Ygalo (melphalan-flufenamide; Oncopeptides) is a cytotoxic alkylating agent that consists of melphalan conjugated to phenylalanine. By utilizing peptidases that are overexpressed in malignant cells, Ygalo undergoes intracellular cleavage and provides targeted delivery of melphalan.
Ygalo is being introduced as a novel dipeptide prodrug of the alkylating agent melphalan with a mechanism of action designed to overcome melphalan’s association with toxicities and drug resistance. Topline Phase II results (ClinicalTrials.gov identifier: NCT02963493) in heavily pre-treated multiple myeloma patients are encouraging, with an overall response rate of 30%, a clinical benefit rate of 40%, and a good safety and tolerability profile. However, data from Ygalo’s head-to-head Phase III OCEAN trial (ClinicalTrials.gov identifier: NCT03151811) against Pomalyst (pomalidomide; Celgene) will be critical in determining future uptake for heavily pre-treated relapsed/refractory patients.
LIST OF FIGURES
10 Figure 1: Ygalo for multiple myeloma – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary for Ygalo in multiple myeloma
12 Figure 3: Datamonitor Healthcare’s drug assessment summary for Ygalo for multiple myeloma
14 Figure 4: Ygalo sales for multiple myeloma across the US and five major EU markets, by country, 2017–26
LIST OF TABLES
5 Table 1: Ygalo drug profile
7 Table 2: Ygalo Phase III trial in multiple myeloma
9 Table 3: Ygalo early-phase data in multiple myeloma
15 Table 4: Ygalo sales for multiple myeloma across the US and five major EU markets, by country ($m), 2017–26
17 Table 5: Patients treated with Ygalo in the US and five major EU markets, by country, 2017–26
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