2,228
Views
1
CrossRef citations to date
0
Altmetric
Articles

A phase 1, open-label, randomized drug–drug interaction study of zanubrutinib with moderate or strong CYP3A inhibitors in patients with B-cell malignancies

ORCID Icon, , , , , , , , , & ORCID Icon show all
Pages 329-338 | Received 16 Aug 2022, Accepted 16 Nov 2022, Published online: 08 Dec 2022

References

  • Niemann CU, Wiestner A. B-cell receptor signaling as a driver of lymphoma development and evolution. Semin Cancer Biol. 2013;23(6):410–421.
  • Rickert RC. New insights into pre-BCR and BCR signalling with relevance to B cell malignancies. Nat Rev Immunol. 2013;13(8):578–591.
  • Brukinsa (zanubrutinib) [package insert]. San Mateo, CA: BeiGene USA, Inc.; 2021; Available from: https://www.brukinsa.com/prescribing-information.pdf. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s005lbl.pdf
  • Tam C, Grigg AP, Opat S, et al. The BTK inhibitor, BGB-3111, is safe, tolerable, and highly active in patients with relapsed/refractory B-cell malignancies: initial report of a phase 1 first-in-human trial. Blood. 2015;126(23):832–832.
  • Guo Y, Liu Y, Hu N, et al. Discovery of zanubrutinib (BGB-3111), a novel, potent, and selective covalent inhibitor of Bruton’s tyrosine kinase. J Med Chem. 2019;62(17):7923–7940.
  • Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015;373(25):2425–2437.
  • Byrd JC, Furman RR, Coutre SE, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369(1):32–42.
  • Byrd JC, Brown JR, O'Brien S, et al. Ibrutinib versus of atumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371(3):213–223.
  • Farooqui MZ, Valdez J, Martyr S, et al. Ibrutinib for previously untreated and relapsed or refractory chronic lymphocytic leukaemia with TP53 aberrations: a phase 2, single-arm trial. Lancet Oncol. 2015;16(2):169–176.
  • Maddocks K, Jones JA. Bruton tyrosine kinase inhibition in chronic lymphocytic leukemia. Semin Oncol. 2016;43(2):251–259.
  • Wang ML, Blum KA, Martin P, et al. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results. Blood. 2015;126(6):739–745.
  • Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013;369(6):507–516.
  • Treon SP, Tripsas CK, Meid K, et al. Ibrutinib in previously treated Waldenstrom’s macroglobulinemia. N Engl J Med. 2015;372(15):1430–1440.
  • Tam CS, LeBlond V, Novotny W, et al. A head-to-head phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenstrom macroglobulinemia. Future Oncol. 2018;14(22):2229–2237.
  • Tam CS, Opat S, D'Sa S, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: the ASPEN study. Blood. 2020;136(18):2038–2050.
  • Hillmen P, Eichhorst B, Brown JR, et al. Zanubrutinib versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma: interim analysis of a randomized phase III trial. J Clin Oncol. 2022;JCO2200510.
  • Imbruvica (ibrutinib) [package insert]. South San Francisco, CA: Pharmacyclics LLC; 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s030,210563s006lbl.pdf.
  • Calquence (acalabrutinib) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf
  • Bruggemann RJ, Alffenaar JW, Blijlevens NM, et al. Clinical relevance of the pharmacokinetic interactions of azole antifungal drugs with other coadministered agents. Clin Infect Dis. 2009;48(10):1441–1458.
  • de Jong J, Skee D, Murphy J, et al. Effect of CYP3A perpetrators on ibrutinib exposure in healthy participants. Pharmacol Res Perspect. 2015;3(4):e00156.
  • Mu S, Tang Z, Novotny W, et al. Effect of rifampin and itraconazole on the pharmacokinetics of zanubrutinib (a Bruton’s tyrosine kinase inhibitor) in Asian and non-Asian healthy subjects. Cancer Chemother Pharmacol. 2020;85(2):391–399.
  • Owen RG, Kyle RA, Stone MJ, et al. Response assessment in Waldenstrom macroglobulinaemia: update from the VIth international workshop. Br J Haematol. 2013;160(2):171–176.
  • Anderson KC, Alsina M, Bensinger W, et al. Waldenstrom’s macroglobulinemia/lymphoplasmacytic lymphoma, version 2.2013. J Natl Compr Canc Netw. 2012;10(10):1211–1219.
  • Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32(27):3059–3068.
  • Hallek M. Chronic lymphocytic leukemia: 2017 update on diagnosis, risk stratification, and treatment. Am J Hematol. 2017;92(9):946–965.
  • Guyot A, Rawlins MD, Barrett SP. Clarithromycin appears to be linked with Clostridium difficile-associated diarrhoea in the elderly. J Antimicrob Chemother. 2000;46(4):642–643.
  • Ushiama H, Echizen H, Nachi S, et al. Dose-dependent inhibition of CYP3A activity by clarithromycin during Helicobacter pylori eradication therapy assessed by changes in plasma lansoprazole levels and partial cortisol clearance to 6beta-hydroxycortisol. Clin Pharmacol Ther. 2002;72(1):33–43.
  • Gorski JC, Jones DR, Haehner-Daniels BD, et al. The contribution of intestinal and hepatic CYP3A to the interaction between midazolam and clarithromycin. Clin Pharmacol Ther. 1998;64(2):133–143.
  • Kapetas AJ, Abuhelwa AY, Sorich MJ, et al. Evidence-based guidelines for drug interaction studies: model-Informed time course of intestinal and hepatic CYP3A4 inhibition by clarithromycin. AAPS J. 2021;23(5):104.
  • Ou YC, Tang Z, Novotny W, et al. Rationale for once-daily or twice-daily dosing of zanubrutinib in patients with mantle cell lymphoma. Leuk Lymphoma. 2021;62(11):2612–2624.
  • Wang K, Yao X, Zhang M, et al. Comprehensive PBPK model to predict drug interaction potential of zanubrutinib as a victim or perpetrator. CPT Pharmacometrics Syst Pharmacol. 2021;10(5):441–454.
  • Coutant DE, Kulanthaivel P, Turner PK, et al. Understanding disease-drug interactions in cancer patients: implications for dosing within the therapeutic window. Clin Pharmacol Ther. 2015;98(1):76–86.
  • Bolleddula J, Ke A, Yang H, et al. PBPK modeling to predict drug-drug interactions of ivosidenib as a perpetrator in cancer patients and qualification of the simcyp platform for CYP3A4 induction. CPT Pharmacometrics Syst Pharmacol. 2021;10(6):577–588.
  • Ou YC, Liu L, Tariq B, et al. Population pharmacokinetic analysis of the BTK inhibitor zanubrutinib in healthy volunteers and patients with B-cell malignancies. Clin Transl Sci. 2021;14(2):764–772.
  • Tam CS, Dimopoulos M, Garcia-Sanz R, et al. Pooled safety analysis of zanubrutinib monotherapy in patients with B-cell malignancies. Blood Adv. 2022;6(4):1296–1308.
  • Tam CSL, Garcia-Sanz R, Opat S, et al. ASPEN: long-term follow-up results of a phase 3 randomized trial of zanubrutinib (ZANU) versus ibrutinib (IBR) in patients with Waldenström macroglobulinemia (WM). J Clin Oncol. 2022;40(16_suppl):7521–7521.