HONG KONG – HUTCHMED (China) Limited (Nasdaq/AIM:HCM; HKEX:13) has received Breakthrough Therapy Designation (BTD) from China’s National Medical (TASE:) Products Administration (NMPA) for its combination treatment using ORPATHYS® and TAGRISSO®. This designation is for patients with advanced non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) mutations and have shown MET amplification after their disease progressed on EGFR inhibitor therapy.
The BTD was granted based on clinical evidence suggesting significant advantages over existing therapies for this life-threatening condition. The designation could lead to expedited development and review processes for the drug combination in China, potentially speeding up access for patients with unmet needs.
ORPATHYS® (savolitinib) is an oral MET tyrosine kinase inhibitor, while TAGRISSO® (osimertinib) is a third-generation EGFR inhibitor. Their combination is being assessed in the Phase III SACHI trial in China, which compares its efficacy and safety against the standard platinum-based doublet-chemotherapy for NSCLC patients with MET amplification after EGFR inhibitor therapy failure.
Lung cancer remains the leading cause of cancer death globally, with NSCLC making up the majority of cases. In Asia, 30-40% of NSCLC patients have EGFR mutations. MET aberrations, including overexpression and amplification, are a key mechanism of resistance to EGFR inhibitor therapy in NSCLC.
The combination of ORPATHYS® and TAGRISSO® has been studied in several trials, including the global Phase II SAVANNAH study, and is part of ongoing Phase III trials such as SACHI, SANOVO in China, and the global SAFFRON study. ORPATHYS® alone has already been conditionally approved in China for NSCLC patients with MET exon 14 skipping alterations post systemic therapy or who cannot receive chemotherapy.
This news is based on a press release statement from HUTCHMED. The company is focused on the discovery, development, and commercialization of cancer and immunological disease therapies, with several marketed medicines in China and ongoing developments worldwide.
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