Benefit of Adding Ibrutinib to Bendamustine Rituximab (B-R) in Frontline Mantle Cell Lymphoma: First Phase III Trial Changing the Paradigm in the Management of Elderly Patients
June 03, 2022
John Theurer Cancer Center Investigators Participate in Large Pivotal International Study
Hackensack Meridian John Theurer Cancer Center investigators participated in the large phase III multicenter SHINE study, which reported that using the drug ibrutinib (Imbruvica®) in combination with standard therapy B-R as initial treatment for mantle cell lymphoma (MCL) slowed the disease growth by 52% in older people who were newly diagnosed with the disease. The treatment could become the new standard of care for older people with mantle cell lymphoma, who may not be able to tolerate more intensive treatment regimens. The study was published in the New England Journal of Medicine on June 3, 2022.
"The field of mantle cell lymphoma continues to evolve: the SOC in elderly patients (i.e. over half of the mantle cell lymphoma population at diagnosis) not eligible for high dose therapy upfront - has been chemoimmunotherapy most frequently BR, though most patients relapse over time,” explained Andre Goy, M.D., M.S., chairman and executive director of John Theurer Cancer Center, who led the center's participation in the SHINE study. “Ibrutinib was the 1st BTK inhibitor approved in MCL and has been a game changer in the r/r setting in MCL. Logically, the next step was to bring it in the frontline setting, which was the subject of the SHINE trial - which dramatically improved outcome - with after a median follow-up of 7 years, a PFS of 6.7 years in the BR+ ibrutinib arm versus 4.4 years for BR + placebo arm. This is highly significant and could easily translate into becoming the next standard of care”
In this study, mantle cell lymphoma patients 65 years and olde, and untreated, were randomly assigned to receive six cycles of bendamustine and rituximab with either ibrutinib (261 patients) or a placebo (262 patients). Patients who responded to treatment received up to 12 additional doses of rituximab as maintenance therapy. Researchers compared progression-free survival (PFS, the time it took for the cancer to continue growing) between the two groups.