iNNOVATE™: Prespecified secondary endpoint, IMBRUVICA® + rituximab vs rituximab

IMBRUVICA® + rituximab vs rituximab1-3

These data are not included in the Prescribing Information for IMBRUVICA®​​

  • Long-term data from the final analysis, with overall follow-up of 63 months; median follow-up was 50 months1,2

Overall Survival

Median overall survival was not reached for either treatment arm. With an overall follow-up of 63 months, 47% of patients randomized to the placebo + rituximab arm crossed over to receive IMBRUVICA®, 9 (12%) patients on IMBRUVICA® + rituximab and 10 (13.3%) patients on placebo + rituximab had died.1

  • Crossover was allowed in the study, at least one minimum criteria per the IWWM-2 is required for a patient to be eligible for next-line IMBRUVICA® treatment who had IRC-confirmed disease progression or symptomatic disease3

CI=confidence interval, HR=hazard ratio, IWWM=International Workshop on Waldenstrom's Macroglobulinemia, NE=not evaluable, RR=response rate, TTNT=time to next treatment, WM=Waldenström's macroglobulinemia.

References: 1IMBRUVICA® (ibrutinib) Prescribing Information. 2Buske 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 3Data on file.