Author: Editorial Staff 09 May 2024
Patients treated with the drug achieved a durable platelet response compared to those receiving placebo
Milano – I am the results of the Phase III LUNA 3 study are positive who have demonstrated the ability to rilzabrutinib (administered in a dosage of 400 mg twice daily orally) to reach the primary endpoint of the trial, represented by Durable platelet response in adult patients with immune thrombocytopenia (ITP) persistent a chronic. The safety profile of rilzabrutinib was consistent with that reported in previous studies.
The LUNA 3 study met its primary endpoint demonstrating that a significantly greater proportion of patients treated with rilzabrutinib achieved a durable platelet response compared to those treated with placebo. This clinically and statistically significant result was obtained in a population of patients with primary ITP refractory to previous therapies. Overall, patients enrolled in the study had an average of four prior therapies for ITP and a median baseline platelet count of 15,000/microliter (physiologic platelet count levels typically range from 150,000 to 450,000/microliter). The positive results on key secondary endpoints also highlight the potential of rilzabrutinib to provide clinically significant benefits to patients with persistent and chronic ITP.
Immune thrombocytopenia (ITP) is a serious acquired autoimmune hematological disorder, characterized by the destruction of platelets mediated by autoantibodies and impaired platelet production, causing thrombocytopenia (i.e. with a platelet count less than 100,000/microliter) and an increased risk of potentially lethal bleeding episodes (such as intracranial hemorrhage ). Furthermore, patients diagnosed with ITP often suffer from conditions such as fatigue and cognitive dysfunction that limit their quality of life.
Thanks to its dual mechanism of action, which reduces the production of pathogenic autoantibodies and decreases platelet destruction mediated by macrophages, the Bruton’s tyrosine kinase inhibitor rilzabrutinib has the potential to address the underlying mechanisms responsible for a wide range of ITP complications.
LUNA 3 is a randomized, multicenter Phase III study which evaluates the efficacy and safety of rilzabrutinib compared to placebo in adult and adolescent patients with persistent or chronic ITP. Patients were treated with rilzabrutinib 400 mg orally twice daily or placebo for a 12- to 24-week double-blind treatment period, followed by a 28-week open-label treatment and follow-up period safety or long-term extension of 4 weeks. For the study arm evaluating adolescents, patient recruitment is still ongoing. The detailed results of the Phase III LUNA 3 study will be presented during 2024 at the main scientific conferences.