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      Thursday, March 23, 2023
      News & Perspective Drugs & Diseases CME & Education Academy Video Decision Point
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      CPD

      Bruton Tyrosine Kinase Inhibitors for Chronic Lymphocytic Leukemia: Data, Application, and Patient Selection

      • Authors: John Gribben, MD, DSc, FMedSci
      • CPD Released: 9/7/2022
      • Valid for credit through: 9/7/2023
      Start Activity

      • Credits Available

        Non-US Physicians - maximum of 1.00 CPD

        You Are Eligible For

        • Letter of Completion

      Target Audience and Goal Statement

      This educational activity is intended for an international audience of non-US hematology/oncology specialists, pathologists, and cardiologists.

      The goal of this activity is that learners will be better able to improve physician knowledge, competence, and confidence regarding the available clinical data and application of BTK inhibitors for patients with CLL.

      Upon completion of this activity, participants will:

      • Have increased knowledge regarding the
        • Key mechanistic differences between first- and next-generation BTK inhibitors
        • Available clinical data on BTK inhibitors for CLL
        • Different side effect profiles of BTK inhibitors for CLL
      • Have greater competence related to
        • Managing patients with CLL with BTK inhibitors
      • Demonstrate greater confidence in their ability to
        • Understand where next-generation BTK inhibitors fit in the treatment algorithm for CLL

      Disclosures

      WebMD Global requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

      All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated. Others involved in the planning of this activity have no relevant financial relationships with ineligible companies.

      Disclosures for additional planners can be found here.

      Faculty

      • John Gribben, MD, DSc, FMedSci

        Hamilton Fairley Chair of Medical Oncology
        Centre Lead, Centre for Haemato-Oncology
        Barts Cancer Institute
        Queen Mary University of London
        London, United Kingdom

        Disclosures

        John Gribben, MD, DSc, FMedSci, has the following relevant financial relationships:
        Consultant or advisor for: AbbVie; AstraZeneca; TG Therapeutics
        Speaker or member of speakers bureau for: AbbVie; Bristol Myers Squibb; Gilead; Janssen; Kite
        Research funding from: AstraZeneca; Celgene; Janssen

      Editors

      • Keisha Peters, MSc

        Medical Education Director, WebMD Global, LLC

        Disclosures

        Keisha Peters, MSc, has no relevant financial relationships.

      • Lisa Cockrell, PhD

        Medical Education Director, Medscape, LLC

        Disclosures

        Lisa Cockrell, PhD, has no relevant financial relationships.

      Compliance Reviewer

      • Leigh Schmidt, MSN, RN, CNE, CHCP

        Associate Director, Accreditation and Compliance, Medscape, LLC

        Disclosures

        Leigh Schmidt, MSN, RN, CNE, CHCP, has no relevant financial relationships.

      Peer Reviewer

      This activity has been peer reviewed and the reviewer has no relevant financial relationships.

      Accreditation Statements

        For Physicians

      • The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom (FPM) has reviewed and approved the content of this educational activity and allocated it 1.0 continuing professional development credits (CPD).

        Contact WebMD Global

      For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]

      Instructions for Participation and Credit

      There are no fees for participating in or receiving credit for this online educational activity. For information about your eligibility to claim credit, please consult your professional licensing board.

      This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent participating in the activity. To successfully earn credit, participants must complete the activity online during the credit eligibility period that is noted on the title page.

      Follow these steps to claim a credit certificate for completing this activity:

      1. Read the information provided on the title page regarding the target audience, learning objectives, and author disclosures, read and study the activity content and then complete the post-test questions. If you earn a passing score on the post-test and we have determined based on your registration profile that you may be eligible to claim CPD credit for completing this activity, we will issue you a CPD credit certificate.
      2. Once your CPD credit certificate has been issued, you may view and print the certificate from your CME/CE Tracker. CPD credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of the Medscape Education homepage.

      We encourage you to complete an Activity Evaluation to provide feedback for future programming.

      You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.

      *The credit that you receive is based on your user profile.

