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Expert Analysis

CME

Key Studies in Leukemias: Independent Conference Coverage of ASH 2020

Physicians: Maximum of 1.25 AMA PRA Category 1 Credits™

Released: February 12, 2021

Expiration: February 11, 2022

Jorge Cortes
Jorge Cortes, MD
Eunice S. Wang
Eunice S. Wang, MD
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  1. Levis. FLT3 mutations in acute myeloid leukemia: what is the best approach in 2013? Hematology Am Soc Hematol Educ Program. 2013;2013:220-226.
  2. Gilteritinib [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; 2019.
  3. US Food and Drug Administration. FDA approves addition of survival data to gilteritinib label for refractory AML with a FLT3 mutation. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-addition-survival-data-gilteritinib-label-refractory-aml-flt3-mutation. Accessed February 5, 2021.
  4. Midostaurin [package insert]. East Hanover, NJ: Novartis Pharmaceuticals; 2020.
  5. Pratz KW, Cherry M, Altman JK, et al. A phase 1 study of gilteritinib in combination with induction and consolidation chemotherapy in patients with newly diagnosed AML: final results. Program and abstracts of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 24.
  6. Stone RM, Mandrekar SJ, Sanford BL, et al. Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation. N Engl J Med. 2017;377:454-464.
  7. ClinicalTrials.gov. Randomized trial of gilteritinib vs midostaurin in FLT3 mutated acute myeloid leukemia. Available at: https://clinicaltrials.gov/ct2/show/NCT03836209?term=NCT03836209&draw=2&rank=1. Accessed February 5, 2021.
  8. ClinicalTrials.gov. A study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes with excess blasts-2 with FLT3 mutations eligible for intensive chemotherapy (HOVON 156 AML). Available at: https://clinicaltrials.gov/ct2/show/NCT04027309?term=NCT04027309&draw=2&rank=1. Accessed February 5, 2021.
  9. Burnett AK, Russell NH, Hills RK, et al. A randomized comparison of daunorubicin 90 mg/m2 vs 60 mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients. Blood. 2015;125:3878-385.
  10. Lee JH, Kim H, Joo YD, et al. Prospective randomized comparison of idarubicin and high-dose daunorubicin in induction chemotherapy for newly diagnosed acute myeloid leukemia. J Clin Oncol. 2017;35:2754-2763.
  11. Daver N, Schlenk RF, Russell NH, et al. Targeting FLT3 mutations in AML: review of current knowledge and evidence. Leukemia. 2019;33:299-312.
  12. Sallman DA, Asch AS, Kambhampati S, et al. The first-in-class anti-CD47 antibody magrolimab combined with azacitidine is well-tolerated and effective in AML patients: phase 1b results. Program and abstracts of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 330.
  13. Chao MP, Takimoto CH, Feng DD, et al. Therapeutic targeting of the macrophage immune checkpoint CD47 in myeloid malignancies. Front Oncol. 2020;9:1380.
  14. Kim K, Maiti A, Kadia TM, et al. Outcomes of TP53-mutant acute myeloid leukemia with venetoclax and decitabine. Program and abstracts of the of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 693.
  15. DiNardo CD, Pratz K, Pullarkat V, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019;133:7-17.
  16. DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and venetoclax in previously untreated acute myeloid leukemia. N Engl J Med. 2020;383:617-629.
  17. Venetoclax [package insert]. North Chicago, IL: AbbVie Inc.; 2020.
  18. Sallman DA, McLemore AF, Aldrich AL, et al. TP53 mutations in myelodysplastic syndromes and secondary AML confer an immunosuppressive phenotype. Blood. 2020[Epub ahead of print].
  19. ClinicalTrials.gov. Magrolimab + azacitidine versus azacitidine + placebo in untreated participants with myelodysplastic syndrome (MDS) (ENHANCE). Available at: https://clinicaltrials.gov/ct2/show/NCT04313881?term=magrolimab&draw=2&rank=1. Accessed February 5, 2021.
  20. Aldoss I, Uy GL, Vey N, et al. Flotetuzumab as salvage therapy for primary induction failure and early relapse acute myeloid leukemia. Program and abstracts of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 331.
