Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review a new indication filing for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), benmelstobart (TQB2450). The filing seeks regulatory approval for the use of benmelstobart in combination with anlotinib as a first-line treatment for patients with advanced unresectable or metastatic renal cell carcinoma (RCC).
The submission is supported by positive results from the Phase III ETER100 study, which demonstrated that the combination therapy significantly improved progression-free survival (PFS) compared to sunitinib in first-line advanced RCC patients. Additionally, the study showed improvements in objective response rate (ORR) and overall survival (OS), which were secondary endpoints.
Benmelstobart received marketing approval in China in May of this year for the treatment of first-line extensive stage small cell lung cancer (ES-SCLC) in combination with anlotinib and chemotherapy. Anlotinib, an oral multi-target kinase inhibitor, was initially approved in China in May 2018 for the treatment of previously treated advanced non-small cell lung cancer (NSCLC) and has since received additional approvals for soft tissue sarcoma, SCLC, medullary thyroid carcinoma, differentiated thyroid carcinoma, and ES-SCLC. The combination of benmelstobart and anlotinib is also under regulatory review in China for the treatment of recurrent or metastatic endometrial cancer.- Flcube.com
