IMBRUVICA offers a wealth of experience for your CLL patients1-3,6,11

Find out more below

Early Use of Imbruvica

Imbruvica® first in the Relapsed/Refractory CLL treatment sequence can make for an efficacious treatment and provides meaningful patient benefits.1,3,4 Early use of Imbruvica® is supported by both published literature and real-world evidence.1,3-5

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All Patients High-risk*

Find out more on the benefits of early use Imbruvica on the Janssen Medical Cloud

Efficacy

IMBRUVICA® offers a track record of experience that you can believe in.1-3,6,11

IMBRUVICA® has extensive clinical experience over 3 B-cell malignancies and real word evidence (RWE).1-3, 6-14

Find out more about Imbruvica's efficacy on the Janssen Medical Cloud

Tolerability - IMBRUVICA is generally well-tolerated over the long term

AEs are generally low Grade in the long term1,2,19

Incidence of most AEs (except hypertension) generally diminishes over time1-3,19

Dose adjustments and discontinuations due to AEs are infrequent and occur mostly in the first year of treatment1,2*

IMBRUVICA clinical trials have included a variety of CLL patients, with 5 CLL studies including high-risk patients such as those with del(17p) or del(11q)1-3, 7,9

Find out more on Imbruvica's tolerability profile on the Janssen Medical Cloud

Patient Benefits

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Click here for Imbruvica patient materials on the Janssen Medical Cloud

Case Studies

Charles received IMBRUVICA 420 mg once daily

A year later, Charles is still on IMBRUVICA therapy and remains well

  • Platelet count monitored closely but improving with prophylaxis
  • No B symptoms
  • No lymph nodes palpable
  • No masses or organomegaly in abdomen

After 2 years of treatment with IMBRUVICA, Charles is continuing to feel well, with no B symptoms

Age:
70

Initially presented with CLL

  • Hb 15.4 g/L, WBC 32.4 x 109/L,
    Platelets 141 x 109/L
  • Persistent lymphocytosis over 2 months
  • ECOG: 0 with uncontrolled atrial fibrillation
  • Unmutated IGHV
76

Treatment approach: watch and wait

Treatment initiation

  • Hb 15.2 g/L, WBC 310 x 109/L,
    Platelets 126 x 109/L
  • Palpable splenomegaly
  • Lymphocyte doubling time <6 months
  • Weight loss >4 kg in less than 2 months

Treatment: 6 cycles FCR

  • Rituximab given at a reduced dose of 100 mg on day 1 and rest of treatment given on day 2 due to risk of tumour lysis.
    • Partial remission at treatment completion
79
  • Flutter ablation procedure
80
  • Hb 128 g/L, WBC 100.2 x 109/L,
    Platelets 148 x 109/L
  • Lymphocyte doubling time <6 months
  • FISH: ATM deletion present, P53 negative, del(17p) negative
81

Progressive disease with ATM mutation (5 years after treatment)

Comorbidities:

