HUTCHMED (00013) announces submission of a U.S. New Drug Application for ORPATHYS (savolitinib) in combination with TAGRISSO (osimertinib) for the treatment of MET-driven EGFR-mutated lung cancer

HUTCHMED (00013) announced that AstraZeneca has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the combination therapy of ORPATHYS (savolitinib) and TAGRISSO (osimertinib), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or amplification whose disease has progressed during or after treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The New Drug Application is supported by data from the SAFFRON global Phase III study. The SAFFRON study showed that the combination therapy of ORPATHYS and TAGRISSO demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with platinum-based doublet chemotherapy in patients whose disease had progressed after treatment with TAGRISSO. The safety profile of the combination therapy was consistent with the known safety profiles of each drug, and no new safety concerns were identified. The results will be presented at the Presidential Symposium session of the upcoming 2026 European Society for Medical Oncology (ESMO) Annual Meeting. Third-generation EGFR tyrosine kinase inhibitors (TKIs) have significantly improved treatment outcomes for patients with EGFR-mutated non-small cell lung cancer. However, MET overexpression or amplification is one of the most common mechanisms of resistance following treatment with third-generation EGFR TKIs. MET-driven resistance is often associated with poorer prognosis, and there remains a significant unmet clinical need for effective and well-tolerated treatment options in the later-line treatment setting. Mr. Zheng Zefeng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said: "Following the approval of the combination therapy of ORPATHYS and TAGRISSO in China based on the SACHI Phase III study, this marketing application submission is an important step in bringing this combination therapy to patients in the United States. The success of the SAFFRON global Phase III study is the result of HUTCHMED's long-term collaboration with AstraZeneca to provide a solution for MET-driven resistance in EGFR-mutated lung cancer. We will continue to fully support the regulatory review process and are committed to providing this biomarker-driven, chemotherapy-free oral combination therapy to appropriate patients." It is reported that ORPATHYS is co-developed by AstraZeneca and HUTCHMED, and is commercialized by AstraZeneca.