Sanofi Announced Rilzabrutinib Demonstrated Significant Patient Benefit In First Positive Phase 3 Study Of BTK Inhibitor In ITP At ASH; Said Phase 3 Data Show Rapid And Durable Platelet Response, Reduced Bleeding And Need For Rescue Response

Benzinga · Dec 8 04:38

Positive results from the pivotal LUNA 3 phase 3 study of rilzabrutinib in adults with persistent or chronic immune thrombocytopenia (ITP), a rare immune-mediated disease, reinforce the efficacy and safety of rilzabrutinib, an oral, reversible, covalent Bruton's tyrosine kinase (BTK) inhibitor, and further support its potential as a first-in-class treatment for ITP. Platelet response was achieved in 65% (n=86) of patients receiving rilzabrutinib compared to 33% (n=23) of patients on placebo. The primary endpoint was met, with rilzabrutinib demonstrating durable platelet response in 23% of ITP adult patients compared to 0% on the placebo arm (p<0.0001), as well as key secondary endpoints including reduced bleeding, number of weeks with platelet response, the need for rescue therapy use, and improved physical fatigue and quality of life measures.

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Sanofi Announced Rilzabrutinib Demonstrated Significant Patient Benefit In First Positive Phase 3 Study Of BTK Inhibitor In ITP At ASH; Said Phase 3 Data Show Rapid And Durable Platelet Response, Reduced Bleeding And Need For Rescue Response

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