Promacta/Revolade in new Phase III trial for Cytopenias-GSK

Glaxo Smith Kline has announced the start of a Phase III study, SUPPORT (TRC112121), to evaluate the platelet supportive care effects of Promacta/Revolade (eltrombopag) in combination with azacitidine (the current standard of care) versus placebo in combination with azacitidine in intermediate-1, intermediate-2 or high risk patients with MyeloDysplastic Syndromes (MDS) with 1 or more Cytopenias. The global study will assess the proportion of patients who are platelet transfusion free during the first four cycles of treatment. Approximately 350 patients across 30 countries and 156 study sites with intermediate-1, intermediate-2 or high risk MDS (by International Prognostic Scoring System) will be enrolled in the study.

Eligible patients will be randomised to receive either eltrombopag (200 mg once daily [100 mg for East Asians]) plus azacitidine (75 mg/m2 subcutaneously once daily for 7 days) every 28 days, for at least 6 cycles, or placebo plus azacitidine. Dose modifications of eltrombopag or placebo will be permitted to ensure that patient platelet counts remain at a safe and effective level. The primary efficacy endpoint will determine the platelet supportive care effects of the treatment. Secondary objectives will compare factors including overall survival, disease response and haematologic improvement.