ASH 2021 | BRUIN MCL-321: Pirtobrutinib in BTKi naïve MCL
Nirav Niranjan Shah, MD, Medical College of Wisconsin, Milwaukee, WI, provides an overview of the trial design and rationale of the randomized, open-label Phase III trial (NCT04662255) of pirtobrutinib, a non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, in patients with relapsed mantle cell lymphoma (MCL). Initial clinical data has shown pirtobrutinib to be as efficacious and safe as existing BTK inhibitors with fewer adverse events including neutropenia, and atrial fibrillation. In this trial, BTK inhibitor naïve patients will either receive pirtobrutinib, or existing BTK inhibitors including ibrutinib, acalabrutinib, or zanubrutinib. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.
Transcript (edited for clarity)
Pirtobrutinib is a non-covalent BTK inhibitor, which in the original BRUIN study published in Lancet earlier this year really showed tremendous potential for efficacy and safety. In terms of efficacy, it worked specifically in patients who were prior BTK exposed and from a safety standpoint, didn’t show the same toxicity profile we see with other BTK inhibitors. So we didn’t see as much atrial fibrillation, neutropenia or bleeding or bruising events...
Pirtobrutinib is a non-covalent BTK inhibitor, which in the original BRUIN study published in Lancet earlier this year really showed tremendous potential for efficacy and safety. In terms of efficacy, it worked specifically in patients who were prior BTK exposed and from a safety standpoint, didn’t show the same toxicity profile we see with other BTK inhibitors. So we didn’t see as much atrial fibrillation, neutropenia or bleeding or bruising events. So given that early phase data has shown promise, even in a BTK pretreated population, there’s been development of a new study to basically compare this head to head to current covalent BTK inhibitors. So the BRUIN MCL Phase III clinical trial is going to take any patients with relapsed mantle cell that are BTK naive and patients will be randomized to investigators’ choice so they can choose between the approved BTK inhibitor.
They can give zanubrutinib, acalabrutinib or ibrutinib as a standard of care option and then the other half of patients will be randomized to pirtobrutinib. This is exactly the kind of study we want to see done rather than comparing pirtobrutinib to historical controls where we know pirtobrutinib would be better. This is really comparing it to the current standard of care and so I think it’s a very exciting trial to be a part of and I’m glad that the sponsors of the company have designed it to really give us a signal as to how this compares to the current standard of care with the covalent BTK inhibitors.
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