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New Protocol: Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma

New Protocol: Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma
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 Jun 30;386(26):2482-2494.

Wang, Michael L et al. “Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma.”

https://doi.org/10.1056/nejmoa2201817

Reviewed by Hasan Çağrı Yıldırım, MD on Jul 05, 2022

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