In a multicenter phase I and II clinical trial, MCW Cancer Center’s Nirav Shah, MD, joined investigators from across the globe to test the Bruton tyrosine kinase inhibitor (BTKi), Pirtobrutinib, in patients previously treated for mantle cell lymphoma (MCL). Results of the study showed that Pirtobrutinib was both safe and effective, leading to accelerated approval by the Food and Drug Administration earlier this year. The findings were published in the .
“This trial builds on years of research to identify a safe and effective way to extend longevity for patients with MCL who have not responded to other forms of treatment.”
In the study, sponsored by Loxo Oncology, Inc., the team evaluated a cohort of 90 patients between 46 and 87 years of age who had been treated with a median of three prior lines of therapy. More than half (57.8%) experienced a positive response to Pirtobrutinib, extending their lives by nearly two years.
MCL is an aggressive, rare subtype of B-cell non-Hodgkin lymphoma. Patients with relapsed/refractory MCL historically experience survival rates of less than 10 months, and drug resistance or intolerance to covalent BTKi therapy is common. Pirtobrutinib is the first BTKi of any kind to demonstrate and extended response in patients with relapsed/refractory MCL previously treated with a covalent BTKi therapy.
“We now look forward to seeing the that will evaluate the role of Pirtobrutinib as a second-line treatment option for patients with relapsed/refractory MCL,” said Dr. Shah.