Novartis announces results from Phase III VAYHIT2 trial

Novartis (NVS) announced positive results from VAYHIT2, a Phase III trial evaluating ianalumab plus eltrombopag in patients with primary immune thrombocytopenia previously treated with corticosteroids. Ianalumab plus eltrombopag extended ITP disease control by 45%, based on the primary endpoint of time to treatment failure, which assesses how long patients maintain safe platelet levels during and after the treatment period. The median time to treatment failure for patients receiving ianalumab plus eltrombopag was 2.8 times longer than those on placebo plus eltrombopag. Patients receiving ianalumab plus eltrombopag also achieved a significantly higher rate of sustained platelet count improvement at six months versus placebo plus eltrombopag, meeting the key secondary endpoint. Fatigue improvement, as measured by PROMIS Fatigue, showed a mean reduction of 7.7 points with ianalumab plus eltrombopag versus 3.6 points with placebo plus eltrombopag.