10Feb 2024
Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared to Denosumab for Solid Tumor–Related Bone Metastases

Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared to Denosumab for Solid Tumor–Related Bone Metastases

A 53-week, multicenter, head-to-head trial studied the bioequivalence of MW032, a denosumab biosimilar, for solid tumor-related bone metastases. Among 701 patients, ages 22-86, the MW032 group showed a mean uNTx/uCr change of -72.0%, similar to denosumab (-72.7%), meeting equivalence criteria. Changes in bone-specific markers were consistent over 53 weeks. No significant differences were found in skeletal-related event incidence or time to first event between MW032 and denosumab groups. This study confirms MW032's efficacy, pharmacokinetics, and safety akin to denosumab, potentially enhancing denosumab accessibility for advanced tumor patients.

  • #oncology

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