  21. Blinatumomab [package insert]. Thousand Oaks, CA: Amgen Inc.; 2020.
  22. Döhner H, Wei AH, Montesinos P, et al. Escalated dosing schedules of CC-486 are effective and well tolerated for patients experiencing first acute myeloid leukemia (AML) Relapse: results from the phase III QUAZAR AML-001 maintenance trial. Program and abstracts of the of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 111.
  23. ClinicalTrials.gov. Efficacy of oral azacitidine plus best supportive care as maintenance therapy in subjects with acute myeloid leukemia in complete remission (QUAZAR AML-001). Available at: https://clinicaltrials.gov/ct2/show/NCT01757535. Accessed February 5, 2021.
  24. Wei AH, Döhner H, Pocock C, et al. The QUAZAR AML-001 maintenance trial: results of a phase III international, randomized, double-blind, placebo-controlled study of CC-486 (oral formulation of azacitidine) in patients with acute myeloid leukemia (AML) in first remission. Program and abstracts of the 61st ASH Annual Meeting; December 7-10, 2019; Orlando, Florida. Abstract LBA-3.
  25. US Food and Drug Administration. FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-onureg-azacitidine-tablets-acute-myeloid-leukemia. Accessed February 5, 2021.
  26. Li GX, Wang L, Yaghmour B, et al. The role of FLT3 inhibitors as maintenance therapy following hematopoietic stem cell transplant. Leuk Res Rep. 2018;10:26-36.
  27. Roboz GJ, Döhner H, Pocock C, et al. Health-related quality of life with CC-486 in patients with acute myeloid leukemia (AML) in first remission following induction chemotherapy (IC): results from the phase III QUAZAR AML-001 maintenance trial. Program and abstracts of the of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 214.
  28. Roboz GJ, Ravandi F, Wei AH, et al. CC-486 prolongs survival for patients with acute myeloid leukemia (AML) in remission after intensive chemotherapy (IC) independent of the presence of measurable residual disease (MRD) at study entry: results from the QUAZAR AML-001 maintenance trial. Program and abstracts of the of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 692.
  29. Ravandi F, Walter RB, Freeman SD. Evaluating measurable residual disease in acute myeloid leukemia. Blood Adv. 2018;2:1356-1366.
  30. Short NJ, Zhou S, Fu C, et al. Association of measurable residual disease with survival outcomes in patients with acute myeloid leukemia: a systematic review and meta-analysis. JAMA Oncol. 2020;6:1890-1899.
  31. Dillon R, Hills R, Freeman S, et al. Molecular MRD status and outcome after transplantation in NPM1-mutated AML. Blood. 2020;135:680-688.
  32. Schuurhuis GJ, Heuser M, Freeman S, et al. Minimal/measurable residual disease in AML: a consensus document from the European LeukemiaNet MRD Working Party. Blood. 2018;131:1275-1291.
  33. Hochhaus A, Boquimpani C, Rea D, et al. Efficacy and safety results from ASCEMBL, a multicenter, open-label, phase 3 study of asciminib, a first-in-class STAMP inhibitor, vs bosutinib in patients with chronic myeloid leukemia in chronic phase previously treated with ≥2 tyrosine kinase inhibitors. Program and abstracts of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract LBA-4.
  34. Manley PW, Barys L, Cowan-Jacob SW. The specificity of asciminib, a potential treatment for chronic myeloid leukemia, as a myristate-pocket binding ABL inhibitor and analysis of its interactions with mutant forms of BCR-ABL1 kinase. Leuk Res. 2020;98:106458.
  35. Wylie AA, Schoepfer J, Jahnke W, et al. The allosteric inhibitor ABL001 enables dual targeting of BCR-ABL1. Nature. 2017;543:733-737.
  36. Schoepfer J, Jahnke W, Berellini G, et al. Discovery of asciminib (ABL001), an allosteric inhibitor of the tyrosine kinase activity of BCR-ABL1. J Med Chem. 2018;61:8120-8135.
  37. Hughes TP, Mauro MJ, Cortes JE, et al. Asciminib in chronic myeloid leukemia after ABL kinase inhibitor failure. N Engl J Med. 2019;381:2315-2326.
  38. Bosutinib [package insert]. Groton, CT: PF PRISM C.V.; 2020.
  39. Etienne G, Dulucq S, Huguet F, et al. Incidence and outcome of BCR-ABL mutated chronic myeloid leukemia patients who failed to tyrosine kinase inhibitors. Cancer Med. 2019;8:5173-5182.
