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Drug profile

An evaluation of isatuximab, pomalidomide and dexamethasone for adult patients with relapsed and refractory multiple myeloma

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Pages 419-427 | Received 03 Feb 2021, Accepted 26 Apr 2021, Published online: 16 May 2021

References

  • Annamaria Gulla KCA. Multiple myeloma: the (r) evolution of current therapy and a glance into the future. haematologica. 2020;105(10):10.
  • Mikhael J, Ismaila N, Cheung MC, et al. Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. J Clin Oncol. 2019;37(14):1228–1263.
  • Kumar S, Dimopoulos M, Kastritis E, et al. Natural history of relapsed myeloma, refractory to immunomodulatory drugs and proteasome inhibitors: a multicenter IMWG study. Leukemia. 2017;31(11):2443–2448.
  • Van De Donk NW. Sequencing multiple myeloma therapies with and after antibody therapies. In: Hematology 2014, the american society of hematology education program book. Hematology Am Soc Hematol Educ Program. 2020;Vol. 2020:248–258. 1.
  • Van Beurden-tan CH, Franken MG, Blommestein HM, et al. Systematic literature review and network meta-analysis of treatment outcomes in relapsed and/or refractory multiple myeloma. J Clin Oncol. 2017;35(12):1312–1319.
  • Attal M, Richardson PG, Rajkumar SV, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096–2107.
  • Moreno L, Perez C, Zabaleta A, et al. The mechanism of action of the anti-CD38 monoclonal antibody isatuximab in multiple myeloma. Clin Cancer Res. 2019;25(10):3176–3187.
  • Van De Donk NW, Richardson PG, Malavasi F. CD38 antibodies in multiple myeloma: back to the future. Blood. 2018;131(1):13–29.
  • Cagnetta A, Cea M, Calimeri T, et al. Intracellular NAD+ depletion enhances bortezomib-induced anti-myeloma activity. Blood. 2013;122(7):1243–1255.
  • Fau JB, El‐Cheikh R, Brillac C, et al. Drug‐disease interaction and time‐dependent population pharmacokinetics of isatuximab in relapsed/refractory multiple myeloma patients. CPT Pharmacometrics Syst Pharmacol. 2020;9(11):649–658.
  • Sanofi-Aventis. Sarclisa© Full Prescribing Information. Reference ID. 4568826. In: New Jersey, USA. 2020.
  • Mei Z, Wool GD. Impact of novel monoclonal antibody therapeutics on blood bank pretransfusion testing. Hematol/Oncol Clin. 2019;33(5):797–811.
  • Quach H, Benson S, Haysom H, et al. Considerations for pre‐transfusion immunohaematology testing in patients receiving the anti‐CD38 monoclonal antibody daratumumab for the treatment of multiple myeloma. Intern Med J. 2018;48(2):210–220.
  • Mills JR, Kohlhagen MC, Willrich MA, et al. A universal solution for eliminating false positives in myeloma due to therapeutic monoclonal antibody interference. blood. 2018;132(6):670–672.
  • Deckert J, Wetzel M-C, Bartle LM, et al. SAR650984, a novel humanized CD38-targeting antibody, demonstrates potent antitumor activity in models of multiple myeloma and other CD38+ hematologic malignancies. Clin Cancer Res. 2014;20(17):4574–4583.
  • Jiang H, Acharya C, An G, et al. SAR650984 directly induces multiple myeloma cell death via lysosomal-associated and apoptotic pathways, which is further enhanced by pomalidomide. Leukemia. 2016;30(2):399–408.
  • Mikhael J, Richter J, Vij R, et al. A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma. InLeukemia. 2020;34(12):3298–3309.
  • Mikhael J, Richardson P, Usmani SZ, et al. A phase 1b study of isatuximab plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. Blood J Am Soc Hematol. 2019;134(2):123–133.
  • Dimopoulos MA, Leleu X, Moreau P, et al. Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis. Leukemia. 2021;35(2):562–572.
  • Krejcik J, Casneuf T, Nijhof IS, et al. Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016;128(3):384–394.
