This trial was launched with two questions in mind. First was whether the fixed duration combination of a BTK inhibitor with a CD20 monoclonal antibody therapy without a BCL2 inhibitor can give a prolonged duration of treatment and also deepen response. The second question of this trial was to assess the cardiac safety of the pirtobrutinib during the monotherapy phase in more detail. So what we did, we launched an investigative response study, accrued 60 patients in the initial cohort, and currently reporting the findings after the median follow-up of 14 months...
This trial was launched with two questions in mind. First was whether the fixed duration combination of a BTK inhibitor with a CD20 monoclonal antibody therapy without a BCL2 inhibitor can give a prolonged duration of treatment and also deepen response. The second question of this trial was to assess the cardiac safety of the pirtobrutinib during the monotherapy phase in more detail. So what we did, we launched an investigative response study, accrued 60 patients in the initial cohort, and currently reporting the findings after the median follow-up of 14 months. So far, the response rate to the end of therapy response assessment was 79%. The depth of response measured by flow cytometry was 38% with the undetectable MRD at the end of therapy. In terms of the cardiac safety, we did not observe any structural or functional changes to the heart. The rate of atrial fibrillation was very low, occurred in one patient with a remote history of prior atrial fibrillation. The rate of hypertension was also low at 10%. So overall, very well-tolerated low rates of cardiovascular events on the study. In terms of the efficacy, I think it’s a little bit early to give a strong conclusion about the study, although it looks promising and we have about a year of follow-up after finishing the last dose of the treatment.
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