Mabwell Highlights Results from the P-III Study of MW032 (biosimilar, denosumab) for Solid Tumors in JAMA Oncology 

Shots: 

• The results from the P-III trial comparing MW032’s (SC, Q4W, until wk. 49) safety, efficacy & PK vs reference drug (denosumab) to treat patients (n=708), randomized 1:1, with solid tumors having bone metastasis are published in JAMA Oncology 

• The 1EP includes percentage change in natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr) from baseline to wk.13 and 2EPs are percentage change from baseline to wks. 5, 13, 25, 37 & 53 of uNTx/uCr & bone-specific alkaline phosphatase (s-BALP) as well as the incidence of SREs 

• The study depicted a mean change of −72.0% in uNTx/uCr with MW032 vs −72.7% having an LSM difference of 0.02 and established the biosimilarity b/w MW032 & denosumab 

Ref:  | Image: | Press Release

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