Core Insights - Novartis announced positive results from the VAYHIT2 Phase III trial, showing that ianalumab plus eltrombopag significantly improved disease control in patients with primary immune thrombocytopenia (ITP) compared to placebo [1][6][8] Group 1: Trial Results - Ianalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45%, with a median time to treatment failure of 13.0 months compared to 4.7 months for placebo plus eltrombopag [1][6] - 62% of patients receiving ianalumab plus eltrombopag achieved sustained platelet count improvement at six months, compared to 39% for placebo plus eltrombopag [3][5] - The trial demonstrated a mean reduction in fatigue of 7.7 points with ianalumab plus eltrombopag versus 3.6 points with placebo plus eltrombopag [3] Group 2: Mechanism and Administration - Ianalumab targets B cells through a dual mechanism, depleting B cells while blocking survival signals, which is crucial for managing ITP [4][9] - The treatment regimen consists of four once-monthly intravenous doses, potentially reducing the need for chronic therapy [6][8] Group 3: Safety and Tolerability - Ianalumab was well tolerated, with adverse events comparable to placebo, the most common being headache and infusion-related reactions [7] - Neutropenia occurred more frequently in the ianalumab groups but most cases resolved without treatment [7] Group 4: Future Plans - Novartis plans to submit VAYHIT2 data along with results from the ongoing first-line ITP trial, VAYHIT1, to health authorities in 2027 [6][8]