Efficacy and safety of blinatumomab in Chinese adults with Ph-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia: A multicenter open-label single-arm China registrational study

References

• Yi M, Zhou L, Li A, et al. Global burden and trend of acute lymphoblastic leukemia from 1990 to 2017. Aging. 2020;12(22):22869–91.
   PubMedGoogle Scholar
• Barlev A, Lin VW, Katz A, et al. Estimating long-term survival of adults with Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia treated with blinatumomab using historical data. Adv Ther. 2017;34(1):148–55.
   PubMed Web of Science ®Google Scholar
• Gökbuget N, Stanze D, Beck J, et al. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012;120(10):2032–41.
   PubMed Web of Science ®Google Scholar
• O'Brien S, Thomas D, Ravandi F, et al. Outcome of adults with acute lymphocytic leukemia after second salvage therapy. Cancer. 2008;113(11):3186–91.
   PubMed Web of Science ®Google Scholar
• Wei G, Wang J, Huang H, et al. Novel immunotherapies for adult patients with B-lineage acute lymphoblastic leukemia. J Hematol Oncol. 2017;10(1):150.
   PubMed Web of Science ®Google Scholar
• Oriol A, Vives S, Hernández-Rivas JM, et al. Outcome after relapse of acute lymphoblastic leukemia in adult patients included in four consecutive risk-adapted trials by the PETHEMA study group. Haematologica. 2010;95(4):589–96.
   PubMed Web of Science ®Google Scholar
• El Fakih R, Ahmed S, Alfraih F, et al. Hematopoietic cell transplantation for acute lymphoblastic leukemia in adult patients. Hematol Oncol Stem Cell Ther. 2017;10(4):252–8.
   PubMedGoogle Scholar
• Marks DI, Alonso L, Radia R. Allogeneic hematopoietic cell transplantation in adult patients with acute lymphoblastic leukemia. Hematol Oncol Clin North Am. 2014;28(6):995–1009.
   PubMed Web of Science ®Google Scholar
• Stein A, Franklin JL, Chia VM, et al. Benefit-risk assessment of blinatumomab in the treatment of relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Drug Saf. 2019;42(5):587–601.
   PubMed Web of Science ®Google Scholar
• Bargou R, Leo E, Zugmaier G, et al. Tumor regression in cancer patients by very low doses of a T cell-engaging antibody. Science (New York, NY). 2008;321(5891):974–7.
   Google Scholar
• Löffler A, Gruen M, Wuchter C, et al. Efficient elimination of chronic lymphocytic leukaemia B cells by autologous T cells with a bispecific anti-CD19/anti-CD3 single-chain antibody construct. Leukemia. 2003;17(5):900–9.
   PubMed Web of Science ®Google Scholar
• Zhao J, Song Y, Liu D. Recent advances on blinatumomab for acute lymphoblastic leukemia. Exp Hematol Oncol. 2019;8:28.
   PubMed Web of Science ®Google Scholar
• Li L, Wang Y. Recent updates for antibody therapy for acute lymphoblastic leukemia. Exp Hematol Oncol. 2020;9(1):33.
   PubMed Web of Science ®Google Scholar
• Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376(9):836–47.
   PubMed Web of Science ®Google Scholar
• Topp MS, Gökbuget N, Stein AS, et al. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015;16(1):57–66.
   PubMed Web of Science ®Google Scholar
• Locatelli F, Zugmaier G, Rizzari C, et al. Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia: A randomized clinical trial. JAMA. 2021;325(9):843–54.
   PubMed Web of Science ®Google Scholar
• Brown PA, Ji L, Xu X, et al. Effect of postreinduction therapy consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia: A randomized clinical trial. JAMA. 2021;325(9):833–42.
   PubMed Web of Science ®Google Scholar
• Gökbuget N, Dombret H, Bonifacio M, et al. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018;131(14):1522–31.
   PubMed Web of Science ®Google Scholar
• Brown PA, Wieduwilt M, Logan A, et al. Guidelines insights: acute lymphoblastic leukemia, version 1.2019. J Natl Compr Cancer Netw. 2019;17(5):414–23.
   PubMed Web of Science ®Google Scholar
• Curran E, Stock W. Taking a “BiTE out of ALL”: blinatumomab approval for MRD-positive ALL. Blood. 2019;133(16):1715–9.
   PubMed Web of Science ®Google Scholar
• Kiyoi H, Morris JD, Oh I, et al. Phase 1b/2 study of blinatumomab in Japanese adults with relapsed/refractory acute lymphoblastic leukemia. Cancer Sci. 2020;111(4):1314–23.
   PubMed Web of Science ®Google Scholar
• O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35(3):549–56.
   PubMed Web of Science ®Google Scholar
• Gökbuget N, Kelsh M, Chia V, et al. Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia. Blood Cancer J. 2016;6(9):e473.
   PubMedGoogle Scholar
• Thomas DA, Kantarjian H, Smith TL, et al. Primary refractory and relapsed adult acute lymphoblastic leukemia: characteristics, treatment results, and prognosis with salvage therapy. Cancer. 1999;86(7):1216–30.
   PubMed Web of Science ®Google Scholar
• Ma J, Liu T, Jin J, et al. An observational study of Chinese adults with relapsed/refractory Philadelphia-negative acute lymphoblastic leukemia. Int J Hematol Oncol. 2018;7(2):IJH06.
   PubMedGoogle Scholar
• Kantarjian HM, DeAngelo DJ, Stelljes M, et al. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019;125(14):2474–87.
   PubMed Web of Science ®Google Scholar
• Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018;378(5):439–48.
   PubMed Web of Science ®Google Scholar
• Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16):1507–17.
   PubMed Web of Science ®Google Scholar
• Kantarjian HM, DeAngelo DJ, Stelljes M, et al. Inotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia. N Engl J Med. 2016;375(8):740–53.
   PubMed Web of Science ®Google Scholar
• Wei J, Guo Y, Wang Y, et al. Clinical development of CAR T cell therapy in China: 2020 update. Cell Mol Immunol. 2020; https://doi.org/10.1038/s41423-020-00555-x.
   Google Scholar
• Martinelli G, Boissel N, Chevallier P, et al. Complete hematologic and molecular response in adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia following treatment with blinatumomab: results from a phase II, single-arm, multicenter study. J Clin Oncol. 2017;35(16):1795–802.
   PubMed Web of Science ®Google Scholar