Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trial

Tianqing Chu, et al.

Abstract


Objective: This phase 3 study aimed to test equivalence in efficacy and safety for QL1101, a bevacizumab analogue in Chinesepatients with untreated locally advanced non-squamous non-small cell lung cancer (NSCLC).

Methods: Eligible patients were randomly assigned 1:1 to receive carboplatin and paclitaxel in combination with either QL1101or bevacizumab, 15 mg/kg every 3-week for 6 cycles. This was followed by maintenance treatment with single agent QL1101 every3-week. The primary end-point was objective response rate (ORR), with secondary end-points being progression-free survival (PFS),overall survival (OS), disease control rate (DCR), and adverse events (AEs).

Results: Of 675 patients, 535 eligible patients were randomized to the QL1101 group (n = 269) and bevacizumab group (n =266). ORRs were 52.8% and 56.8%, respectively, for the QL1101 and bevacizumab groups, with an ORR hazard ratio 0.93 (95%confidence interval: 0.8–0131.1). The PFS, OS, DCR, and AEs were comparable between the 2 groups, which remained the same afterstratification according to epidermal growth factor receptor mutation or smoking history.

Conclusions: QL1101 showed similar efficacy and safety profiles as compared to bevacizumab among Chinese patients withuntreated locally advanced non-squamous NSCLC.


Keywords


Biosimilar; bevacizumab; equivalence; non-squamous NSCLC; clinical efficacy

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