Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biopharmaceutical company, has announced positive results from the Phase III study (TQB2450-Ⅲ-05) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The study evaluated benmelstobart, with or without multi-target kinase inhibitor anlotinib, as a consolidation therapy for locally advanced/unresectable (stage III) non-small cell lung cancer (NSCLC) patients who have not progressed after synchronous/sequential radiotherapy and chemotherapy. The interim analysis showed that the primary endpoint of progression-free survival (PFS) has reached the pre-set optimal performance threshold.
Design and Significance of the Phase III Clinical Trial
The randomized, double-blind, double-dummy, placebo-controlled, multicenter Phase III clinical trial was designed to assess the efficacy and safety of benmelstobart with or without anlotinib as a consolidation therapy for locally advanced/unresectable (stage III) NSCLC patients. The study demonstrated that, compared to the control group, benmelstobart with or without anlotinib significantly prolonged the PFS of patients and significantly reduced their risk of disease progression or death.
Safety Profile and Consistency
The safety data from the trial is consistent with known risks, and no new safety signals were identified. This consistency in safety profile is crucial for the continued development and potential approval of benmelstobart as a treatment option for NSCLC patients.-Fineline Info & Tech
