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The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene and Roche, and supported through educational grants from Bristol Myers Squibb, Ipsen Biopharmaceuticals, Lilly, Pfizer, and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC View funders.

2024-11-19T10:22:24.000Z

Symposium | Customizing first-line BTK inhibitors for CLL: Unmet needs with BTK inhibitors

Nov 19, 2024
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Learning objective: After reading this article, learners will be able to recall the regulatory status of BTK inhibitors and the key treatment guidelines for first-line CLL.

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Symposium | Customizing first-line BTK inhibitors for CLL: Unmet needs with BTK inhibitors

During the Lymphoma Hub virtual symposium on October 23, 2024, entitled Customizing first-line Bruton‘s tyrosine kinase (BTK) inhibitors for chronic lymphocytic leukemia (CLL), Gilles Salles, Memorial Sloan Kettering Cancer Center, New York, US, delivered a presentation on the unmet needs with BTK inhibitors in CLL.

Salles provided an overview of the regulatory status of BTK inhibitors for the first-line treatment of CLL in the US and Europe, touching on the regulatory status of BTK inhibitors as monotherapy and in combination with other therapies, including rituximab, obinutuzumab, bendamustine, and obinutuzumab (Figure 1). Salles also discussed the National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) clinical guidelines for the first-line treatment of CLL (Figure 2).

Figure 1. An overview of the regulatory status of BTK inhibitors for first-line CLL* 

BTK, Bruton’s tyrosine kinase; CLL, chronic lymphocytic leukemia.
*Data from Ibrutinib FDA prescribing information1, Ibrutinib EMA prescribing information2, Acalabrutinib FDA prescribing information3, Acalabrutinib EMA prescribing information4, Zanubrutinib FDA prescribing information5, Zanubrutinib EMA prescribing information6, Pirtobrutinib FDA prescribing information7, ClinicalTrials.gov.8,9
Approved for adult patients with CLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

 

Figure 1. Key guidelines for first-line treatment of CLL*  

CIT, chemoimmunotherapy; CLL, chronic lymphocytic leukemia; del, deletion; ESMO, European Society for Medical Oncology; FCR, fludarabine, cyclophosphamide, rituximab; IGHV, immunoglobulin heavy chain variable; NCCN, National Comprehensive Cancer Network.
*Data from National Comprehensive Cancer Network10 and Eichhorst et al.11
Ibrutinib + venetoclax changed from category 2B to category 2A in the October update.

Watch or download the presentation to learn more about:

  • The regulatory status of BTK inhibitors for first-line CLL, including their approved combinations.
  • The NCCN and ESMO guidelines for first-line CLL, including treatment options for fit or young patients, unfit or older patients, and patients with or without TP53mut or del(17p).

This independent educational activity was supported by an educational grant from Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC. All content was developed independently by SES in collaboration with the faculty. The funder was allowed no influence on the content of this activity.

  1. Imbruvica (ibrutinib) FDA prescribing information. Pharmacyclics LLC; 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/217003s000lbl.pdf. Updated Aug 2022. Accessed Oct 29, 2024.
  2. Imbruvica (ibrutinib) EMA prescribing information. Janssen-Cilag International NV; 2024. European Medicines Agency. https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf. Updated Sep 20, 2024. Accessed Oct 29, 2024.
  3. Calquence (acalabrutinib) FDA prescribing information. AstraZeneca Pharmaceuticals; 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig2s000Correctedlbl.pdf. Updated Aug 2022. Accessed Oct 29, 2024.
  4. Calquence (acalabrutinib) EMA prescribing information. AstraZeneca AB; 2024. European Medicines Agency. https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf. Updated Feb 19, 2024. Accessed Oct 29, 2024.
  5. Brukinsa (zanubrutinib) FDA prescribing information. BeiGene USA, Inc.; 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217s011lbl.pdf. Updated Mar 2024. Accessed Oct 29, 2024.
  6. Brukinsa (zanubrutinib) EMA prescribing information. BeiGene Switzerland GmbH; 2024. European Medicines Agency. https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf. https://www.ema.europa.eu/en/documents/rmp-summary/brukinsa-epar-risk-management-plan-summary_en.pdf Updated Sep 20, 2024. Accessed Oct 29, 2024.
  7. Jayprica (pirtobrutinib) FDA prescribing information. Lilly USA, LLC; 2022. https://pi.lilly.com/us/jaypirca-uspi.pdf. Updated Jun 2024. Accessed Oct 29, 2024.
  8. ClinicalTrials.gov. Study of LOXO-305 versus investigator's choice (IdelaR or BR) in patients with previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (BRUIN CLL-321). https://clinicaltrials.gov/study/NCT04666038. Updated Jul 24, 2024. Accessed Oct 29, 2024.
  9. ClinicalTrials.gov. A study of nemtabrutinib (MK-1026) versus comparator (investigator's choice of ibrutinib or acalabrutinib) in first line (1L) chronic lymphocytic leukemia (CLL)/​ small lymphocytic lymphoma (SLL) (MK-1026-011/​BELLWAVE-011). https://clinicaltrials.gov/study/NCT06136559. Updated Oct 21, 2024. Accessed Oct 29, 2024.
  10. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines) chronic lymphocytic leukemia/small lymphocytic lymphoma. Version 1.2025. https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed Oct 29, 2024.
  11. Eichhorst B, Ghia P, Niemann C, et al. ESMO clinical practice guideline interim update on new targeted therapies in the first line and at relapse of chronic lymphocytic leukemia. Ann Oncol. 2024;35(9):762-768. DOI: 1016/j.annonc.2024.06.016

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