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Mantle cell lymphoma (MCL) is a rare type of non-Hodgkin lymphoma that results due to the neoplastic transformation of B lymphocytes.1 Bruton’s tyrosine kinase (BTK) is a key component in B lymphocyte signalling pathways, thus BTK inhibitors are pharmaceutically exploited for the treatment of patients with relapsed/refractory (R/R) MCL.2 However, some, such as ibrutinib, are associated with significant side effects that require careful management.2 Second-generation BTK inhibitors, like tirabrutinib (GS/ONO-4059) have greater selectivity and seek to overcome the off-target effects seen with their predecessors. Tirabrutinib has demonstrated preliminary activity and was well tolerated in a phase I study in the R/R B-cell malignancy setting and in a 3-year follow-up of patients with chronic lymphocytic leukemia.3,4 In a letter to the editor recently published in Leukemia, Simon Rule, Plymouth University, Plymouth, UK, and colleagues, presented the 3-year follow-up data from a phase I extension study (NCT02457559) of tirabrutinib treatment in patients with MCL.5
Table 1. Most common grade ≥3 AEs
AE |
% |
Thrombocytopenia |
19 |
Anemia |
13 |
Dyspnea |
13 |
Lower respiratory tract infection |
6 |
Maculopapular rash |
6 |
Upper respiratory tract infection |
6 |
No tirabrutinib discontinuations as a result of AEs were observed in this long-term follow-up study in contrast with similar studies using ibrutinib in R/R MCL (median follow-up 26.7 months), where 11% of patients had discontinued ibrutinib due to AEs. Off-target effects, such as atrial fibrillation and grade 3 or higher bleeding events and headache were absent or markedly less frequent in this study compared to phase II studies of other second generation BTK inhibitors (acalabrutinib). The results of this study support persistent, robust efficacy and safety of tirabrutinib even after multiple lines of therapy in the R/R MCL setting.
References
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Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?