  40. Jabbour E, Kantarjian H, Jones D, et al. Frequency and clinical significance of BCR-ABL mutations in patients with chronic myeloid leukemia treated with imatinib mesylate. Leukemia. 2006;20:1767-1773.
  41. Haguet H, Graux C, Mullier F, et al. Long-term survival, vascular occlusive events and efficacy biomarkers of first-line treatment of CML: a meta-analysis. Cancers (Basel). 2020;12:1242.
  42. Gambacorti-Passerini C, Khoury HJ, Kantarjian HM, et al. Bosutinib as third-line therapy in patients (pts) with chronic phase chronic myeloid leukemia (CP CML) following failure with imatinib plus dasatinib and/or nilotinib: 48-month update of a phase 1/2 study. Program and abstracts of the 56th ASH Annual Meeting; December 6-9, 2014; San Francisco, California. Abstract 4559.
  43. Byrgazov K, Lucini CB, Valent P, et al. BCR-ABL1 compound mutants display differential and dose-dependent responses to ponatinib. Haematologica. 2018;103:e10-e12.
  44. Rea D, Lang F, Kim DW, et al. Asciminib, a specific allosteric BCR-ABL1 inhibitor, in patients with chronic myeloid leukemia carrying the T315I mutation in a phase 1 trial. Program and abstracts of the 60th ASH Annual Meeting; December 1-4, 2018; San Diego, California. Abstract 792.
  45. Cortes JE, Hughes TP, Mauro MJ, et al. Asciminib, a first-in-class STAMP inhibitor, provides durable molecular response in patients (pts) with chronic myeloid leukemia (cml) harboring the T315I mutation: primary efficacy and safety results from a phase 1 trial. Program and abstracts of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 650.
  46. Cortes JE, Lomaia E, Turkina A, et al. Interim analysis (IA) of OPTIC: A dose-ranging study of three ponatinib (PON) starting doses. Program and abstracts of the 2020 ASCO Annual Meeting; May 29 - June 2, 2020. Abstract 7502.
  47. Cortes JE, Apperley J, Hochhaus A, et al. Outcome by mutation status and line of treatment in Optic, a dose-ranging study of 3 starting doses of ponatinib in patients with CP-CML. Program and abstracts of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 48.
  48. Jabbour E, Kantarjian H, Cortes J. Use of second- and third-generation tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia: an evolving treatment paradigm. Clin Lymphoma Myeloma Leuk. 2015;15:323-334.
  49. Kantarjian HM, Deininger MW, Abruzzese E, et al. Efficacy and safety of ponatinib (PON) in patients with chronic-phase chronic myeloid leukemia (CP-CML) who failed one or more second-generation (2G) tyrosine kinase inhibitors (TKIs): analyses based on PACE and Optic. Program and abstracts of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 647.
  50. Cortes JE, Kim DW, Pinilla-Ibarz J, et al. Ponatinib efficacy and safety in Philadelphia chromosome-positive leukemia: final 5-year results of the phase 2 PACE trial. Blood. 2018;132:393-404.
  51. Berman E. Where exactly does ponatinib fit in chronic myelogenous leukemia? J Natl Compr Canc Netw. 2014;12:1615-1620.
  52. Thomas DA, O'Brien S, Faderl S, et al. Chemoimmunotherapy with a modified hyper-CVAD and rituximab regimen improves outcome in de novo Philadelphia chromosome-negative precursor B-lineage acute lymphoblastic leukemia. J Clin Oncol. 2010;28:3880-3889.
  53. Maury S, Chevret S, Thomas X, et al. Rituximab in B-lineage adult acute lymphoblastic leukemia. N Engl J Med. 2016;375:1044-1053.
  54. Berry DA, Zhou S, Higley H, et al. Association of minimal residual disease with clinical outcome in pediatric and adult acute lymphoblastic leukemia: a meta-analysis. JAMA Oncol. 2017;3:e170580.
  55. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376:836-847.
  56. Gökbuget N, Dombret H, Bonifacio M, et al. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018;131:1522-1531.
  57. Short NJ, Kantarjian HM, Ravandi F, et al. Hyper-CVAD and sequential blinatumomab in adults with newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia: results from a phase II study. Program and abstracts of the 62nd ASH Annual Meeting; December 5-8, 2020. Abstract 464.

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