HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN), has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). The designation is for the use of Orpathys in combination with 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 who have experienced disease progression on EGFR inhibitor therapy.
Orpathys: A Selective MET Inhibitor in China
Orpathys was conditionally approved in China in June 2021 for the treatment of locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, making it the first selective MET inhibitor in the country. The partnership between HutchMed and AstraZeneca (AZ) began in 2011 to co-develop the drug and enhance its commercial prospects.
Tagrisso: A Third-Generation EGFR-TKI with Multiple Indications in China
Tagrisso, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), has received four indication approvals in China. These include second-line treatment of NSCLC previously treated with EGFR-TKI and with EGFR T790M mutation, first-line treatment of EGFR-mutated NSCLC with exon 19 deletions or exon 21 mutations, adjuvant therapy for EGFR-mutated stage IB-IIIA NSCLC with exon 19 deletions or exon 21 mutations post-curative surgery, and first-line treatment in combination with chemotherapy for locally advanced or metastatic EGFR-mutated NSCLC with exon 19 deletions or exon 21 mutations.
Phase III SACHI Study Assessing Combination Therapy
The combination of Orpathys and Tagrisso is currently being evaluated in the Phase III SACHI study (NCT05015608) in China for its efficacy and safety compared to the current standard of care in patients with EGFR mutation-positive NSCLC with MET amplification after disease progression on any EGFR inhibitor therapy. The primary endpoint of the study is progression-free survival (PFS) as assessed by the investigators. Additional endpoints include PFS evaluated 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.-Fineline Info & Tech
