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, Jun Lu, Minghong Bi, Helong Zhang, Wu Zhuang, Yan Yu, Jianhua Shi, Zhendong Chen, Xiaochun Zhang, Qisen Guo, Quan Liu, Huijuan Wu, Jian Fang, Yi Hu, Xiuwen Wang, Cuicui Han, Kai Li, Baohui Han, Tianqing Chu, Jun Lu, Minghong Bi, Helong Zhang, Wu Zhuang, Yan Yu, Jianhua Shi, Zhendong Chen, Xiaochun Zhang, Qisen Guo, Quan Liu, Huijuan Wu, Jian Fang, Yi Hu, Xiuwen Wang, Cuicui Han, Kai Li, Baohui Han

Abstract

Objective: This phase 3 study aimed to test equivalence in efficacy and safety for QL1101, a bevacizumab analogue in Chinese patients 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 QL1101 or bevacizumab, 15 mg/kg every 3-week for 6 cycles. This was followed by maintenance treatment with single agent QL1101 every 3-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 after stratification 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 with untreated locally advanced non-squamous NSCLC.

Keywords: Biosimilar; bevacizumab; clinical efficacy; equivalence; non-squamous NSCLC.

Conflict of interest statement

This study was supported by Qilu Pharmaceutical Group Co, Ltd. No other potential conflicts of interests are disclosed.

Copyright © 2021 Cancer Biology & Medicine.

Figures

Figure 1
Figure 1
Study flowchart.
Figure 2
Figure 2
Equivalent therapeutic efficacy and safety were demonstrated between QL1101 and bevacizumab. (A) Similarity between QL1101 and bevacizumab was evaluated for the end-points of partial response, stable disease, progressive disease, not evaluated, complete response, and objective response rate. (B) Equivalence between QL1101 and bevacizumab was compared for safety including any treatment emergent adverse events (TEAEs), any serious TEAEs, any CTCAE ≥ 3 TEAE, any CTCAE ≥ 3 adverse drug response (ADR), neutrophil reduction, and leukopenia. (C, D) Similarities between QL1101 and bevacizumab were evaluated for the progression-free survival and overall survival end-points.
Figure 3
Figure 3
Evaluation of equivalent therapeutic efficacy after excluding interference factors. (A) Equivalent overall survival (OS) evaluation in EGFR-mutated patients, excluding patients with a history of smoking and tumors. (B) After excluding the interference factors, better equivalence between QL1101 and bevacizumab was observed for the end-points of partial response, stable disease, progressive disease, not evaluated, complete response, and objective response rate. (C, D) After excluding interference factors, better equivalence between QL1101 and bevacizumab was found for the end-points of progression-free survival and overall survival.

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Source: PubMed

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