      < CLINICAL ADVANCES IN BTK Inhibition for B-Cell Malignancies
      From Medscape Education
      CPD

      Bruton Tyrosine Kinase Inhibitors for Chronic Lymphocytic Leukemia: Data, Application, and Patient Selection

      Authors: John Gribben, MD, DSc, FMedSciFaculty and Disclosures

      CPD Released: 9/7/2022

      Valid for credit through: 9/7/2023

      processing....

      References

      1. Tambaro FP, et al. The role of BTK inhibition in the treatment of chronic lymphocytic leukemia: a clinical view. J Exp Pharmacol. 2021;13:923-935.
      2. Ibrutinib Product Information. European Medicines Agency (EMA). Published October 21, 2014. Updated June 25, 2019. Accessed July 27, 2022. https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf
      3. Acalabrutinib Product Information. European Medicines Agency (EMA). Published November 5, 2020. Accessed July 27, 2022. https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf
      4. Zanubrutinib Product Information. European Medicines Agency (EMA). Published November 22, 2021. Accessed July 27, 2022. https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf
      5. Wen T, et al. Inhibitors targeting Bruton's tyrosine kinase in cancers: drug development advances. Leukemia. 2021;35:312-332.
      6. Kaptein A, et al. Potency and selectivity of BTK inhibitors in clinical development for B-cell malignancies. Blood. 2018;132:1871.
      7. Berglöf A, et al. Targets for ibrutinib beyond B cell malignancies. Scand J Immunol. 2015;82:208-217.
      8. Estupiñán HY, et al. Comparative analysis of BTK inhibitors and mechanisms underlying adverse effects. Front Cell Dev Biol. 2021;9:630942.
      9. Burger JA, et al; RESONATE-2 Investigators. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015;373:2425-2437.
      10. Byrd JC, et al; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371:213-223.
      11. 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.
      12. Byrd JC, et al. Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab. Blood. 2019;133:2031-2042.
      13. Barr PM, et al. Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv. 2022;6:3440-3450.
      14. Munir T, et al. Final analysis from RESONATE: up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J Hematol. 2019;94:1353-1363.
      15. Sharman JP, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020;395:1278-1291.
      16. Ghia P, et al. ASCEND: phase III, randomized trial of acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukemia. J Clin Oncol. 2020;38:2849-2861.
      17. Sharman JP, et al. Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia. Leukemia. 2022;36:1171-1175.
      18. Jurczak W, et al. Acalabrutinib versus rituximab plus idelalisib or bendamustine in relapsed/refractory chronic lymphocytic leukemia: ASCEND results at 4 years of follow-up. Presented at: American Society of Clinical Oncology Annual Meeting; June 3-6, 2022; Chicago, IL. Presentation 7538.
      19. Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: five-year follow-up of ELEVATE-TN. Presented at: American Society of Clinical Oncology Annual Meeting; June 3-6, 2022; Chicago, IL. Presentation 7539.
      20. Sharman JP, et al. Acalabrutinib ± obinutuzumab vs obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: 5-year follow-up of ELEVATE-TN. Presented at: European Hematology Association Hybrid Congress; June 9-12, 2022; Vienna, Austria. Presentation P666.
      21. Tam CS, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23:1031-1043.
      22. 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;18:803-813.e7.
      23. Walker P, et al. Patient-reported outcomes from the phase 3, randomized study of acalabrutinib with or without obinutuzumab versus chlorambucil plus obinutuzumab for treatment-naïve chronic lymphocytic leukemia (ELEVATE-TN). Value Health. 2021;12:53.
      24. Ghia P, et al. Acalabrutinib vs rituximab plus idelalisib or bendamustine in relapsed/refractory chronic lymphocytic leukemia: ASCEND results at ~4 years of follow-up. Presented at: European Hematology Association Hybrid Congress; June 9-12, 2022; Vienna, Austria. Presentation P668.
      25. Byrd JC, et al. Acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia: results of the first randomized phase III trial. J Clin Oncol. 2021;39:3441-3452.