  • Previous atrial fibrillation with successful DC cardioversion
  • Hypertension

Find out more on Janssen Medical Cloud

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com

References

  1. Munir T, et al. Final analysis from RESONATE: up to 6 years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J Hematol 2019;94(12):1353-1363.
  2. Burger JA, et al. Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 Study. Leukemia 2020; 34:787-798
  3. Byrd J.C. et al. 2020. Ibrutinib Treatment for First-Line and Relapsed/Refractory Chronic Lymphocytic Leukemia: Final Analysis of the Pivotal Phase 1b/2 PCYC-1102 Study. Clinical cancer research.2020; 26 (15) p.3918-3927
  4. Barr P, et al. Using Ibrutinib in Earlier Lines of Treatment Results in Better Outcomes for Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Poster Presented at the American Society of Hematology Annual Meeting (ASH) December 7–10, 2019; 134 (Suppl) p.3054-3054
  5. Follows G, et al. UK CLL Forum 5 year update on 315 relapsed refractory CLL patients treated with ibrutinib in 66 UK and Ireland centres. Abstract presented at the 61st ASH Annual Meeting & Exposition; 7−10 December 2019; Orange County Convention Center (OCCC), Orlando, FL, USA.
  6. Fraser et al. Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, Leukemia & Lymphoma, 2020; DOI: 10.1080/10428194.2020.1795159
  7. O'Brien SM, et al. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet Oncol 2016;17(10):1409–1418.
  8. Woyach JA, et al. Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL. N Eng J Med 2018;379(26):2517–2528.
  9. Moreno C, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab as first-line treatment in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma: up to 4 years of extended follow-up from the phase iLLUMINATE study. Poster presented at the XVIII International Workshop on CLL (iwCLL) Meeting; 20-23 September 2019;Edinburgh, Scotland. #2069.
  10. Rule S, et al. Ibrutinib versus temsirolimus: 3-year follow-up of patients with previously treated mantle cell lymphoma from the phase 3, international, randomized, open-label RAY study. Leukemia 2018;32(8):1799–1803.
  11. Rule S, et al. Ibrutinib for the treatment of relapsed/refractory mantle cell lymphoma: Extended 3.5-year follow-up from a pooled analysis. Haematologica 2019;104(5):e211−e214.
  12. Treon SP, et al. Ibrutinib monotherapy produces long-term disease control in previously treated Waldenstrom's macroglobulinemia. Final report of the pivotal trial. Haem Onc 2019;37(S2):184–185.
  13. Buske C, et al. Ibrutinib treatment in Waldernström's macroglobulinemia: follow-up efficacy and safety from the iNNOVATETM study. Oral presentation at the 60th ASH Annual Meeting & Exposition; 1−4 December 2018; San Diego, CA, USA.
  14. IMBRUVICA® UK Summary of Product Characteristics. Janssen-Cilag Limited. August 2020
  15. Barr PM, et al. Final analysis from RESONATE: 6-year follow-up in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma on ibrutinib. Poster presented at the American Society of Clinical Oncology (ASCO) Annual Meeting; 31 May−4 June 2019 Chicago, IL, USA.
  16. Byrd JC, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med 2014;371(3):213−223
  17. Jones JA, et al. Use of anticoagulants and antiplatelet in patients with chronic lymphocytic leukaemia treated with single-agent ibrutinib. Br J Haematol 2017; 178:286−291. (supplementary information).
  18. Dartigeas C, et al. French ibrutinib observational study (FIRE): real-world study of ibrutinib treatment for chronic lymphocytic leukemia (CLL) in France. HaemaSphere 2019;3:145−146
  19. O'Brien SM, et al. Safety analysis of four randomized controlled studies of ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma or mantle cell lymphoma. Clin Lymphoma Myeloma Leuk 2018;18(10:648–657.)
  20. Janssen Data on File. Ibrutinib - global number of cumulative patients treated with Ibrutinib since launch. July 2020
  21. Jain P, et al. Long-term outcomes for patients with chronic lymphocytic leukaemia who discontinue ibrutinib. Cancer 2017;15(123):2268–2273
  22. Mato AR, et al. Optimal sequencing of ibrutinib, idelalisib and venetoclax in CLL: Results from a large mutlicenter study of 683 US patients. Ann Oncol 2017;28(5):1050–1056 (Supplementary Appendix)
  23. Barrientos JC, et al. Improvement in parameters of hematologic and immunologic function and patient well-being in the phase III RESONATE study of ibrutinib versus ofatumumab in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma. Clin Lymphoma Myeloma Leuk 2018;18(12):803−813.e7.
  24. CLL Patient Voices Survey Final Report. Janssen. https://janssen.com/emea/sites/www_janssen_com_emea/files cll_patient_voices_survey_results_presenation_2018_05_13.pdf. Last Accessed October 2020.
Date of Preparation: December 2020 | CP-184726