CSPC PHARMA(01093): Positive topline results from the Phase III clinical trial of JMT101 combined with osimertinib as first-line treatment for locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations

CSPC PHARMA (01093) announced that the Phase III clinical trial of becotatug (JMT101) combined with osimertinib as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (EGFR ex20ins), developed by the Group, met its primary endpoint in the prespecified interim analysis, achieving positive topline results. Compared with platinum-based chemotherapy combined with pemetrexed, the treatment regimen of this product combined with osimertinib significantly prolonged patients' progression-free survival (PFS) and showed a trend of benefit in overall survival (OS). This trial is a randomized, open-label, parallel-controlled Phase III clinical trial designed to compare the efficacy and safety of this product combined with osimertinib versus platinum-based chemotherapy combined with pemetrexed in the first-line treatment of the aforementioned patients. The primary endpoint is PFS assessed by the Independent Review Committee (IRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). According to the prespecified statistical analysis plan, following review and resolution by the Independent Data Monitoring Committee (IDMC), the PFS benefit in the this product combined with osimertinib treatment group reached the prespecified statistical superiority boundary for the interim analysis and demonstrated significant clinical significance. In addition, the combined treatment regimen has shown a favorable safety profile.