CSPC PHARMA (01093) has announced that the Phase III clinical trial of its developed becotatug (JMT101) in combination with osimertinib for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (EGFR ex20ins) has met its primary endpoint in a pre-specified interim analysis, yielding positive topline results.

Compared with platinum-based chemotherapy combined with pemetrexed, the combination regimen of this product with osimertinib significantly prolonged patients' progression-free survival (PFS) and demonstrated a trend toward overall survival (OS) benefit.

This trial is a randomized, open-label, parallel-controlled Phase III clinical study designed to compare the efficacy and safety of this product combined with osimertinib versus platinum-based chemotherapy combined with pemetrexed as first-line treatment for the aforementioned patient population. The primary endpoint is PFS assessed by an independent review committee (IRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

According to the pre-specified statistical analysis plan, following review and resolution by the independent data monitoring committee (IDMC), the PFS benefit in the combination treatment group reached the pre-specified statistical superiority boundary for the interim analysis and demonstrated significant clinical meaningfulness. Additionally, the combination regimen showed a favorable safety profile.