HUTCHMED (China) Limited (HCM) recently announced that the Center for Drug Evaluation at China's National Medical Products Administration (NMPA) has awarded Breakthrough Therapy Designation (BTD) to the drug combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib).
This designation is specifically granted for treating patients experiencing locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation. This condition includes MET amplification following disease progression despite EGFR inhibitor therapy.
ORPATHYS is an orally administered, potent, and highly selective MET tyrosine kinase inhibitor (TKI). Conversely, TAGRISSO is a third-generation, irreversible EGFR TKI.
HUTCHMED, a commercial-stage biopharmaceutical company, is currently evaluating this treatment combination within China as part of the ongoing Phase III SACHI trial. This multi-center, open-label, randomized, controlled study is examining the efficacy and safety of the combination compared to the standard-care treatment option of platinum-based doublet chemotherapy—which includes pemetrexed plus either cisplatin or carboplatin—in patients with locally advanced or metastatic NSCLC with MET amplification following failure of EGFR inhibitor therapy.
The primary endpoint for this study is progression-free survival (PFS), as assessed by investigators. Other measured outcomes encompass PFS evaluated by an independent review committee, overall survival rates, objective response rates, and various safety metrics.
In 2011, AstraZeneca and HUTCHMED initiated a global licensing and collaboration agreement for the joint development and commercialization of ORPATHYS. While HUTCHMED leads development efforts within China, AstraZeneca oversees efforts beyond China’s borders. Sales of ORPATHYS are reported by AstraZeneca. Additionally, AstraZeneca continues to investigate TAGRISSO as a therapeutic option for patients at various stages of EGFRm NSCLC.
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