Denosumab biosimilar appears safe, effective in bone metastases from solid tumors
Denosumab biosimilar QL1206 was found to have promising efficacy and a tolerable safety profile in in patients with bone metastases from solid tumors, according to results of a Phase 3 trial. The biosimilar was also found to have pharmacokinetics equivalent to denosumab.
In this randomized, double-blind trial, 717 patients with solid tumors and bone metastases were randomly assigned to 3 doses of QL1206 (n = 357) or denosumab subcutaneously every 4 weeks (n = 360). The primary endpoint was percentage change in urinary N-telopeptide/creatinine ratio (uNTX/uCr) from baseline to week 13.
At week 13, the median percentage change in uNTX/uCr was -75.2% in the QL1206 group and -75.8%, in the denosumab group.
From week 13 to baseline, the least-squares mean difference in the natural log-transformed ratio of uNTX/uCr was 0.012 between groups, within the equivalence margins of ± 0.135.
There were no differences between groups in the secondary endpoints, including percentage change in uNTX/uCr at week 25 and 53, percentage change in serum bone-specific alkaline phosphatase at week 13, 25, and 53, and time to on-study skeletal-related events.
Li H, Huang Y, Chen Z, et al. Efficacy and Safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients with Bone Metastases from Solid Tumors: A Randomized Phase III Trial. BioDrugs. 2023 Feb 21. doi: 10.1007/s40259-023-00579-5. Epub ahead of print. PMID: 36802320.