AstraZeneca's Tagrisso combo shows Phase III benefit in lung cancer

AstraZeneca (NASDAQ: AZN) announced positive high-level results from the SANOVO Phase III trial, showing that Tagrisso (osimertinib) combined with Orpathys (savolitinib) produced a statistically significant improvement in progression-free survival (PFS) compared with Tagrisso alone in treatment-naïve patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) and MET overexpression.

The PFS benefit was observed in both the high MET (IHC 3+) and the intention-to-treat (ITT) trial populations (IHC 2+ and IHC 3+). The combination also showed clinical benefit in overall survival (OS), a secondary endpoint, in both patient populations. The trial will continue to follow up on those results.

The safety profile for the combination was consistent with the known profiles of each medicine, with no new safety findings reported. Full data are expected to be presented at a forthcoming medical meeting and shared with regulatory authorities.

Professor Yi-Long Wu of Guangdong Provincial People's Hospital and lead principal investigator said the findings "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."

Orpathys is jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. The combination is currently approved in China for patients with locally advanced or metastatic EGFRm NSCLC with MET amplification after disease progression on EGFR-TKI therapy, based on results from the SACHI Phase III trial. The SAFFRON global Phase III trial, which tested the combination in pre-treated patients with MET overexpression or amplification following Tagrisso, also recently reported positive results in both PFS and OS.

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