  • Adams III HC, Stevenaert F, Krejcik J, et al. High‐parameter mass cytometry evaluation of relapsed/refractory multiple myeloma patients treated with daratumumab demonstrates immune modulation as a novel mechanism of action. Cytometry Part A. 2019;95(3):279–289.
  • Chari A, Suvannasankha A, Fay JW, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017;130(8):974–981.
  • Siegel DS, Schiller GJ, Samaras C, et al. Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment. Leukemia. 2020;34(12):3286–3297.
  • Dimopoulos M, editor APOLLO: Phase 3 randomized study of subcutaneous daratumumab plus pomalidomide and dexamethasone (D-pd) versus pomalidomide and dexamethasone (pd) alone in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Abstract.
  • ClinicalTrials.gov. Comparison of pomalidomide and dexamethasone with or without daratumumab in subjects with relapsed or refractory multiple myeloma previously treated with lenalidomide and a proteasome inhibitor daratumumab/pomalidomide/dexamethasone vs pomalidomide/dexamethasone (EMN14). NCT03180736. [cited 2021 Jan 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT03180736.
  • Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319–1331.
  • Bahlis NJ, Dimopoulos MA, White DJ, et al. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended follow-up of POLLUX, a randomized, open-label, phase 3 study. Leukemia. 2020;34(7):1875–1884.
  • Weisel K, Spencer A, Lentzsch S, et al. Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk. J Hematol Oncol. 2020;13(1):1–11.
  • Moreau P, Attal M, Hulin C, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019;394(10192):29–38.
  • Voorhees PM, Kaufman JL, Laubach JP, et al.Daratumumab, lenalidomide, bortezomib, & dexamethasone for transplant-eligible newly diagnosed multiple myeloma: GRIFFIN. Blood. 2020;136(8):936–945.
  • Facon T, Kumar S, Plesner T, et al. Daratumumab plus lenalidomide and dexamethasone for untreated myeloma. N Engl J Med. 2019;380(22):2104–2115.
  • ClinicalTrials.gov. Multi-center, open-label, phase 1b study in patients with relapsed/refractory multiple myeloma (RRMM). [cited 2021 Jan 25]. Available from: https://clinicaltrials.gov/ct2/show/NCT04045795
  • Usmani SZ, Nahi H, Mateos M-V, et al. Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma. Blood. 2019;134(8):668–677.
  • San-Miguel J, Usmani SZ, Mateos M-V, et al. Subcutaneous daratumumab in patients with relapsed or refractory multiple myeloma: Part 2 of the open-label, multicenter, dose-escalation phase 1b study (PAVO). Haematologica. 2020. DOI: 10.3324/haematol.2019.243790.
  • Mateos M-V, Nahi H, Legiec W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. The lancet haematology. 2020;7(5):e370–e380.
  • ClinicalTrials.gov. Multinational clinical study comparing isatuximab, carfilzomib and dexamethasone to carfilzomib and dexamethasone in relapse and/or refractory multiple myeloma patients (IKEMA).
  • Thomas Martin JM, Hajek R, Kim K, et al. Depth of response and response kinetics of isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma: ikema interim analysis. Blood. 2020;136(Supplement 1):7–8.
  • Moreau P, Dimopoulos M, Mikhael J, et al. Isatuximab plus carfilzomib and dexamethasone vs carfilzomib and dexamethasone in relapsed/refractory multiple myeloma (IKEMA): interim analysis of a phase 3 randomized, open-label study. Hematol Transfus Cell Ther. 2020;42:262–263.
  • ClinicalTrials.gov. KRDI in transplant-eligible MM.
  • Becnel MR, Horowitz SB, Thomas SK, et al. Descriptive analysis of isatuximab use following prior daratumumab in patients with relapsed/refractory multiple myeloma. In: . BLOOD. WASHINGTON, DC 20036 USA: 2020:136 (Supplement 1): 20–21.

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