HUTCHMED 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 submission is supported by data from the global Phase III SAFFRON study. The SAFFRON study showed that the combination 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 TAGRISSO® treatment. The safety profile of the combination was consistent with the known safety profiles of each drug, and no new safety issues were identified. The results will be presented at the Presidential Symposium at 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-mutant non-small cell lung cancer. However, MET overexpression or amplification is one of the most common mechanisms of resistance following third-generation EGFR TKI treatment. MET-driven resistance is often associated with a poorer prognosis, and there remains a substantial 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 of ORPATHYS® and TAGRISSO® in China based on the SACHI Phase III study, this submission represents an important step toward bringing this combination therapy to patients in the United States. The success of the global Phase III SAFFRON study is the result of HUTCHMED's long-term collaboration with AstraZeneca to provide solutions for MET-driven resistance in EGFR-mutant lung cancer. We will continue to fully support the regulatory review process and are committed to providing this biomarker-directed, chemotherapy-free oral combination therapy to appropriate patients."

It is reported that ORPATHYS® is jointly developed by AstraZeneca and HUTCHMED, and is commercialized by AstraZeneca.