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ASH 2025 | The LUNA4 study: rilzabrutinib in patients with primary ITP after first-line treatment failure
David Kuter, MD, Massachusetts General Hospital, Boston, MA, discusses the LUNA4 study (NCT07007962), a Phase IIIb trial investigating the use of rilzabrutinib, a BTK inhibitor, in patients with primary immune thrombocytopenia (ITP) after first-line treatment failure. The goal of the study is to improve platelet count and quality of life, and to potentially alter the disease trajectory through early intervention. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
ITP is a common hemolytic disorder characterized by low platelet count, bleeding, but what many patients don’t understand and many doctors don’t understand is there’s an equally important component of fatigue and other events that happen that are probably inflammatory in nature. Rilzabrutinib is a BTK inhibitor. It inhibits Bruton’s kinase. And Bruton’s kinase is necessary for macrophage function...
ITP is a common hemolytic disorder characterized by low platelet count, bleeding, but what many patients don’t understand and many doctors don’t understand is there’s an equally important component of fatigue and other events that happen that are probably inflammatory in nature. Rilzabrutinib is a BTK inhibitor. It inhibits Bruton’s kinase. And Bruton’s kinase is necessary for macrophage function. It’s necessary for B-cell activation. It also contributes to a whole bunch of inflammatory markers. By inhibiting BTK with this oral medication, we can make the B-cells make less antibody against platelets potentially. We know that it decreases macrophage destruction of platelets. We also know it decreases the inflammasome by decreasing a whole bunch of cytokines. We’ve studied this in phase three studies, presented these meetings last year, the LUNA3 study. And in that study, we showed that patients who got this medication with bad ITP, ITP sometimes for over eight years in duration, having failed more than four prior therapies, had response rates of 23 percent which is a durable response, but overall the response rate was 60 percent having a plate count rise over 50,000. This drug is now approved in North America for treating ITP; that approval occurred by the FDA some two or three months ago and it’s now widely used. The problem, and if I can say so, with that study, is it looked at patients with late-stage disease. We are eager to know whether the similar effect might be even more beneficial when given early. So, LUNA4 is a study to look at early administration of rilzabrutinib, a BTK inhibitor, in patients with ITP who have been given steroids, for example, for three to four months, and then have a choice of other therapies, in this situation, they’ll be randomized to other forms of therapy or rilzabrutinib. And our goal is to see if we can not only make the plate count rise, make the patient’s quality of life better, but furthermore, by decreasing the trajectory of these early patients such that they don’t become chronic ITP patients. This study is currently enrolling patients globally and we hope to have the data perhaps by this meeting next year.
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