Photo Credit: Md Ariful Islam
In the phase 3 LUNA 3 trial, rilzabrutinib, compared with placebo, improved efficacy and QOL outcomes with an accompanying favorable safety profile among heavily pre-treated adult patients with immune thrombocytopenia (ITP).
The phase 3 LUNA 3 trial (NCT04562766) randomly assigned 202 adult patients with previously treated ITP 2:1 to the BTK inhibitor rilzabrutinib twice daily or a placebo1. “Participants had qualifying platelet counts <30×109/L and were allowed stable concomitant corticosteroids and/or TPO receptor agonists,” said David Kuter, MD, from the Massachusetts General Hospital. The primary endpoint was a durable response at week 25, defined as a platelet count greater than or equal to 50×109/L for more than two-thirds of the last 12 weekly visits without rescue therapy.
The primary endpoint was achieved by 23% of the participants on rilzabrutinib and by 0% of those on placebo (Δ23%; 95% CI 16–30%; P<0.0001). Secondary endpoints, such as the use of rescue therapy, bleeding score, and fatigue, also significantly favored rilzabrutinib over placebo. Dr. Kuter expressed that the safety profile of rilzabrutinib was better than that of other BTK inhibitors. “We observed two important rilzabrutinib-related AEs: a grade 4 neutropenia and a grade 3 peripheral embolism.” Otherwise, AEs were mostly of grade 1 or 2 and there was no documented BTK class effect.
“Rilzabrutinib was associated with quick and durable platelet responses, improved QOL outcomes, and was well-tolerated in a heavily pre-treated population of patients with ITP,” concluded Dr. Kuter.
Medical writing support was provided by Robert van den Heuvel.
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