QL1101 Shows Similarity to Reference Bevacizumab in NSCLC in Phase 3 Trial

During last month’s European Society for Medical Oncology’s Asia 2018 annual meeting, held in Singapore from November 23 to November 25, researchers presented data demonstrating the biosimilarity of QL1101 with reference bevacizumab (Avastin).

QL1101 is a biosimilar product being developed by Chinese drug developer Qilu Pharmaceutical, which funded the phase 3 clinical trial that enrolled 532 patients with nonsquamous non—small-cell lung cancer (NSCLC). The objective of the study was to evaluate the effectiveness of the proposed biosimilar versus the reference bevacizumab.

The patients were randomized to receive either the proposed biosimilar (n = 266) or the reference product (n = 266), and both groups received their therapy in combination with paclitaxel and carboplatin every 3 weeks as a single treatment for 6 cycles. After the 6 cycles were completed, both groups received QL1101 as monotherapy maintenance treatment until disease progression, intolerable toxicity, initiation of a different treatment, loss to follow-up, or death. The primary end point was the best objective response rate (ORR) evaluated by the blind independent imaging review committee at week 18.

At week 18, the ORR of the biosimilar group was 52.26%, with 0 patients achieving a complete response (CR) and 139 patients achieving a partial response (PR). The ORR in the reference group was 56.02%, with 1 patient achieving CR, and 148 achieving PR. The risk ratio value was 0.917 (90% CI, 0.807-1.043), which fell within the prespecified equivalence margin of 0.75 to 1.33.

The researchers reported that the incidences of treatment-related adverse events (AEs) and immunogenicity were similar between the 2 treatment groups, and that no neutralizing antibodies to bevacizumab were detected. No unexpected serious AEs were observed.

The authors concluded that QL1101 and its reference are equivalent in clinical efficacy in nonsquamous NSCLC and that the safety profiles of the 2 drugs are similar.

Reference

Han B, Li K, Chu T, et al. A multi-center, randomized, double-blind, parallel, two-group phase iii trial on the efficacy and safety of QL1101 or bevacizumab in combination with paclitaxel and carboplatin in first-line treatment of non-squamous non-small cell lung cancer. Presented at: European Society for Medical Oncology Asia 2018 Congress; November 23-25, 2018; Singapore. Abstract 396O. cslide.ctimeetingtech.com/asia2018/attendee/confcal/session/calendar?q=biosimilar.