874
Views
1
CrossRef citations to date
0
Altmetric
Drug Safety Evaluation

Efficacy and safety of elotuzumab for the treatment of multiple myeloma

, , &
Pages 237-245 | Received 11 Oct 2016, Accepted 04 Jan 2017, Published online: 11 Jan 2017

References

  • Kumar S, Rajkumar S, Dispenzieri A, et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood. 2008;111:2516–2520.
  • Attal M, Harousseau J, Stoppa A, et al. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Français du Myélome. N Engl J Med. 1996;335:91–97.
  • Palumbo A, Bringhen S, Bertola A, et al. Multiple myeloma: comparison of two dose-intensive melphalan regimens [100 versus 200 mg/m (2)]. Leukemia. 2004;18:133–138.
  • Palumbo A, Cavallo F, Gay F, et al. Autologous transplantation and maintenance therapy in multiple myeloma. N Engl J Med. 2014;371:895–905.
  • Gay F, Oliva S, Petrucci M, et al. Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase III trial. Lancet Oncol. 2015;16:1617–1629.
  • El-Amm J, Tabbara IA. Emerging therapies in multiple myeloma. Am J Clin Oncol. 2015;38(3):315–321. DOI:10.1097/COC.0b013e3182a4676b
  • Dimopoulos M, Richardson P, Moreau P, et al. Current treatment landscape for relapsed and/or refractory multiple myeloma. Nat Rev Clin Oncol. 2015b;12:42–54.
  • Lonial S, Durie B, Palumbo A, et al. Monoclonal antibodies in the treatment of multiple myeloma: current status and future perspectives. Leukemia. 2016;30(3):526–535.
  • Liu Y, Szmania S, van Rhee F. Profile of elotuzumab and its potential in the treatment of multiple myeloma. Blood Lymphat Cancer. 2014;2014:15–27.
  • Veillette A, Guo H. CS1, a SLAM family receptor involved in immune regulation, is a therapeutic target in multiple myeloma. Crit Rev Oncol Hematol. 2013;88(1):168–177.
  • Shaughnessy JD, Zhan F, Burington BE, et al. A validated gene expression model of high-risk multiple myeloma is defined by deregulated expression of genes mapping to chromosome 1. Blood. 2007;109(6):2276–2284.
  • Veillette A. SLAM-family receptors: immune regulators with or without SAP-family adaptors. Cold Spring Harb Perspect Biol. 2010;2:a002469.
  • Cannons J, Tangye S, Schwartzberg P. SLAM family receptors and SAP adaptors in immunity. Annu Rev Immunol. 2011;29:665–705.
  • Tai Y, Dillon M, Song W, et al. Anti-CS1 humanized monoclonal antibody HuLuc63 inhibits myeloma cell adhesion and induces antibody-dependent cellular cytotoxicity in the bone marrow milieu. Blood. 2008;112:1329–1337.
  • Tai YT, Soydan E, Song W, et al. CS1 promotes multiple myeloma cell adhesion, clonogenic growth, and tumorigenicity via c-maf-mediated interactions with bone marrow stromal cells. Blood. 2009;113(18):4309–4318. DOI:10.1182/blood-2008-10-183772
  • Cruz-Munoz ME, Dong Z, Shi X, et al. Influence of CRACC, a SLAM family receptor coupled to the adaptor EAT-2, on natural killer cell function. Nat Immunol. 2009;10(3):297–305. DOI:10.1038/ni.1693
  • Hsi ED, Steinle R, Balasa B, et al. CS1, a potential new therapeutic antibody target for the treatment of multiple myeloma. Clin Cancer Res. 2008;14(9):2775–2784. DOI:10.1158/1078-0432.CCR-07-4246
  • van Rhee F, Szmania S, Dillon M, et al. Combinatorial efficacy of anti-CS1 monoclonal antibody elotuzumab (HuLuc63) and bortezomib against multiple myeloma. Mol Cancer Ther. 2009;8:2616–2624.
  • Perez-Quintero L, Roncagalli R, Guo H, et al. EAT-2, a SAP-like adaptor, controls NK cell activation through phospholipase Cγ, Ca++, and Erk, leading to granule polarization. J Exp Med. 2014;211:727–742.
