Study
| International, randomized, double-blind, phase 3 trial (SHINE) |
| 65 years of age or older mantle cell lymphoma Untreated, stage II to IV disease |
| Ibrutinib (N:261) or placebo (N:262), bendamustine and rituximab (induction treatment) |
| Patients with an objective response continued to receive ibrutinib or placebo, plus rituximab |
Efficacy
| mPFS:80.6 m vs 52.9 m (HR: 0.75; 95% CL, 0.59-0.96; P=0.01) |
| CR: 65.5% vs 57.6% (P=0.06 |
Safety
| Grade >= 3 AEs: 81.5% vs 77.3% |
| Grade >=3 AEs; neutropenia 47.1% vs 48.1%, pneumonia 20.1% vs 14.2%, lymphopenia 16.2% vs 11.9%, anemia 15.4% vs 8.8%, thrombocytopenia 12.7% vs 13.1%, rash 12.0% vs 1.9%, leukopenia 10.0% vs 11.2% |
N Engl J Med 2022; 386:2482-2494
Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma
http://doi.org/10.1056/NEJMoa2201817
Reviewed by Hasan Cagri Yildirim, MD on Sep 20, 2022
