among ITT people, the combination therapy with Warisa® and Teresa® reduced the risk of disease progression or death by 44% (based on PFS risk ratio [“HR”] 0.56; 95% confidence interval [“CI”] 0.43—0.74; p<0.0001) compared with Teresa® alone. The median PFS of this combination was over 2 years (24.9 months), while Teresa® alone was approximately 1 year (13.8 months).
In people with high levels of MET, combination therapy with Warisha® and Teresa® reduced the risk of disease progression or death by 55% (PFS HR 0.45; 95% CI 0.31-0.66; p<0.0001) compared with Teresa® alone. The Warisha® and Teresa® combination therapy group increased median PFS by 13.7 months (24.8 months versus 11.1 months).
In terms of secondary endpoint OS, the combination treatment of Warisa® and Teresa® showed clinically significant OS improvements (OS HR 0.48; 95% CI 0.33-0.68) compared to Teresa® alone in ITT people. Compared to the control group, the Warisha® and Teresa® combination therapy group extended the median OS by 9.6 months (44.5 months versus 34.9 months). An estimated 67.4% of patients in the combination therapy group were still alive at 3 years, compared to 47.4% in the control group. As follow-up time increased, the OS curve continued to separate, indicating that the benefits of the Warisha-Teresha® and Teresha® combination therapy have further expanded over time. Notably, consistent PFS and OS benefits were observed across all of the pre-set ITT subgroups.
The study's lead researcher, Professor Wu Yilong of Guangdong Provincial People's Hospital, said, “The results of the SANOVO study brought about a breakthrough change in the treatment of first-line EGFR mutant lung cancer. In the past, for patients with MET changes at the same time, it often indicated that patients received EGFR-TKI treatment had poor prognosis, increasing their motivation to test for MET changes during diagnosis and disease progression. The results of this study, which has the potential to reshape clinical practice, showed that adding ositinib to first-line treatment of EGFR mutant lung cancer with MET overexpression extended the median PFS of more than 1 year in people with high levels of MET, and also extended the median PFS of the overall population by 11 months. Coupled with the same encouraging OS clinical benefits, these data further confirm the breakthrough potential of this combination therapy, bringing a fully oral, biomarker oriented treatment plan to patients who find it difficult to benefit from EGFR-TKI alone in the long term due to MET overexpression.”
Mr. Zheng Zefeng, Acting CEO and Chief Financial Officer of Hewang Pharmaceuticals, said, “The SANOVO study, together with SAFFRON and SACHI studies, has jointly constructed a comprehensive continuous treatment pattern for the combination therapy plan of Warisa® and Teresa® from first-line intervention to EGFR-TKI resistance. The SANOVO study confirmed that identifying MET overexpression during diagnosis and using a full oral dual-target combination scheme as early as possible can maintain patients' quality of life while bringing significant clinically significant PFS and OS benefits. SANOVO further validates our core strategy of improving long-term clinical outcomes for patients by advancing precision oncology treatment to the forefront.”
Dr. He Jing, AstraZeneca's global senior vice president and head of global research and development in China, said, “The results of the SANOVO study echo the proven efficacy of SAFFRON and SACHI studies, bringing the combined use of Warisza® and the cornerstone therapy Teresa® to first-line treatment, bringing benefits to patients with EGFR mutation lung cancer accompanied by excessive MET expression. This fully oral, biomarker oriented combination therapy targets both EGFR and MET pathways, improving progression-free survival and overall survival of patients with these diseases. “These results allow us to further advance our strategy to redefine treatment standards for patients with EGFR mutant lung cancer by providing innovative targeted combination therapies.”