HUTCHMED Submits New Drug Application (NDA) for ORPATHYS® (savolitinib) in Combination with TAGRISSO®
Thursday, January 02, 2025
HUTCHMED has announced that the China National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for the combination therapy of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib).
Lung cancer remains a leading cause of cancer-related deaths, with NSCLC comprising 80–85% of cases. Many patients are diagnosed at an advanced stage. Among NSCLC patients, a significant proportion have EGFR mutations, with higher rates reported in Asia compared to Western regions.
MET amplification is a common mechanism of resistance to EGFR TKIs, particularly osimertinib. Approximately 15–50% of patients whose disease progresses post-osimertinib therapy exhibit MET aberrations.
ORPATHYS® is the first selective MET inhibitor approved in China and has been included in the National Reimbursement Drug List since 2023. Its indications are expanding through supplementary regulatory submissions.
TAGRISSO® continues to be a widely used treatment for EGFR-mutated NSCLC globally.
This combination is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR mutations and MET amplification, following progression on first-line EGFR inhibitor therapy.
The application has been granted priority review status.
The combination therapy includes ORPATHYS®, a MET tyrosine kinase inhibitor, and TAGRISSO®, a third-generation EGFR TKI.
The NDA submission is backed by findings from the Phase III SACHI study, which compared the combination therapy to standard platinum-based chemotherapy in this patient group. The primary endpoint was progression-free survival (PFS), with additional endpoints such as overall survival, response rates, and safety.
The interim analysis confirmed the achievement of the primary endpoint, leading to the conclusion of patient enrolment.
The therapy targets resistance to EGFR inhibitors driven by MET amplification, offering an oral treatment option that avoids chemotherapy. Clinical trials, including TATTON, SAVANNAH, SAFFRON, and ORCHARD, have evaluated the combination globally.
The collaboration between AstraZeneca and HUTCHMED has facilitated the joint development and commercialisation of ORPATHYS®, with both companies contributing to advancing targeted therapies for cancer treatment.
Source: hutch-med.com
