HUTCHMED has reported positive high‑level results from the Saffron phase 3 trial evaluating Orpathys (savolitinib) plus Tagrisso (osimertinib) in patients with EGFR‑mutated non‑small cell lung cancer who had progressed on prior Tagrisso treatment.
The company said the combination delivered statistically significant and clinically meaningful improvements in progression‑free survival and overall survival compared with platinum‑based chemotherapy.
Patients enrolled in the study had tumours with high levels of MET overexpression or amplification, a common resistance mechanism to third‑generation EGFR‑TKIs. HUTCHMED noted that MET‑driven resistance is associated with poor prognosis and represents a major unmet need in later‑line treatment settings.
Professor Shun Lu, Director of Shanghai Lung Cancer Center and principal investigator, said: “These exciting results from SAFFRON represent a critical advance for patients with EGFR-mutated non-small cell lung cancer experiencing MET-driven resistance after osimertinib, a population with poor outcomes and no biomarker-directed treatment options available that are oral and well-tolerated.”
He added: “MET is one of the most common drivers of progression on targeted therapy in this setting, and these data underscore the potential impact of this novel osimertinib plus savolitinib combination and the urgency of MET testing to inform treatment decisions.”
Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, explained: “Overcoming MET-driven resistance after EGFR TKI therapy has been a long-standing challenge in clinical practice. The SAFFRON global study further reinforces the robust efficacy previously demonstrated in the SACHI phase 3 trial that supported approval in China, with the results providing clear evidence to support global registrations of the TAGRISSO and ORPATHYS combination.”
He added: “Together with AstraZeneca, we look forward to potentially bringing this landmark treatment to patients around the world.”
Dr Susan Galbraith, Executive Vice President, Oncology Hematology R&D at AstraZeneca, said: “These data demonstrate the clear benefit of adding ORPATHYS to backbone therapy TAGRISSO to address MET overexpression or amplification while maintaining EGFR suppression.”
She added: “By combining ORPATHYS and TAGRISSO, we aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe.”
HUTCHMED said the safety profile of the combination was consistent with known data for each medicine, with no new safety findings reported.
