On June 30, 2025，HUTCHMED announces that the New Drug Application (NDA) for the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) has been granted approval by the China National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-squamous non-small cell lung cancer (NSCLC) with MET amplification after disease progression on EGFR tyrosine kinase inhibitor (TKI) therapy. ORPATHYS is an oral, potent and highly selective MET TKI. TAGRISSO is a third-generation, irreversible EGFR TKI.
ORPATHYS was the first selective MET inhibitor approved in China, indicated for adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration. This new approval by the NMPA was based on data from the SACHI Phase III trial of the ORPATHYS and TAGRISSO combination (NCT05015608), having met the pre-defined primary endpoint of progression-free survival (PFS) in a pre-planned interim analysis. Primary results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2025.
As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination or chemotherapy. In the intention to treat (ITT) population, the median progression-free survival (PFS) assessed by investigator was 8.2 months with savolitinib plus osimertinib, compared to 4.5 months with chemotherapy . The independent review committee (IRC) assessed median PFS was 7.2 months vs 4.2 months, respectively.
The investigator-assessed objective response rate (ORR) was 58% in the savolitinib plus osimertinib group compared to 34% for patients in the chemotherapy group. The disease control rate (DCR) was 89% vs 67% and the median duration of response (DoR) was 8.4 months vs 3.2 months, respectively. Overall survival was not mature at the time of the interim analysis.
Efficacy outcomes in the third-generation EGFR tyrosine kinase inhibitor (TKI)–treated patients were comparable with those in the intention-to-treat and third-generation EGFR-TKI–naïve populations. In the third generation EGFR-TKI–treated subgroup, the investigator-assessed and IRC-assessed median PFS were highly consistent, both at 6.9 vs 3.0 months.
The safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib group compared to 57% for patients in the chemotherapy group, suggesting a favorable safety profile.
About ORPATHYS
ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.®
About TAGRISSO®
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat nearly 800,000 patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
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Post time: Jul-03-2025