First global Phase III trial to show significant progression-free and overall survival benefits in this setting

SAFFRON trial results reinforce TAGRISSO as the backbone therapy across EGFRm lung cancer

Positive high-level results from the SAFFRON Phase III trial showed TAGRISSO® (osimertinib) plus savolitinib demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) versus doublet platinum-based chemotherapy in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Patients in the trial had tumors with high levels of MET overexpression or amplification and had progressed on prior treatment with TAGRISSO.

Third-generation EGFR-tyrosine kinase inhibitors (TKIs) have significantly improved outcomes for patients with EGFRm NSCLC. However, one in three patients’ tumors will develop MET overexpression or amplification, one of the most common mechanisms of resistance on third-generation EGFR-TKIs.1-2 MET-driven resistance is associated with poor prognosis, and there is a significant unmet need for effective and well-tolerated treatment options in later-line settings.

The safety profile for TAGRISSO plus savolitinib was consistent with the known profiles of each medicine, and there were no new safety findings. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

TAGRISSO plus savolitinib is approved in China for patients with locally advanced or metastatic EGFRm NSCLC with MET amplification after disease progression on EGFR-TKI therapy based on the SACHI Phase III trial.

Savolitinib is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.