HONG KONG - Hutchmed (China) Limited (Nasdaq/AIM:HCM; HKEX:13) has announced that the China National Medical (TASE:PMCN) Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for a combination therapy of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib). This combination is intended for patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET amplification after disease progression on first-line EGFR inhibitor therapy.
The NDA submission is based on data from the Phase III SACHI trial, which demonstrated the efficacy and safety of the ORPATHYS® and TAGRISSO® combination compared to platinum-based doublet-chemotherapy. This study reached its primary endpoint of progression-free survival (PFS) in a planned interim analysis, leading to the conclusion of enrollment.
Dr. Michael Shi, Head of R&D and Chief Medical Officer of Hutchmed, stated that this is the first regulatory filing for the combination therapy, noting its potential to address MET-driven EGFR-inhibitor resistance and provide an oral treatment pathway for NSCLC patients.
The NMPA's decision follows the Breakthrough Therapy designation awarded to the combination in December 2024, recognizing the potential substantial advantages over existing therapies for a serious condition.
NSCLC is the most common type of lung cancer, making up 80-85% of cases. MET aberrations, such as overexpression and/or amplification, are known to contribute to tumor growth and resistance to EGFR TKI in metastatic EGFR-mutated NSCLC, affecting a significant portion of patients who progress after treatment with drugs like osimertinib.
The combination of ORPATHYS® and TAGRISSO® has been studied in multiple late-stage trials, including TATTON and SAVANNAH, and is part of ongoing Phase III trials such as SACHI, SANOVO, and the global SAFFRON study. This development aims to provide a chemotherapy-free, biomarker-specific, and orally administered treatment option that balances efficacy, safety, and quality of life.
ORPATHYS® was conditionally approved in China for treating NSCLC with MET exon 14 skipping alterations and is the first selective MET inhibitor approved in the country. TAGRISSO® is a third-generation EGFR-TKI with a broad clinical application in NSCLC treatment.
This announcement, based on a press release statement, marks a significant step in NSCLC treatment in China, potentially offering new hope to patients with MET-driven lung cancer.
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