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IMBRUVICA® IN Waldenström’s MacroglobulinAemia (WM): experience you can rely on1,2

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COUNT ON SUPERIOR EFFICACY

vs. rituximab alone, regardless of prior treatment status, genotype and patient characteristics (n=150)1*

Median progression-free survival (PFS)

Not reached vs 20.3 months

IMBRUVICA® + rituximab vs. rituximab + placebo (HR:0.250; P<0.0001)

2 out of 3 patients were alive and progression free at 54 months

68% IMBRUVICA® + rituximab vs.

25% rituximab + placebo (P<0.001)

Overall survival: 8 out of 10 patients on IMBRUVICA® + rituximab were still alive at 54 months1†

PFS benefit and high response rate regardless of:1

Prior treatment status Genotype Patient characteristics (age, sex, serum

immunoglobulin, Hgb, and IPSSWM)

IPSSWM: International Prognostic Scoring System for Waldenström Macroglobulinemia


Longer time to next treatment

vs. rituximab + placebo1

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Consistent safety profile

with long-term treatment1*

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iNNOVATETM substudy in rituximab-refractory patients – final analysis2

For heavily pre-treated, rituximab-refractory WM patients, IMBRUVICA® monotherapy continues to deliver sustained efficacy over 5 years (n=31).

Sustained efficacy at 5 years

in heavily pre-treated, rituximab-refractory

WM patients2

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Rapid & sustained IgM and HgB improvements2

71% experienced sustained improvement in Hgb, including 81% patients with baseline Hgb ≤110 g/L2II

Take control with IMBRUVICA®

  • IMBRUVICA® + rituximab Achieve long-lasting PFS with a chemotherapy-free approach for patients with 1L WM1,4
  • IMBRUVICA® monotherapy Offer patients with R/R WM the chance to regain lasting disease control with IMBRUVICA®1,5
  • IMBRUVICA® has a well established tolerability profile in WM1,4,5
  • IMBRUVICA® is the only recommended BTKi for WM in Europe6

Only IMBRUVICA® is backed by the experience and evidence that comes with treating over 200,000 patients in multiple indications (CLL, R/R MCL, WM) with up to 8 years of follow-up in clinical trials and in the real world5, 7-10

* 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

References

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.

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