The Bruton’s tyrosine kinase inhibitor (BTKi) ibrutinib has emerged as possibly the most effective and well-tolerated of the novel agents in the management of relapsed and refractory (r/r) mantle cell lymphoma (MCL). Pooled 7.5-year survival data from clinical trials show five-year progression-free (PFS) and overall survival (OS) of 19% and 41%, respectively. However, until now, long-term data to compare real-world with clinical trial outcomes has been lacking.
Published in the British Journal of Haematology this week is a five-year real-world observational study of survival and tolerability of ibrutinib monotherapy in 65 patients with r/r MCL at 37 hospitals across the UK and Ireland as part of the Janssen-Cilag Named Patient Programme (NPP) which ran from November 2014 to December 2015.
The median progression-free survival (PFS) and overall survival (OS) was found to be 12 and 18.5 months, respectively. Ibrutinib was well-tolerated with no fatal adverse events.
Overall, 80% of patients discontinued treatment, predominantly due to disease progression. On discontinuation, 20% received alternative immunochemotherapy with a median OS of 24 months.
Ibrutinib was used as a bridge to transplant in 8% (median OS not reached).
The observations are comparable with trial outcomes, with encouraging responses to immunochemotherapy at relapse.