HUTCHMED introduced encouraging interim findings from the SACHI Phase III trial, indicating that the savolitinib and osimertinib duo notably extends progression-free survival in individuals facing advanced EGFR mutation-positive non-small cell lung cancer with MET amplification. Showcased at the 2025 ASCO Annual Meeting, these results present a chemotherapy-free treatment alternative characterized by a favorable safety profile.
Clinical Efficacy of Savolitinib and Osimertinib Combination
The SACHI study, encompassing 211 patients, revealed that those receiving the savolitinib and osimertinib combination experienced a median progression-free survival of 8.2 months compared to 4.5 months in the chemotherapy group, as assessed by investigators. Objective response rates also improved significantly, reaching 58% in the combination therapy cohort versus 34% with chemotherapy. Additionally, the disease control rate was 89% compared to 67%, and the median duration of response extended to 8.4 months from 3.2 months, underscoring the regimen’s robust anti-tumor activity.
Safety Profile and Regulatory Progress
The treatment combination maintained a tolerable safety profile, with grade 3 or higher adverse events reported in 57% of patients, matching the chemotherapy group’s occurrence. Notably, no new safety concerns emerged, reinforcing the regimen’s suitability for continued oral administration. These interim findings facilitated the closure of enrollment and propelled the New Drug Application for savolitinib and osimertinib to a priority review status by the China National Medical Products Administration, signaling swift regulatory consideration.
• The combination therapy could reshape treatment protocols for MET-amplified, EGFR-mutant NSCLC post-EGFR inhibitor therapy.
• The matching adverse event rates suggest that adding savolitinib does not increase the safety burden on patients.
• Rapid regulatory progression indicates strong confidence in the therapy’s efficacy and safety profile.
• Oral administration of the combination offers enhanced patient convenience and adherence compared to chemotherapy regimens.
The SACHI Phase III trial’s interim results mark a pivotal moment in managing EGFR-mutant NSCLC with MET amplification, offering a viable alternative to traditional chemotherapy. The demonstrated PFS benefit and consistent safety profile of the savolitinib and osimertinib combination not only address the pressing need for effective post-EGFR inhibitor therapies but also extend treatment options with oral, patient-friendly regimens. HUTCHMED’s strategic focus on targeted therapies is validated through these findings, potentially setting a new standard of care and accelerating the pathway towards improved patient outcomes in a challenging cancer subset.
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