China-based Chia Tai Tianqing Pharmaceutical, a subsidiary of Sino Biopharmaceutical Ltd (HKG: 1177), has announced positive readouts from the Phase III TQB2450-Ⅲ-12 study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) combined with the multi-target kinase inhibitor anlotinib.
Phase III Study Design and Outcomes
The multi-center, randomized, double-blinded, parallel-controlled Phase III study aimed to assess the efficacy and safety of benmelstobart combined with chemotherapy followed by sequential therapy combined with anlotinib in first-line advanced squamous non-small cell lung cancer (sq SCLC) versus tislelizumab combined with chemotherapy. The study met the primary endpoint of progression-free survival, reaching the optimal efficacy threshold set by the protocol. The safety profile of the combination is consistent with previous reports.
Mechanism of Action and Therapeutic Potential
Benmelstobart works by preventing PD-L1 from binding to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and enhancing the immune response. Anlotinib targets VEGFR, PDGFR, FGFR, and c-Kit, generating anti-angiogenetic effects and inhibiting tumor growth. Anlotinib previously obtained marketing approval to treat previously treated advanced non-small cell lung cancer (NSCLC) in China in May 2018, followed by additional indications in soft tissue sarcoma, SCLC, medullary thyroid carcinoma, differentiated thyroid carcinoma, and extensive-stage small cell lung cancer (ES-SCLC).
Previous Approvals and Future Applications
Benmelstobart combined with anlotinib was previously approved in China to treat, when combined with chemotherapy, first-line extensive-stage small cell lung cancer (ES-SCLC) and previously treated non microsatellite instability-high (non-MSI-H) or non-mismatch repair deficiency (non-dMMR) recurrent or metastatic endometrial cancer in April and November of this year, respectively. The combination is expected to apply for market approval for additional indications in the country in the near future.-Fineline Info & Tech
