iNNOVATE™: Infusion-related Reactions and Discontinuation or Dose Reduction Due to ARs1-3


Final Analysis (median follow-up of 50 months)1


iNNOVATE™: IgM Flare Incidence Rate2,3


At primary analysis (median follow-up of 26.5 months)3

  • IgM flare was defined as initial transient increase in serum IgM levels commonly associated with rituximab treatment that did not indicate disease progression2
  • Incidence of IgM flare was not a study endpoint; however, laboratory serum IgM levels were collected during study conduct to allow for the assessment and management of IgM flare by study investigators2

IgM=immunoglobulin M.

References: 1Buske C, Tedeschi A, Trotman J, et al. Ibrutinib plus rituximab versus placebo plus rituximab for Waldenström's macroglobulinemia: final analysis from the randomized phase III iNNOVATE study. J Clin Oncol. 2022;40(1):52-62. doi:10.1200/JCO.21.00838  2Data on file. 3Dimopoulos MA, Tedeschi A, Trotman J, et al. Phase 3 trial of ibrutinib plus rituximab in Waldenstrom's macroglobulinemia. N Engl J Med. 2018;378(25):2399-2410.