On December 12, Gelonghui reported that Hutchmed (China) (00013.HK) announced today that the Drug Evaluation Center of the National Medical Products Administration of China ("NMPA") has included Orpathys (savolitinib) and Tagrisso (osimertinib) in the list of breakthrough therapy drugs for the treatment of patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer who have disease progression after receiving Epidermal Growth Factor Receptor ("EGFR") inhibitor treatment with MET amplification. Orpathys is a potent, highly selective oral MET tyrosine kinase inhibitor ("TKI"). Tagrisso is an irreversible third-generation EGFR TKI.
This combination therapy is currently being evaluated in an ongoing multicenter, open-label, randomized controlled SACHI Phase III study in China. The study aims to explore the efficacy and safety of the combination of Tagrisso and Orpathys compared to the standard platinum-based doublet chemotherapy regimen (pemetrexed plus cisplatin or carboplatin) for EGFR mutation-positive patients with locally advanced or metastatic non-small cell lung cancer and disease progression after receiving EGFR inhibitor treatment with MET amplification. The primary endpoint of the study is progression-free survival ("PFS") assessed by the investigators. Other endpoints include PFS assessed by an Independent Review Committee, overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety (NCT05015608).
The NMPA's breakthrough therapy designation includes innovative drugs used for the prevention and treatment of serious life-threatening diseases for which there are no effective prevention and treatment methods or that have obvious clinical advantages compared to existing treatment methods. Drugs included in the breakthrough therapy designation can apply for conditional approval and priority review during the submission of new drug marketing applications. This inclusion may help accelerate the development and review speed of innovative therapies for this indication, thereby addressing the unmet needs of patients more quickly.