      26. Hillmen P, et al. ALPINE: zanubrutinib versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Future Oncol. 2020;16:517-523.
      27. Hillmen P, et al. First interim analysis of ALPINE study: results of a phase 3 randomized study of zanubrutinib vs ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Presented at: European Hematology Association Virtual Annual Meeting; June 9-17, 2021. Abstract LB1900. https://library.ehaweb.org/eha/2021/eha2021-virtual-congress/330170/peter.hillmen.first.interim.analysis.of.alpine.study.results.of.a.phase.3.html
      28. Byrd JC, et al. First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia. Presented at: American Society of Clinical Oncology Virtual Annual Meeting; June 4-8, 2022; Chicago, IL. Presentation 7500. https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.7500
      29. Hillmen P, et al. Health-related quality of life outcomes associated with zanubrutinib vs ibrutinib monotherapy in patients with relapsed/refractory (RR) CLL/SLL: Results From The Randomized Phase 3 ALPINE trial. Presented at: European Hematology Association Hybrid Congress; June 9-12, 2022; Vienna, Austria. Presentation P663.
      30. Lipsky A, et al. Managing toxicities of Bruton tyrosine kinase inhibitors. Hematology Am Soc Hematol Educ Program. 2020;2020:336-345.
      31. de Weerdt I, et al. Incidence and management of toxicity associated with ibrutinib and idelalisib: a practical approach. Haematologica. 2017;102:1629-1639.
      32. Mato AR, et al. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021;397:892-901.
      33. Mato A. A first-in-human phase 1 trial of NX-2127, a first-in-class oral BTK Degrader with immunomodulatory activity, in patients with relapsed and refractory B-cell malignancies. Poster presented at: European Hematology Association Hybrid Congress; June 9-12, 2022; Vienna, Austria. Presentation P649.
      34. ClinicalTrials.gov. A study of pirtobrutinib (LOXO-305) versus ibrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (BRUIN-CLL-314). Accessed July 27, 2022. https://clinicaltrials.gov/ct2/show/NCT05254743
      35. Woyach J, et al. Nemtabrutinib (MK-1026), a noncovalent inhibitor of wild-type and C481S-mutated Bruton tyrosine kinase for B-cell malignancies: efficacy and safety of the phase 2 dose-expansion BELLWAVE-001 study. Poster presented at: European Hematology Association Hybrid Congress; June 9-12, 2022; Vienna, Austria. Poster P682.
      36. Shanafelt TD, et al. Ibrutinib-rituximab or chemoimmunotherapy for chronic lymphocytic leukemia. N Engl J Med. 2019;381:432-443.
      37. Hillmen P, Pitchford A, Bloor A, et al. Ibrutinib plus rituximab is superior to FCR in previously untreated CLL: results of the phase III NCRI FLAIR trial. Blood. 2021;138 (Supplement 1): 642.
      38. Tedeschi A, et al. Chronic lymphocytic leukemia (CLL) patients quality of life (QoL): a cross-sectional analysis of the Italian experience in the Choice study during the first wave of the COVID-19 pandemic. Presented at: American Society of Hematology 2021 Annual Meeting; December 11-14, 2021; Atlanta, GA. Abstract 67.
      39. ClinicalTrials.gov. Study of acalabrutinib (ACP-196) in combination with venetoclax (ABT-199), with and without obinutuzumab (GA101) versus chemoimmunotherapy for previously untreated CLL. Accessed July 27, 2022. https://clinicaltrials.gov/ct2/show/NCT03836261
      40. ClinicalTrials.gov. Study of APG2575 single agent and combination therapy in patients with relapsed/refractory CLL/SLL. Accessed July 27, 2022. https://clinicaltrials.gov/ct2/show/NCT04494503
      41. ClinicalTrials.gov. Study of Bcl-2 Inhibitor BGB-11417 in participants with mature B-Cell malignancies. https://clinicaltrials.gov/ct2/show/NCT04277637
      42. Tam CS, et al. Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort. Blood. 2022;139:3278-3289.
      43. Kater AP, et al. Fixed-duration ibrutinib-venetoclax in patients with chronic lymphocytic leukemia and comorbidities. NEJM Evidence. 2022;1:1-13.
      « Return to: Bruton Tyrosine Kinase Inhibitors for Chronic Lymphocytic Leukemia: Data, Application, and Patient Selection
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