* Results from the final analysis of the randomized arms of the phase III iNNOVATETM study. 150 patients (treatment-naive or previously treated) with confirmed symptomatic WM requiring treatment were randomised to once-daily IMBRUVICA® or rituximab + placebo. Median treatment duration for IR was 48 months.1
† Median OS was not reached in either treatment arm; at the 54 month landmark timepoint, the OS rate was 86% with IMBRUVICA® + rituximab [regardless of number of prior therapies (1-2 vs ≥3)] vs. 84% with rituximab + placebo.1
‡ Median PFS was not reached with IMBRUVICA® + rituximab (95% CI: 57.7 months to not estimable).1
§ Results from the final analysis of the iNNOVATETM open-label substudy. 31 patients with WM who failed to achieve at least a minor response or who relapsed <12 months after their last rituximab-containing therapy received IMBRUVICA®.2
II 22 patients (71%) had sustained improvement in Hgb, including 17/21 (81%) with baseline Hgb ≤110 g/L.2
IMBRUVICA® as a single agent is indicated for the treatment of adult patients with Waldenström’s Macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. IMBRUVICA® in combination with rituximab is indicated for the treatment of adult patients with WM.3
1. Buske C et al. Five-Year Follow-Up of Ibrutinib Plus Rituximab (IR) Vs Placebo Plus Rituximab for WM: Final Analysis From the Randomized Phase 3 iNNOVATETM Study. Oral and Poster Abstracts presented at ASH Annual Meeting % Exposition; 508 December 2020; all-virtual. #623
2. Trotman J et al. Long-Term Follow-up of Ibrutinib Treatment for Rituximab-Refractory WM: Final Analysis of the Open-Label Substudy of the Phase 3 iNNOVATETM Trial. Oral and Poster Abstracts presented at 62nd ASH Annual Meeting & Exposition; 5-8 December 2020; all-virtual. #623
3. IMBRUVICA® Summary of Product Characteristics. Janssen-Cilag International NV. 2020.
4. Buske C et al. Ibrutinib treatment in Waldenström’s macroglobulinaemia : follow-up efficacy and safety from the iNNOVATE™ study. Oral presentation at the 60th ASH Annual Meeting and Exposition; 1–4 December 2018; San Diego, CA, USA.
5. Treon SP et al. J Clin Oncol 2020; Epub ahead of print.
6. Kastritis E et al. Ann Oncol 2018;29(Suppl 4):iv41–iv50.
7. Byrd JC et al. Clin Cancer Res 2020; 26(15): 3918–3927.
8. Janssen Data on File. Ibrutinib – global number of cumulative patients treated with Ibrutinib since launch. EMEA-SR-1492. July 2020.
9. Burger JA et al. Outcomes of 1L Ibrutinib in Patients with CLL/SLL and High-Risk Genomic Features with up to 6.5 Years Follow-up: Integrated Analysis of Two Phase 3 Studies (RESONATE-2 and iLLUMINATE). Oral and Poster Abstracts presented at 62nd ASH Annual Meeting & Exposition; 5-8 December 2020; all-virtual. #642.
10. Rule S et al. Long-term outcomes with ibrutinib versus the prior regimen: a pooled analysis in relapsed/refractory (R/R) mantle cell lymphoma (mcl) with up to 7.5 years of extended follow-up. Poster presented at the 61st ASH Annual Meeting & Exposition; 7−10 December 2019; Orange County Convention Center(OCCC), Orlando, FL, USA.