AstraZeneca's Tagrisso and Orpathys combo meets Phase III goals
AstraZeneca (NASDAQ: AZN) reported positive high-level results from the SAFFRON Phase III trial, in which the combination of Tagrisso (osimertinib) and Orpathys (savolitinib) demonstrated statistically significant improvements in both progression-free survival and overall survival compared with doublet platinum-based chemotherapy.
The trial enrolled patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer whose tumors showed high levels of MET overexpression or amplification and who had progressed on prior Tagrisso treatment.
According to the press release, the safety profile for the combination was consistent with the known profiles of each medicine, with no new safety findings identified. AstraZeneca said the data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
The Tagrisso and Orpathys combination is already approved in China for patients with locally advanced or metastatic EGFRm non-small cell lung cancer with MET amplification following disease progression on EGFR-tyrosine kinase inhibitor therapy, based on results from the earlier SACHI Phase III trial.
Orpathys is being jointly developed by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca.
