Summary of Clinical Use

Benmelstobart (TQB2450) was progressed to clinical studies to evaluate safety and efficacy in various types of solid tumours [2-6], most commonly in comination with catequentinib (a.k.a. anlotinib) or other kinase inhibitors. The Chinese drug regulator (NMPA) approved benmelstobart (Andervi®) in May 2024 as first-line treatment for extensive-stage small cell lung cancer, in combination with catequentinib. NMPA approval for this combination therapy was expanded in November 2024 to include treament of recurrent or metastatic endometrial cancer.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT03996408	Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma	Phase 1/Phase 2 Interventional	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.		6
NCT03825705	A Study on Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Patients With Advanced Biliary Adenocarcinoma/Hepatocellular Carcinoma	Phase 1/Phase 2 Interventional	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.		6
NCT04964479	A Clinical Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus K Drug in the Treatment of First-line Non-small Cell Lung Cancer(NSCLC)	Phase 3 Interventional	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.		5
NCT04234607	A Study of TQB2450 or Placebo Combined With Anlotinib, Etoposide and Carboplatin Versus Etoposide and Carboplatin in Subjects With Extensive Small Cell Lung Cancer (ETER701)	Phase 3 Interventional	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.		1