HUTCHMED announced positive interim results from its SACHI Phase III study, showing that the combination of savolitinib and osimertinib significantly improved progression-free survival (PFS) in patients with MET-amplified EGFR-mutant non-small cell lung cancersmall cell lung cancer (NSCLC) who progressed after first-line EGFR inhibitor therapy. The results were presented at the American Society of Clinical Oncology (ASCO) annual meeting. The study, conducted in China, offers a potential new treatment option for this patient population.
This positive data is crucial for patients with this specific type of lung cancer who have limited treatment options after progressing on initial EGFR inhibitor therapy. The SACHI trial results demonstrate that the savolitinib-osimertinib combination could offer a more effective and potentially less toxic alternative to chemotherapy, representing a substantial improvement in their prognosis. This advancement addresses a clear unmet medical need and could significantly improve the quality of life for these patients.
The interim analysis showed a median PFS of 8.2 months for the combination therapy versus 4.5 months for chemotherapy, as assessed by investigators (HR 0.34; p<0.0001). An independent review committee confirmed this significant PFS benefit. The objective response rate was also higher in the combination arm (58% vs. 34%). Importantly, the safety profile of the combination therapy was favorable and no new safety concerns were identified. Based on these positive results, a New Drug Application for the combination therapy has been accepted and granted priority review by the China NMPA. These findings suggest that the savolitinib-osimertinib combination could become a standard-of-care treatment for patients with MET-amplified EGFR-mutant NSCLC who have progressed on first-line EGFR inhibitors. Positive regulatory outcomes in China could pave the way for further global development and registration, potentially benefiting patients worldwide. The all-oral, chemotherapy-free regimen offers a convenient and well-tolerated option for patients, which is likely to improve patient compliance and quality of life.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
