Objective
Anti-vascular endothelial growth factor (VEGF) monoclonal antibodies are an effective means of treating non-small cell lung cancer (NSCLC). Here, we aim to update the equivalent efficacy assessment between QL1101 and bevacizumab based on two-year follow-up data.
Methods
In total, 535 eligible NSCLC patients were enrolled in this randomized controlled trial. Patients were randomly assigned 1:1 to the QL1101 group and the bevacizumab group. The full end time of this study was defined as 24 months after the last enrolled patient was randomized. The primary endpoint was the objective response rate (ORR); equivalence was confirmed if the two-sided 90% confidence interval (90% CI) of the relative risk was within the range of 0.75−1.33. The secondary endpoints were progression-free survival (PFS) and overall survival (OS).
Results
The two-year updated data showed similar ORR (QL1101
vs.
bevacizumab: 53.1%
vs.
54.3%; relative risk=0.977; 90% CI: 0.838−1.144), PFS (235 d
vs.
254 d, log-rank P=0.311), and OS (577 d
vs.
641 d, log-rank P=0.099) results between the QL1101 group and the bevacizumab group. The mean shrinkage ratio of targeted lesions was also similar between the QL1101 group and the bevacizumab group (22.5%
vs.
23.5%). For patients who received QL1101 maintenance therapy, similar results were shown between the QL1101 group (n=157) and the bevacizumab group (n=148) (PFS: 253 d
vs.
272 d, log-rank P=0.387; OS: 673 d
vs
. 790 d, log-rank P=0.101; mean tumor shrinkage rate: 26.6%
vs.
27.5%).
Conclusions
This study reported that QL1101 had similar efficacy in treating nonsquamous NSCLC in terms of ORR, PFS and OS based on two-year updated data, providing a basis for the clinical application of QL1101.