Key Takeaways:
Savolitinib (ORPATHYS) plus osimertinib (TAGRISSO) improved progression-free and overall survival versus doublet platinum-based chemotherapy in a 338-patient Phase III trial, HUTCHMED 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," Shun Lu, director of the Shanghai Lung Cancer Center at Shanghai Jiao Tong University and principal investigator, said.
The SAFFRON trial enrolled patients with locally advanced or metastatic EGFR-mutated NSCLC whose tumors had high MET overexpression or amplification and who had progressed on prior TAGRISSO. The combination showed statistically significant and clinically meaningful improvements in both progression-free survival and overall survival versus chemotherapy, HUTCHMED said. The safety profile was consistent with the known profiles of each medicine, with no new safety findings.
MET-driven resistance is one of the most common mechanisms of resistance on third-generation EGFR-tyrosine kinase inhibitors, with an estimated 34 percent of tumors developing high MET overexpression or amplification after progression on such therapy. The trial ran across 230 centers in 29 countries, with patients receiving ORPATHYS at 300 milligrams twice daily plus TAGRISSO at 80 milligrams once daily.
The combination is already approved in China for patients with EGFR-mutated NSCLC with MET amplification after progression on EGFR-TKI therapy, based on the SACHI Phase III trial, and granted temporary authorization in Switzerland based on the SAVANNAH Phase II trial. In SACHI, the combination cut the risk of progression by 66 percent versus chemotherapy, with a median progression-free survival of 9.8 months versus 5.4 months.
HUTCHMED said the SAFFRON data will be presented at a forthcoming medical meeting and shared with global regulators to support potential registrations of the regimen. ORPATHYS is jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.
The positive readout strengthens the case for a biomarker-directed, all-oral option in a setting where roughly one in three patients develops MET-driven resistance, and it reinforces TAGRISSO as a backbone therapy across EGFR-mutated lung cancer. HUTCHMED, which trades on Nasdaq, AIM and the Hong Kong Stock Exchange, carries a Hold rating with a HK$21.30 price target, according to TipRanks. Investors will watch for full data at the upcoming medical meeting and any regulatory filings that follow.
This article is for informational purposes only and does not constitute investment advice.
