LONDON (dpa-AFX) - HUTCHMED (China) Limited (HCM) announced that the Center for Drug Evaluation of Chinas National Medical Products Administration or NMPA has granted Breakthrough Therapy Designation (BTD) to the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib).
The BTD is given for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutationpositive nonsmall cell lung cancer (NSCLC) with MET amplification after disease progression on EGFR inhibitor therapy.
ORPATHYS is an oral, potent and highly selective MET tyrosine kinase inhibitor (TKI). TAGRISSO is a third-generation, irreversible EGFR TKI.
The commercial-stage, biopharmaceutical company said the treatment combination is being evaluated in China in the ongoing multi-center, open-label, randomized, controlled, Phase III SACHI trial.
The study is investigating the efficacy and safety of a combination of ORPATHYS and TAGRISSO compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the standard of care treatment option, in patients with locally advanced or metastatic NSCLC with MET amplification after failure of EGFR inhibitor therapy.
HUTCHMED noted that the primary endpoint of the study is progression-free survival (PFS) as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, overall survival, objective response rate, and safety, among others.
In 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize ORPATHYS. Joint development of ORPATHYS in China is led by HUTCHMED, while AstraZeneca leads development outside of China.
Sales of ORPATHYS are recognized by AstraZeneca.
Further, AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.
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