Mabwell Highlights Results from the P-III Study of MW032 (Biosimilar, Denosumab) for Solid Tumors in JAMA Oncology
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- 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: PR Newswire | Image: Mabwell
Related News:- Mabwell Reports the US FDA’s IND Approval of 7MW3711 for the Treatment of Solid Tumors
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
