HUTCHMED (00013.HK): SAFFRON Phase III Data at ESMO; Combination Cuts Progression Risk by 45%

NewTimeSpace News: On 26 October 2026, HUTCHMED (China) Limited (stock code: 13) published a voluntary announcement that results from the global Phase III SAFFRON study were presented at the Presidential Symposium of the 2026 Congress of the European Society for Medical Oncology (ESMO) (abstract #LBA6) and published simultaneously in the New England Journal of Medicine.

The open-label, randomised, multicentre global Phase III study evaluated savolitinib (300 mg twice daily) plus osimertinib (80 mg once daily) versus platinum doublet chemotherapy in 338 patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer with MET overexpression and/or amplification whose disease had progressed on first- or second-line osimertinib, with progression-free survival (PFS) as the primary endpoint.

Median PFS by blinded independent central review was 7.6 months with the combination versus 5.4 months with chemotherapy, a 45% reduction in the risk of disease progression or death (HR 0.55; 95% CI 0.42-0.72; p<0.001); the 12-month PFS rates were 36% and 10% respectively. For the key secondary endpoint of overall survival (OS), median OS was 17.8 versus 12.9 months, an extension of 4.9 months and a 32% reduction in the risk of death (HR 0.68; 95% CI 0.50-0.91; p=0.010); 12-month OS rates were 70% and 53%. In the MET-overexpression set, median PFS was 8.5 versus 5.6 months (HR 0.51), and in the MET-amplification set 7.64 versus 4.2 months (HR 0.487, not formally tested).

Grade 3 or above treatment-emergent adverse events occurred in 64% of the combination arm versus 63% of the control arm, consistent with the known profiles of each agent, with no new safety issues identified; median total treatment duration was 8.5 versus 3.5 months. Based on the study, a new drug application for the combination has been submitted to the US FDA, with filings in Europe and Japan progressing as planned. Based on the SACHI study, the combination is already approved in China for EGFR TKI-treated advanced nonsquamous NSCLC with MET amplification.