Novartis Reports Positive Phase III Trial Data for Ianalumab in Immune Thrombocytopenia
The Ianalumab and Eltrombopag combination extended the duration of disease control by 2.8 times, with no new safety signals reported.
Novartis has announced favorable outcomes from the Phase III clinical trial VAYHIT2, which assessed the efficacy of ianalumab combined with eltrombopag for treating patients with primary immune thrombocytopenia (ITP) who had received prior corticosteroid treatment.
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Disease Control Efficacy:
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The trial results indicated that four once-monthly doses of ianalumab (9mg/kg), plus eltrombopag, extended disease control by 45%, based on the Time to Treatment Failure (TTF), compared to placebo plus eltrombopag.
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The median TTF for the ianalumab plus eltrombopag group was 13.0 months, which is 2.8 times longerthan the 4.7 months observed in the placebo group.
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Secondary Endpoint: At six months, 62% of patients receiving ianalumab at the 9mg/kg dose achieved sustained improvements in platelet counts, compared to 39% in the placebo group, thereby meeting the key secondary endpoint.
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Quality of Life Improvement: Patients in the ianalumab group reported a mean reduction in fatigue of 7.7 points on the PROMIS Fatigue scale, compared to a 3.6-point reduction among those receiving placebo.
Dual Mechanism of Action and Safety Profile
Novartis global head of oncology development, Mark Rutstein, explained that ITP results from an autoimmune response driven by B cells, leading to platelet destruction. The novel dual mechanism of action of ianalumab aims to deplete B cells while simultaneously blocking their survival signals.
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Dosing: VAYHIT2 tested two ianalumab doses. The 9mg/kg dose demonstrated statistically significant improvements in both the primary and key secondary endpoints, while the 3mg/kg dose achieved significant improvement in the primary endpoint.
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Safety Profile: Ianalumab was observed to be well tolerated, and no new safety signals were reported. The most common adverse events were infusion-related reactions and headache. Neutropenia was noted more frequently with ianalumab but resolved without intervention.
VAYHIT2 marks the third positive Phase III study for ianalumab, following previous trials in adults with active Sjögren’s disease. Novartis plans to submit the data from VAYHIT2, alongside results from the ongoing first-line ITP trial (VAYHIT1), in 2027.
