On 22nd May 2018, a paper was published in The British Journal of Haematology on the four year follow up of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) treated with ibrutinib and rituximab (IR). The paper was authored by Preetesh Jain, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, and colleagues.
- The study was a phase II open-label, single-center trial including 50 patients. The median age of patients was 68 years (range, 45–85). 76% were male
- Median follow-up was 47 months (range, 1–52)
- The objective response rate (ORR) was 88%
- 58% achieved CR
- Median event-free survival (EFS) was 16 months
- Median duration of response (DOR) was 46 months
- Median PFS was 43 months
- Median OS was not reached
- 76% of patients discontinued treatment
- The most frequent grade ≥3 adverse events (AEs) included; infection (n = 14), atrial fibrillation (n = 6) and pain (n = 6)
- 18 patients died due to progressive disease (n = 14) and other causes (n = 4)
The authors concluded that in this four-year follow-up study, the combination of IR was “efficacious without long-term toxicities”. In addition, IR caused durable remissions that could improve survival.
Jain P. et al. Four-year follow-up of a single arm, phase II clinical trial of ibrutinib with rituximab (IR) in patients with relapsed/refractory mantle cell lymphoma (MCL). The British Journal of Haematology. 2018 May 22. doi: 10.1111/bjh.15411. [Epub ahead of print]