HUTCHMED (China) announces that the New Drug Application (“NDA”) for the combination of ORPATHYS^® (savolitinib) and TAGRISSO^® (osimertinib) for the treatment of 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 has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”). ORPATHYS^® is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”). TAGRISSO^® is a third-generation, irreversible EGFR TKI. This acceptance also triggers a milestone payment from AstraZeneca.

The NDA is supported by data from SACHI, a multi-center, open-label, randomized, controlled, Phase III trial which evaluated 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 this setting. The primary endpoint of the study was progression free survival (“PFS”) as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety.

The Independent Data Monitoring Committee (“IDMC”) of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis and as a result, enrollment into the study has concluded. Results from SACHI will be submitted for presentation at an upcoming scientific conference (clinicaltrials.gov identifier NCT05015608).

“This marks the first regulatory filing for the ORPATHYS^® and TAGRISSO^® combination. The combination has demonstrated clear evidence to address MET-driven EGFR-inhibitor resistance and offers a continued path for oral treatment,” said Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. “With our biomarker-specific approach, we are hopeful to enhance treatment continuity and quality of life for NSCLC patients navigating this challenging journey. We and our partner AstraZeneca have been exploring this combination globally, through an array of late-stage clinical trials including the TATTON, SAVANNAH, SAFFRON and ORCHARD studies, and we hope to bring this all-oral, chemotherapy-free treatment option to patients with MET-driven lung cancer in the near future.”

The NMPA granted Breakthrough Therapy designation to the combination of ORPATHYS^® and TAGRISSO^® for this potential indication in December 2024. The NMPA granted this designation to this combination as a new treatment that could target a serious condition where clinical evidence demonstrates substantial advantages over existing therapies.