Novartis ianalumab Phase III trial meets primary endpoint in ITP

Novartis (NVS) announced positive top-line results from VAYHIT2, a Phase III trial evaluating ianalumab plus eltrombopag in patients with primary immune thrombocytopenia, ITP, previously treated with corticosteroids. Ianalumab plus eltrombopag, compared to placebo plus eltrombopag, significantly prolonged the time to treatment failure, TTF,, the primary endpoint that assesses how long patients maintain safe platelet levels during and after the treatment period. Ianalumab is being investigated in other B cell-driven autoimmune diseases, including ongoing Phase III trials in first-line ITP and in second and later lines of warm autoimmune hemolytic anemia, with readouts expected in 2026. In VAYHIT2, patients treated with ianalumab plus eltrombopag experienced a significantly higher rate of sustained improvements in platelet count at six months, the key secondary endpoint of the study. The safety profile of ianalumab was consistent with what was previously observed in clinical studies, with no new safety signals. Data is expected to be presented at an upcoming medical meeting and included in future regulatory submissions in 2027 along with results from the ongoing first-line ITP trial, VAYHIT1.