HUTCHMED Gains China Approval for ORPATHYS® and TAGRISSO® Combo in MET-Amplified Lung Cancer Patients

HUTCHMED (China) Limited recently announced a significant advancement in cancer treatment with the approval from the China National Medical Products Administration (NMPA) for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib). This new treatment regimen is designed for patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-squamous non-small cell lung cancer (NSCLC) that have developed MET amplification following disease progression on EGFR tyrosine kinase inhibitor (TKI) therapy. The approval marks a pivotal moment in the ongoing battle against lung cancer in China, particularly for those with EGFR mutations.

ORPATHYS®, known for being the first selective MET inhibitor approved in China, is a potent and highly selective MET TKI. TAGRISSO®, on the other hand, is an irreversible, third-generation EGFR TKI. The combination therapy was evaluated in the Phase III SACHI trial, which demonstrated that it significantly reduced the risk of disease progression or death by 66% compared to standard platinum-based chemotherapy. This study formed the basis for the recent approval, highlighting a median progression-free survival (PFS) of 8.2 months with the combination therapy, compared to only 4.5 months with chemotherapy.

The results of the SACHI trial were presented during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2025. These findings underscore the potential of this combination therapy to offer a continued, all-oral treatment regimen for patients, bypassing the need for chemotherapy. The approval culminated in a US$11 million milestone payment to HUTCHMED from AstraZeneca, which markets both drugs in China.

Professor Shun Lu, a leading figure in lung cancer research and the principal investigator of the SACHI trial, emphasized the significance of this approval in tackling the challenges of lung cancer treatment in China. He expressed optimism that the new combination therapy could enhance treatment outcomes and quality of life for patients dealing with this critical resistance mechanism.

HUTCHMED’s CEO, Dr. Weiguo Su, highlighted the collaboration with AstraZeneca as a crucial factor in achieving this milestone. He reiterated the commitment to advancing this partnership and exploring further treatment settings to expand the reach of the ORPATHYS® and TAGRISSO® combination.

In lung cancer, MET aberrations are a significant factor in tumor growth and resistance to treatment. MET, a receptor tyrosine kinase, plays a crucial role in normal cell development, and its overexpression or amplification can lead to cancer progression. The approval of the ORPATHYS® and TAGRISSO® combination offers a new avenue to address these mechanisms in EGFR-mutated NSCLC.

ORPATHYS® and TAGRISSO®'s development has been a focal point in the field, with several studies, including the TATTON and SAVANNAH trials, providing promising results. These studies have paved the way for the SACHI trial and further global trials like the SAFFRON trial, which aims to establish the efficacy of this combination therapy on an international scale.

HUTCHMED, as an innovative biopharmaceutical company, remains dedicated to the discovery and development of targeted therapies. This recent approval is a testament to their commitment to improving cancer treatment and expanding access to these therapies globally. Through continued research and collaboration, HUTCHMED aims to make strides in oncology care, delivering new hope to patients confronting the complex challenges of lung cancer.