CSPC Pharmaceutical Group Limited (CSPC Pharma) announced that its Phase III study evaluating Becotatug (JMT101) combined with osimertinib as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations has achieved the primary endpoint at a pre-specified interim analysis.

The randomized, open-label trial compared the dual-targeted, chemotherapy-free regimen of Becotatug plus osimertinib against standard platinum-based chemotherapy plus pemetrexed. Independent Review Committee assessment, based on RECIST 1.1 criteria, confirmed a statistically significant and clinically meaningful improvement in progression-free survival for the investigational arm. The Independent Data Monitoring Committee verified that the PFS benefit crossed the predefined superiority boundary. A favorable safety profile was also observed, and an overall-survival improvement trend was noted.

Becotatug is a high-affinity, humanized monoclonal antibody targeting EGFR. When paired with the EGFR tyrosine kinase inhibitor osimertinib, the combination simultaneously blocks extracellular and intracellular EGFR signaling, offering a novel chemotherapy-free approach in this patient population.

CSPC Pharma intends to present full study data at forthcoming academic conferences. The company is also pursuing pivotal Phase III trials of Becotatug for additional indications, including first-line treatment of locally advanced or metastatic non-squamous NSCLC with classical EGFR mutations and advanced metastatic colorectal cancer after failure of at least two standard therapies.