TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer

Summary

In this randomized, double-blind, multicenter, phase III similarity study, treatment naive, EGFR wild-type, locally advanced, metastatic, or recurrent non-squamous, non-small cell, lung cancer (ns-NSCLC) patients were enrolled and randomized (1:1) into TAB008 or Bevacizumab-EU groups. Patients received TAB008 or bevacizumab-EU 15 mg/kg intravenously plus paclitaxel/carboplatin for 4-6 cycles followed by TAB008 or bevacizumab-EU 7.5 mg/kg until disease progression, unacceptable toxicity or death. The primary endpoint compared the objective response rate (ORR) within 6 cycles as read by an independent radiological review committee (IRRC). Secondary endpoints compared disease control rate (DCR) Within 6 cycles, duration of response (DoR), progression free survival (PFS), a year overall survival rate (OSR), overall survival (OS), safety, immunogenicity, and steady state pharmacokinetics.

Timeline

Start

2017-10-20

Primary completion

2020-03-24

Completion

2020-03-24

Outcome

Met primary endpoint

paper the ORR ratio was 1 (90% CI 0.89-1.14), well within the predefined equivalence margin of 0.75-1.33. PMID 36595042 ↗

release “randomized Phase III clinical trial of TAB008 (Pusintin ® ) has recently reached the predefined primary endpoint” biodlink.com ↗

Publications

• Lu S, Qin S, Zhou Z, Chen J, Gu K, Sun P, Pan Y, Yu G, Ma K, Shi J, Sun Y, Yang L, Chen P, Liu A, He J. Bevacizumab biosimilar candidate TAB008 compared to Avastin(R) in patients with locally advanced, metastatic EGFR wild-type non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter study. J Cancer Res Clin Oncol. 2023 Aug;149(9):5907-5914. doi: 10.1007/s00432-022-04563-4. Epub 2023 Jan 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	7.5 mg/kg	Intravenous
Subject	TAB008	Unknown	7.5 mg/kg	Intravenous

Indications

No indication recorded.