  • Clarkson N, Brown M. Inhibition and activation by CD244 depends on CD2 and phospholipase C-gamma1. J Biol Chem. 2009;284:24725–24734.
  • Collins S, Bakan C, Swartzel G, et al. Elotuzumab directly enhances NK cell cytotoxicity against myeloma via CS1 ligation: evidence for augmented NK cell function complementing ADCC. Cancer Immunol Immunother. 2013;62:1841–1849.
  • Roncagalli R, Taylor J, Zhang S, et al. Negative regulation of natural killer cell function by EAT-2, a SAP-related adaptor. Nat Immunol. 2005;6:1002–1010.
  • Jakubowiak A, Offidani M, Pégourie B, et al. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016;127(23):2833–2840.
  • Kim J, Mathew S, Patel R, et al. Altered expression of signalling lymphocyte activation molecule (SLAM) family receptors CS1 (CD319) and 2B4 (CD244) in patients with systemic lupus erythematosus. Clin Exp Immunol. 2010;160:348–358.
  • Neyer L, Ding H, Chen D, et al. Effect of elotuzumab on circulating lymphocytes, chemokines, and cytokines in multiple myeloma patients. Blood. 2010;116:4070.
  • Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373:621–631.
  • Lee J, Boles K, Mathew P. Molecular and functional characterization of a CS1 (CRACC) splice variant expressed in human NK cells that does not contain immunoreceptor tyrosine-based switch motifs. Eur J Immunol. 2004;34:2791–2799.
  • Balasa B, Yun R, Belmar N, et al. Elotuzumab enhances natural killer cell activation and myeloma cell killing through interleukin-2 and TNF-α pathways. Cancer Immunol Immunother. 2015;64:61–73.
  • Zonder J, Mohrbacher A, Singhal S, et al. A phase I, multicenter, open-label, dose escalation study of elotuzumab in patients with advanced multiple myeloma. Blood. 2012;120:552–559.
  • Jakubowiak A, Benson D, Bensinger W, et al. Phase I trial of anti-CS1 monoclonal antibody elotuzumab in combination with bortezomib in the treatment of relapsed/refractory multiple myeloma. J Clin Oncol. 2012;30:1960–1965.
  • Lonial S, Vij R, Harousseau J, et al. Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma. J Clin Oncol. 2012;30:1953–1959.
  • Richardson P, Jagannath S, Moreau P, et al. Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma: final phase II results from the randomised, open-label, phase Ib-2 dose-escalation study. Lancet Haematol. 2015;2:e516–527.
  • Mateos MV, Granell M, Oriol A, et al. Elotuzumab in combination with thalidomide and low-dose dexamethasone: a phase 2 single-arm safety study in patients with relapsed/refractory multiple myeloma. Br J Haematol. 2016 Nov;175(3):448–456.
  • Dimopoulos M, Lonial S, White D, et al. ELOQUENT-2 update: a phase III, randomized, open-label study of elotuzumab in combination with lenalidomide/dexamethasone in patients with relapsed/refractory multiple myeloma – 3-year safety and efficacy follow-up. Blood. 2015a;126:28.
  • Usmani SZ, Sexton R, Ailawadhi S, et al. Phase I safety data of lenalidomide, bortezomib, dexamethasone, and elotuzumab as induction therapy for newly diagnosed symptomatic multiple myeloma: SWOG S1211. Blood Cancer J. 2015;5:e334. DOI: 10.1038/bcj.2015.62.
  • Quach H, Ritchie D, Stewart AK, et al. Mechanism of action of immunomodulatory drugs (IMiDS) in multiple myeloma. Leukemia. 2010;24(1):22–32.
  • 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.
