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|Authors||S Tjulandin, M Fedyanin, L Demidov, V Moiseyenko, S Protsenko, S Odintsova, T Y Semiglazova, R Zukov, S Lazarev, A Andreev, M Nechaeva, J Makarova, N Fadeeva, A Tarasova, O Kozlova, M Shustova, A Garipov, R Ivanov|
|Title||Final results of phase II trial (MIRACULUM) of the novel PD-1 inhibitor prolgolimab in patients with advanced melanoma|
|Journal||Annals of Oncology|
|Abstract Text||Annals of Oncology, Volume 30, Issue Supplement_11, December 2019, Abstract 119P|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Therapy Name||Drugs||Efficacy Evidence||Clinical Trials|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Prolgolimab||BCD-100||PD-L1/PD-1 antibody 63||Prolgolimab (BCD-100) is a monoclonal antibody against PD-1, which may promote anti-tumor immune response (Annals of Oncology, Volume 30, Issue Supplement_11, December 2019, Abstract 119P, PMID: 31847708).|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||melanoma||not applicable||Prolgolimab||Phase II||Actionable||In a Phase II trial (MIRACULUM), Prolgolimab demonstrated safety and preliminary efficacy, resulted in an objective response rate (ORR) of 38% (24/63, 5 complete response (CR), 19 partial response (PR)) and a disease control rate (DCR) of 64% when administered at 1mg/kg Q2W, and an ORR of 29% (18/63, 2 CR, 16 PR) with a DCR of 46% when administered at 3mg/kg Q3W, in patients with advanced melanoma (Annals of Oncology, Volume 30, Issue Supplement_11, December 2019, Abstract 119P; NCT03269565).||detail...|