Shiyao Group (01093): A phase III clinical trial of JMT101 combined with ositinib for first-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR20 exon insertion mutation achieved positive top-line results

Zhitong Finance App News, Shiyao Group (01093) announced that the Phase III clinical trial developed by the Group for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying the epidermal growth factor receptor (EGFR) exon 20 mutation (EGFR ex20ins) reached the main endpoint in the predetermined mid-term analysis and obtained positive top line results. JMT101 Compared with platinum plus pemetrexed chemotherapy, this product in combination with osidinib significantly lengthened patients' progression-free survival (PFS) and showed a trend of overall survival (OS) benefits.

This trial is a randomized, open, parallel-controlled phase III clinical trial to compare the efficacy and safety of this product in combination with ositinib and platinum plus pemetrexed in first-line treatment of these patients. The primary endpoint was PFS as assessed by the Independent Review Committee (IRC) based on the Solid Tumor Efficacy Evaluation Criteria (RECIST 1.1). According to the pre-set statistical analysis plan, after review and resolution by the Independent Data Monitoring Committee (IDMC), the PFS benefits of this product combined with the osimitinib treatment group reached the statistical efficacy threshold set by mid-term analysis, and had significant clinical significance. Furthermore, the combined treatment regimen has good safety.