Addition of Bruton’s tyrosine kinase inhibitor ibrutinib to chemoimmunotherapy prolonged progression-free survival (PFS) in patients with untreated mantle cell lymphoma (MCL). The findings of this randomized clinical study were recently published in the New England Journal of Medicine.
Patients with mantle cell lymphoma are often very old, and their inclusion in clinical studies can help design beneficial and tolerable treatment regimens. Towards this, the SHINE trial has investigated the efficacy and safety of adding ibrutinib to the standard of care for MCL patients.
The randomized phase III SHINE trial enrolled 523 MCL patients (65 years or more) from 183 sites across all geographical locations. All the patients were randomly (1:1) administered ibrutinib (560 mg) or placebo plus six cycles of bendamustine and rituximab. The patients with the objective response received rituximab maintenance therapy every 8 weeks up to 12 additional doses. The study’s primary endpoint was PFS in addition to safety and overall survival.
After a median follow-up of 84.0 months, patients in the ibrutinib had a longer PFS of 80.6 months as compared to the placebo group (52.9 months; HR, 0.75; 95% CI, 0.59-0.96; P=0.01). However, the overall survival rates were quite similar between both the groups (55% ibrutinib vs. 56.8% in control group; HR, 1.07; 95% CI, 0.81-1.40).
According to Michael Wang, MD, of MD Anderson Cancer Centre in Houston, “The SHINE study is the first international phase III trial to show a positive impact of ibrutinib combined with standard-of-care treatment in this disease. The progression-free survival is substantially longer than the common treatment options used today, which is an important clinical advancement.”