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Hutchmed (China) Limited has announced positive high-level results from the SANOVO China phase III trial in treatment-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours harbour epidermal growth factor receptor (EGFR) mutation and MET overexpression.
Orpathys (savolitinib) plus Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) versus Tagrisso alone in both the high MET and intention-to-treat (ITT) patient populations.
In both patient populations, the combination also demonstrated a very encouraging clinical benefit in overall survival (OS), a secondary endpoint of the trial. The trial will continue to follow-up on these results. These data will be presented at a forthcoming medical meeting.
Findings build on the established success of the global SAFFRON and China SACHI trials, extending the clinical value of the all-oral combination into the first-line setting.
Professor Yi-Long Wu of the Guangdong Provincial People's Hospital, and the leading Principal Investigator of the SANOVO trial, said: “Co-occurring MET overexpression in treatment-naïve EGFR-mutated NSCLC often compromises the long-term durability of EGFR-TKI monotherapy. 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 whose tumours have MET overexpression. By combining Orpathys with Tagrisso, we have observed a clear clinical benefit that could reshape primary treatment strategy for this distinct patient population.”
Dr Weiguo Su, chief executive officer and chief scientific officer of Hutchmed, said: “We are thrilled by the positive results from SANOVO, which validate our strategy of addressing MET-driven disease across multiple stages of lung cancer. Building on the strong foundations of our Phase III SAFFRON global study and SACHI study in China in pre-treated patients, SANOVO data further validate the therapeutic strength and versatility of the Orpathys and Tagrisso combination in first-line patients. We are deeply grateful to all patients and investigators who participated in the trial, and we look forward to sharing the data with regulatory authorities to bring this innovative all-oral combination to the first-line setting in China.”
Dr Jing He, head of R&D China, AstraZeneca, said: “These positive data underscore the pivotal role of Orpathys in intercepting MET-driven resistance early in the treatment journey. By combining the targeted precision of Orpathys with backbone Tagrisso, SANOVO demonstrates a meaningful clinical advancement for treatment-naïve patients with MET overexpression and EGFR mutation. Together with Hutchmed, we are excited to advance Orpathys in China as a transformative, biomarker-directed addition to frontline lung cancer care.”
The safety profile for Orpathys plus Tagrisso was consistent with the known profiles of each medicine, and there were no new safety findings.
Orpathys plus Tagrisso is approved in China for patients with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer with MET amplification after disease progression on EGFR-tyrosine kinase inhibitor therapy based on the SACHI phase III trial. The combination also reported positive high-level results in the SAFFRON global phase III trial in EGFRm non-small cell lung cancer with MET overexpression or amplification after disease progression on Tagrisso in demonstrating a statistically significant and clinically meaningful improvement in both PFS and overall survival.
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