Hutchmed (China) (HCM) and AstraZeneca (AZN) have initiated SACHI, a China Phase III study of Orpathys (savolitinib) in combination with AstraZeneca’s Tagrisso (osimertinib) for the treatment of patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC) with MET amplification after disease progression on EGFR inhibitor therapy.
The first patient received their first dose on November 22, 2021.
The study will evaluate the efficacy and safety of Orpathys in combination with Tagrisso, compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the standard-of-care treatment option in this setting.
The primary endpoint is median progression free survival (PFS) as assessed by investigators. Other endpoints include median PFS assessed by an independent review committee, median overall survival, objective response rate, duration of response, disease control rate, time to response, and safety.