Charles Gaulin: Safety of ibrutinib in previously untreated high-risk smoldering mantle cell lymphoma

Charles Gaulin, Lymphoma/Myeloma Fellow at MD Anderson Cancer Center, shared on LinkedIn:

“At ASH23, we presented results from our phase II study evaluating the efficacy and safety of ibrutinib in 20 patients with previously untreated high-risk smoldering mantle cell lymphoma. All evaluable patients (n=18) responded to therapy, with 93.3% (n=14/15) of patients achieving a PET CR. Eight patients discontinued therapy, mostly due to adverse events (n=5/8), with only one patient experiencing disease progression while on therapy. After a median follow-up of 25 months, median PFS and DOR were not reached. No deaths occured in the study population.

Ibrutinib demonstrated significant efficacy with manageable toxicities in previously untreated patients with high-risk smoldering MCL. These results compare favorably to the reported median PFS time of about 18 months under a watch and wait approach. These results also compare favorably to ibrutinib + rituximab (Giné E et al., J Clin Oncol, 2022) in a similar population calling into question the added benefit of an anti-CD20 monoclonal antibody in these indolent patients. Additional follow-up is needed to confirm these findings. Future studies using second generation BTKi are also underway (ZEBRA – NCT05635162).”

Source: Charles Gaulin/LinkedIn