HUTCHMED’s Phase III SAFFRON trial found that savolitinib plus osimertinib significantly improved progression-free and overall survival in patients with MET-driven, EGFR-mutated non-small cell lung cancer (NSCLC) following progression on osimertinib.
MET overexpression or amplification can drive resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in patients with EGFR-mutated non-small cell lung cancer (NSCLC), leaving patients with disease progression in need of new treatment options.
HUTCHMED has reported positive topline findings from its SAFFRON trial, which evaluated ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) against doublet platinum-based chemotherapy in patients with EGFR-mutated NSCLC whose disease had progressed following osimertinib treatment.
Presented at the European Society for Medical Oncology (ESMO) Congress 2026 and published simultaneously in The New England Journal of Medicine, the results showed that the combination reduced the risk of disease progression or death by 45 percent compared with chemotherapy (hazard ratio [HR] 0.55; 95% confidence interval [CI]: 0.42-0.72; p<0.001).
Median progression-free survival (PFS) was 7.6 months with the combination, versus 5.4 months with chemotherapy. At 12 months, an estimated 36 percent of patients receiving the combination remained progression-free, compared with 10 percent in the chemotherapy group.
The treatment also demonstrated an overall survival (OS) benefit, reducing the risk of death by 32 percent (HR 0.68; 95% CI 0.50-0.91; p=0.010). Median OS reached 17.8 months, compared with 12.9 months with chemotherapy, an extension of 4.9 months.
Savolitinib plus osimertinib significantly extended median overall survival by nearly five months in this later-line setting, establishing a new clinical benchmark and reinforcing the critical need for MET testing to guide patient care.”
- Professor Shun Lu, Shanghai Chest Hospital
Professor Shun Lu, global leading principal investigator of the trial, said: “Savolitinib plus osimertinib significantly extended median overall survival by nearly five months in this later-line setting, establishing a new clinical benchmark and reinforcing the critical need for MET testing to guide patient care.”
Grade 3 or higher treatment-emergent adverse events occurred in 64 percent of patients receiving the combination and 63 percent of those receiving chemotherapy. HUTCHMED said the safety profile was manageable, with no new safety concerns identified.
Regulatory submissions are progressing in the US, Europe and Japan, potentially expanding treatment options for patients with MET-driven resistance.
No comments yet