Hutchmed reports positive Phase III SAFFRON trial results for lung cancer therapy

Hutchmed has announced positive results from its global Phase III SAFFRON study, presented at the European Society for Medical Oncology (ESMO) annual meeting and published in the New England Journal of Medicine. The study evaluated a combination therapy of Orpathys (savolitinib) and Tagrisso (osimertinib) for patients with EGFR-mutant non-small cell lung cancer (NSCLC) experiencing MET-driven resistance after prior treatment with Tagrisso.

Compared to platinum-based doublet chemotherapy, the combination therapy reduced the risk of disease progression or death by 45%. The median progression-free survival (PFS) was 7.6 months for the combination group versus 5.4 months for the chemotherapy group. Additionally, the study showed a 32% reduction in the risk of death, with median overall survival (OS) extended to 17.8 months compared to 12.9 months in the control group.

Based on these findings, Hutchmed has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). Applications in Europe and Japan are also proceeding as planned. The therapy has already been approved in China for specific patients with MET amplification following EGFR-TKI treatment.