  • Berdeja J, Jagannath S, Zonder J, et al. Pharmacokinetics and safety of elotuzumab combined with lenalidomide and dexamethasone in patients with multiple myeloma and various levels of renal impairment: results of a phase Ib study. Clin Lymphoma Myeloma Leuk. 2015;16:129–138.
  • Durie BG, Harousseau JL, Miguel JS, et al. International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006;20(9):1467–1473.
  • Ludwig H, Miguel JS, Dimopoulos MA, et al. International Myeloma Working Group recommendations for global myeloma care. Leukemia. 2014;28(5):981–992.
  • van de Donk NWCJ, Kamps S, Mutis T, et al. Monoclonal antibody-based therapy as a new treatment strategy in multiple myeloma. Leukemia. 2012;26(2):199–213.
  • Allegra A, Penna G, Alonci A, et al. Monoclonal antibodies: potential new therapeutic treatment against multiple myeloma. Eur J Haematol. 2013;90(6):441–468.
  • Tai Y-T, Anderson KC. Antibody-based therapies in multiple myeloma. Bone Marrow Res. 2011;2011:924058. doi: 10.1155/2011/924058. Epub 2011 Mar 2.
  • Richardson PG, Lonial S, Jakubowiak AJ, et al. Monoclonal antibodies in the treatment of multiple myeloma. Br J Haematol. 2011;154(6):745–754.
  • ClinicalTrials.gov. A Phase I open label study of the safety and tolerability of elotuzumab (BMS-901608) administered in combination with either lirilumab (BMS-986015) or urelumab (BMS-663513) in subject with multiple myeloma (Study 028). NCT02252263. 2015 [cited 2016 Mar 4].
  • ClinicalTrials.gov. Japanese study of (BMS-901608) (elotuzumab) in combination with lenalidomide and low dose dexamethasone. NCT01241292. 2015 [cited 2016 Mar 4].
  • ClinicalTrials.gov. Elotuzumab in autologous stem cell transplantation (ASCT) and lenalidomide maintenance for multiple myeloma. NCT02655458. 2016 [cited 2016 Mar 4].
  • ClinicalTrials.gov. Study of elotuzumab with lenalidomide as maintenanceafter autologous stem cell transplant (ASCT). NCT02420860. 2015 [cited 2016 Mar 4].
  • ClinicalTrials.gov. Study of bortezomib, lenalidomide, dexamethasone & elotuzumab in newly diagnosed MM. NCT02375555. 2015 [cited 2016 Mar].
  • ClinicalTrials.gov. Safety study of elotuzumab in combination with thalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. NCT01632150. 2015 [cited 2016 Mar 4].
  • ClinicalTrials.gov. Trial of elotuzumab with or without pomalidomideand low-dose dexamethasone to treat refractory and relapsed and refractory multiple myeloma. NCT02654132. 2015 [cited 2016 Feb 2].
  • ClinicalTrials.gov. A study of Elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd) in patients with multiple myeloma relapsed or refractory to prior treatment with lenalidomide (Study 142) (NCT02612779). NCT02612779. 2015 [cited 2016 Mar 4].
  • ClinicalTrials.gov. Biomarker study of elotuzumab in high risk smolderingmyeloma. NCT01441973. 2015 [cited 2016 Mar 4].
  • ClinicalTrials.gov. Trial of combination of elotuzumab and lenalidomide± dexamethasone in high-risk smoldering multiple myeloma. NCT02279394. 2015 [cited 2016. Mar 4].
  • ClinicalTrials.gov. PH III study of lenalidomide and dexamethasonewith and without elotuzumab to treat previously untreated multiplemyeloma (ELO 1 Sub study). NCT01891643. 2015 [cited 2016 Mar 4].
  • ClinicalTrials.gov. A Phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed multiple myeloma (GMMG-HD6). NCT02495922. 2015 [cited 2016 Mar 4].
  • ClinicalTrials.gov. Study of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Multiple Myeloma (CheckMate 602) (NCT02726581). NCT02726581. 2016 [cited 2016 Apr 6].

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.