EHA 2023 | Updates from the BRUIN study – long-term safety of pirtobrutinib in R/R MCL
Wojciech Jurczak, MD, PhD, Jagiellonian University, Krakow, Poland shares updates from the BRUIN Phase I/II trial (NCT03740529) investigating the non-covalent third-generation Bruton’s tyrosine kinase (BTK) inhibitor pirtobrutinib in the treatment of relapsed/refractory (R/R) B-cell malignancies including mantle cell lymphoma. Pirtobrutinib was well-tolerated in terms of hematological toxicity and infections, and the adverse event rate was lower than that seen for second-generation BTK inhibitors. Prof. Jurczak also briefly discusses other trials investigating BTK inhibitors including zanubrutinib and acalabrutinib. This interview took place at the 28th Congress of the European Hematology Association (EHA) 2023 in Frankfurt, Germany.
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Transcript (edited for clarity)
The BRUIN study of pirtobrutinib – the pirtobrutinib study – that’s, well, we call it an (inaudible) Phase I study on steroids, I think we entered nearly 1,000 patients there. However, talking about mantle cell lymphoma, that’s a very interesting perspective. There were a couple of abstracts we presented, and first, the abstract summarizing the long-lasting effects and responses which were very very appealing, mind you, out of over 90 patients analyzed, 90% of them were previously treated with BTKs, so they were either BTK-intolerant of BTK-failers...
The BRUIN study of pirtobrutinib – the pirtobrutinib study – that’s, well, we call it an (inaudible) Phase I study on steroids, I think we entered nearly 1,000 patients there. However, talking about mantle cell lymphoma, that’s a very interesting perspective. There were a couple of abstracts we presented, and first, the abstract summarizing the long-lasting effects and responses which were very very appealing, mind you, out of over 90 patients analyzed, 90% of them were previously treated with BTKs, so they were either BTK-intolerant of BTK-failers.
Talking BTK-intolerant, the pirtobrutinib is one of the most favorable toxicity issues – CTCA grade three or higher events are a rarity, the drug is very well tolerated both in terms of hematologic toxicity and infections. This should be of notice because the adverse event rate is uncomparable with other non-covalent third-generation BTK inhibitors, pretty smaller than the known second-generation BTK inhibitors. In this meeting we also presented the longer data of zanubrutinib toxicity based on over 1,500 patients, and again, it’s a very well tolerated second-generation.
But talking about mantle cell lymphoma, of pirtobrutinib we had relapsing/refractory mantle cell lymphoma, refractory to second-generation BTK inhibitors. But we had other BTK inhibitor abstracts in mantle cell lymphoma. First, the BR + acalabrutinib both in the first line and relapsing/refractory setting, with very reasonable results, which may be more important at the time where FDA did not prolong the approval of ibrutinib in relapsing/refractory mantle cell lymphoma.
The other couple of presentations, which are not ours but should be noted, are zanubrutinib with rituximab in the first line, and again zanubrutinib seem to have even a higher activity resulting in over 90% of complete regressions.
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