Phase III trial of Promacta/Revolade meets primary endpoint in Thrombocytopenic Purpura - GSK

GlaxoSmithKline has announced the results from the Phase III PETIT2 study evaluating the efficacy of Promacta/Revolade (eltrombopag) in paediatric patients with chronic immune (idiopathic) Thrombocytopenic Purpura (cITP). The drug met its primary endpoint, achieving a statistically significant improvement in platelet counts with almost 40 percent of patients treated with eltrombopag attaining a consistent platelet response for 6 of 8 weeks compared to placebo (39.7 percent vs. 3.4 percent, respectively).

Efficacy results for PETIT2 were consistent across age cohorts. The safety profile was consistent with the established profile for eltrombopag and no new safety concerns were observed. The most common adverse events occurring most frequently in the eltrombopag arm included nasopharyngitis, rhinitis, cough and respiratory tract infection. Data were presented at the European Haematology Association Annual Congress.