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Drug Evaluation

Evaluating orelabrutinib as a novel treatment option for relapsed/refractory chronic lymphocytic leukemia in China

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Pages 1979-1986 | Received 14 Jun 2022, Accepted 31 Oct 2022, Published online: 11 Nov 2022

References

  • Chiorazzi N, Rai KR, Ferrarini M. Chronic lymphocytic leukemia. N Engl J Med. 2005;352(8):804–815.
  • Hallek M, Shanafelt TD, Eichhorst B. Chronic lymphocytic leukaemia. Lancet. 2018;391(10129):1524–1537.
  • Santos FPS, O’Brien S. Small lymphocytic lymphoma and chronic lymphocytic leukemia: are they the same disease? Cancer J. 2012;18(5):396–403.
  • Fischer K, Bahlo J, Fink AM, et al. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016;127(2):208–215.
  • Eichhorst B, Fink A-M, Bahlo J, et al. First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2016;17:928–942.
  • Zhu J, Ma J. Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines for malignant lymphoma 2021 (English version). Chin J Cancer Res. 2021;33:289.
  • Burger JA, Wiestner A. Targeting B cell receptor signalling in cancer: preclinical and clinical advances. Nat Rev Cancer. 2018;18:148–167.
  • Vetrie D, Vořechovský I, Sideras P, et al. The gene involved in X-linked agammaglobulinaemia is a member of the src family of protein-tyrosine kinases. Nature. 1993;361:226–233.
  • Byrd JC, Furman RR, Coutre SE, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369:32–42.
  • Fraser GA, Chanan-Khan A, Demirkan F, 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. Leuk Lymphoma. 2020;61(13):3188–3197.
  • Fraser G, Cramer P, Demirkan F, et al. Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. Leukemia. 2019;33(4):969–980.
  • Byrd JC, Hillmen P, O’Brien S, et al., Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab. Blood. 2019. 133(19): 2031–2042.
  • Stephens DM, Byrd JC. How I manage ibrutinib intolerance and complications in patients with chronic lymphocytic leukemia. Blood. 2019;133(12):1298–1307.
  • Mato AR, Nabhan C, Thompson MC, et al. Toxicities and outcomes of 616 ibrutinib-treated patients in the United States: a real-world analysis. Haematologica. 2018;103(5):874.
  • Jiang R, Li J, Zhu HT-L. Combined regimen in chronic lymphocytic leukemia: a promising strategy to achieve a drug holiday. Curr Med Sci. 2021;41(3):431–442.
  • Byrd JC, Hillmen P, Ghia P, et al., Acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia: results of the first randomized phase III trial. J clin oncol. 2021. 39(31): 3441–3452.
  • Hillmen P, Eichhorst B, Brown JR, 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. In Proceedings of the 2021 European Hematology Association Virtual Congress. 2021.
  • Dhillon S. Orelabrutinib: first approval. Drugs. 2021;81(4):503–507.
  • Huang H, Miao H, Wang J, et al. Advances on anticancer new drugs in China and the USA in 2020: from ongoing trial to drug approval. Journal of the National Cancer Center. 2021;1(4):147–152.
  • NMPA. China national medical products administration approval of orelabrutinib. 2020 Dec 25. https://www.nmpa.gov.cn/directory/web/nmpa/zhuanti/ypqxgg/gggzjzh/20201225204130191.html
  • Zhang B, Zhao R, Liang R, et al., Abstract CT132: orelabrutinib, a potent and selective Bruton’s tyrosine kinase inhibitor with superior safety profile and excellent PK/PD properties. Cancer Res. 2020. 80(16_Supplement): CT132–CT.
  • Liu X, Pang X, Pang X, et al. Progress in the development of small molecular inhibitors of the Bruton’s tyrosine kinase (BTK) as a promising cancer therapy. Bioorg Med Chem. 2021;47:116358.
  • InnoCare. InnoCare announces the approval of orelabrutinib in china for patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma and relapsed/refractory mantle cell lymphoma. 2020 Dec 25. https://www.innocarepharma.com/en/media/press-release/20201227
  • Xu W, Song Y, Wang T, et al., Updated results from the phase II study of orelabrutinib monotherapy in Chinese patients with relapsed or refractory chronic lymphocytic leukemia/small cell leukemia. Blood. 2020. 136(1): 26–27.
  • Xu W, Song Y, Wang T, et al., Orelabrutinib monotherapy in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: updated long term results of phase II study. Blood. 2021. 138(1): 2638.
  • Song Y, Song Y, Liu L, et al. Long-term safety and efficacy of orelabrutinib monotherapy in Chinese patients with relapsed or refractory mantle cell lymphoma: a multicenter, open-label, phase II study. Blood. 2020;136(1):1.
  • Xu W, Song Y, Wang T, et al. Updated efficacy and safety results of orelabrutinib in the treatment of relapsed or refractory chronic lymphocytic leukemia/small cell leukemia. Hematol Oncol. 2021;39(S2): Abstract 131.
  • Byrd JC, Harrington B, O’Brien S, et al. Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N Engl J Med. 2016;374(4):323–332.
  • Byrd JC, Wierda WG, Schuh A, et al. Acalabrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia: updated phase 2 results. Blood. 2020;135(15):1204–1213.
  • Tam CS, Trotman J, Opat S, et al. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134(11):851–859.
  • Cull G, Burger JA, Opat S, et al. Zanubrutinib for treatment‐naïve and relapsed/refractory chronic lymphocytic leukaemia: long‐term follow‐up of the phase I/II AU‐003 study. Br J Haematol. 2022;196(5):1209–1218.
  • Byrd JC, Furman RR, Coutre SE, et al. Ibrutinib treatment for first-line and relapsed/refractory chronic lymphocytic leukemia: final analysis of the pivotal phase Ib/II PCYC-1102 study. Clin Cancer Res. 2020;26(15):3918–3927.
  • Xu W, Yang S, Zhou K, et al. Treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma with the BTK inhibitor zanubrutinib: phase 2, single-arm, multicenter study. J Hematol Oncol. 2020;13(1):1–12.
  • Song Y, Xu W, Song Y, et al. Pooled analysis of safety data from clinical trials of orelabrutinib monotherapy in hematologic malignancies. Blood. 2020;136(Supplement 1):43.
  • Song Y, Song Y, Liu L, et al. Safety and efficacy of orelabrutinib monotherapy in Chinese patients with relapsed or refractory mantle cell lymphoma: a multicenter, open-label, phase II study. Blood. 2019;134(Supplement_1):755.
  • Sermer D, Sarosiek S, Branagan AR, et al. SOHO state of the art updates and next questions: targeted therapies and emerging novel treatment approaches for waldenström macroglobulinemia. Clin Lymphoma Myeloma Leukemia. 2022;22(8):547–556.
  • O’Brien S, Furman RR, Coutre S, et al. Single-agent ibrutinib in treatment-naïve and relapsed/refractory chronic lymphocytic leukemia: a 5-year experience. Blood. 2018;131(17):1910–1919.
  • Maddocks KJ, Ruppert AS, Lozanski G, et al. Etiology of ibrutinib therapy discontinuation and outcomes in patients with chronic lymphocytic leukemia. JAMA Oncol. 2015;1(1):80–87.
  • Jain P, Keating M, Wierda W, et al. Outcomes of patients with chronic lymphocytic leukemia after discontinuing ibrutinib. Blood. 2015;125(13):2062–2067.

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