On January 2, Gelong Hui reported that Hutchmed (China) (00013.HK) announced today that the new drug application for the combination therapy of Orpathys (savolitinib) and Tagrisso (osimertinib) for the treatment of EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer patients with disease progression after first-line epidermal growth factor receptor ("EGFR") inhibitor treatment, accompanied by MET amplification, has been accepted by the National Medical Products Administration of China ("NMPA") and granted priority review. Orpathys is a potent and highly selective oral MET tyrosine kinase inhibitor ("TKI"). Tagrisso is an irreversible third-generation EGFR TKI. This acceptance will also trigger a milestone payment from AstraZeneca.
Dr. Shi Ming, Head of R&D and Chief Medical Officer of Hutchmed (China), stated: "This is the first regulatory registration application for the combination therapy of Orpathys and Tagrisso. The combination therapy has demonstrated clear evidence in addressing the problem of MET-driven resistance to EGFR inhibitors and has made the continuation of oral medication possible. Through our biomarker-specific approach, we hope to improve treatment continuity and quality of life for non-small cell lung cancer patients to cope with this challenging journey. We and our partner AstraZeneca are exploring this combination therapy globally, conducting a series of late-stage clinical trials including TATTON, SAVANNAH, SAFFRON, and ORCHARD. We hope to bring this fully oral, chemotherapy-free treatment option to patients with MET-driven lung cancer in the near future."
