Sino Biopharmaceutical Ltd (HKG: 1177), a China-based pharmaceutical giant, has announced the completion of patient enrollment for a Phase III clinical trial of anlotinib, marketed under the trade name FOCUS V, in conjunction with chemotherapy for first-line treatment of advanced soft tissue sarcoma. The trial, conducted by Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd., a subsidiary of Sino Biopharmaceutical, is a multi-center, randomized, double-blind, and parallel controlled study aimed at evaluating the efficacy and safety of anlotinib combined with epirubicin versus a placebo combined with epirubicin for the treatment of advanced soft tissue sarcoma.
Early Phase I clinical results for the combination therapy in first-line advanced soft tissue sarcoma were promising, with an objective response rate (ORR) of 13.3%, a disease control rate (DCR) of 80%, and a median progression-free survival (mPFS) of 11.5 months. The therapy was also found to be safe and well-tolerated. Anlotinib, an oral multi-target kinase inhibitor, gained approval in China in May 2018 for the treatment of previously treated advanced non-small cell lung cancer and has since received additional indications for soft tissue sarcoma, small cell lung cancer, medullary thyroid carcinoma, and differentiated thyroid carcinoma. The drug is currently awaiting regulatory decisions in China for the treatment of first-line small cell lung cancer (SCLC) in combination with anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart and chemotherapy.- Fineline.com
