medigraphic.com

2022, Number 3

<< Back Next >>

Rev Hematol Mex 2022; 23 (3)

Isatuximab, a new benchmark in resistant multiple myeloma; pre-launch experience in Mexico

Ramírez-Alvarado A, Deffis-Court M, Pineda-Hernández I

Language: Spanish
References: 22
Page: 213-221
PDF size: 242.83 Kb.


ABSTRACT

Background: Multiple myeloma is the second most prevalent hematologic neoplasm; it is characterized by damage to multiple organ systems, which leads to reduced quality of life, as well as shortened patient survival. Although many therapeutic options currently exist, multiple myeloma is associated with frequent relapses, which in turn lead to the disease becoming refractory to treatments, progressively complicating patient management and leading to complications, both of the disease as well as of treatmentassociated adverse effects, and ultimately to patient death. Currently, one of the most promising therapeutic options are the anti-CD38 monoclonal antibodies, which have demonstrated considerable benefits in clinical trials, and which, when combined with other agents, have proven benefits on progression free survival and on disease control.
Clinical cases: This paper reports the first experiences with isatuximab in Mexican patients with relapsed/refractory multiple myeloma. Isatuximab adds itself to current therapeutic options in the search for better survival outcomes and quality of life in persons with this disease.
Conclusions: Isatuximab is added to the existing therapeutic options in the search for greater survival and better quality of life for people with multiple myeloma.


REFERENCES

  1. Kazandjian D. Multiple myeloma epidemiology and survival,a unique malignancy. Semin Oncol 2016; 43 (6): 676-681.doi: 10.1053/j.seminoncol.2016.11.004.

  2. Richardson PG, Beksaç M, Špičkac I, Mikhael J. Isatuximabfor the treatment of relapsed/refractory multiple myeloma.Expert Opin Biol Ther 2020; 20: 1395-1404. doi: 10.2217/fon-2021-0568.

  3. Cowan AJ, Allen C, Barac A, Basaleem H, Bensenor I,Curado MP, et al. Global Burden of Multiple Myeloma. ASystematic Analysis for the Global Burden of Disease Study2016. JAMA Oncol 2018; 4 (9): 1221-1227. doi: 10.1001/jamaoncol.2018.2128.

  4. Espinoza-Zamora JR, Figueroa-Acosta R, Ledesma-OsorioYC. La carga del mieloma múltiple en México: una investigaciónepidemiológica del Sistema Nacional deSalud. Gac Mex Oncol 2020; 19 (4): 135-142. https://doi.org/10.24875/j.gamo.19000281.

  5. Gómez-Dantés H, Lamadrid-Figueroa H, Cahuana-HurtadoL, Silverman-Retana O, Montero P, González-Robledo MC,et al. The burden of cancer in Mexico, 1990-2013. SaludPublica Mex 2016; 58 (2): 118-31.

  6. Kumar SK, Rajkumar V, Kyle RA, Van Duin M, Sonneveld P,Mateos MV, et al. Multiple myeloma. Nat Rev Dis Primers2017; 3: article 17046. doi: 10.1038/nrdp.2017.46.

  7. Rajkumar SV. Multiple myeloma: 2020 update on diagnosis,risk-stratification and management. Am J Hematol 2020;95: 548-567. doi: 10.1002/ajh.25791.

  8. Attal M, Richardson PG, Rajkumar SV, San Miguel J, BeksacM, Spicka I, et al. Isatuximab plus pomalidomideand low-dose dexamethasone versus pomalidomide andlow-dose dexamethasone in patients with relapsed andrefractory multiple myeloma (ICARIA-MM): a randomised,multicentre, open-label, phase 3 study. Lancet 2019; 394:2096-2107. doi: 10.1016/S0140-6736(19)32556-5.

  9. Lonial S, Weiss BM, Usmani SZ, Singhal S, Chari A, BahlisNJ, et al. Daratumumab monotherapy in patients withtreatment-refractory multiple myeloma (SIRIUS): anopen-label, randomised, phase 2 trial. Lancet 2016; 387:1551-60. doi: 10.1016/S0140-6736(15)01120-4.

  10. Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ,Usmani SZ, et al. Daratumumab, lenalidomide, and dexamethasonefor multiple myeloma. N Engl J Med 2016; 375:1319-1331. DOI: 10.1056/NEJMoa1607751.

  11. Chari A, Suvannasankha A, Fay JW, Arnulf B, Kaufman JL,Ifthikharuddin JJ, et al. Daratumumab plus pomalidomideand dexamethasone in relapsed and/or refractory multiplemyeloma. Blood 2017; 130: 974-981. doi: 10.1182/blood-2017-05-785246.

  12. Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, MassziT, Beksac M, et al. Daratumumab, bortezomib, and dexamethasonefor multiple myeloma. N Engl J Med 2016; 375:754-766. DOI: 10.1056/NEJMoa1606038.

  13. Moreau P, Dimopoulos MA, Mikhael J, Yong K, et al. Isatuximab,carfilzomib, and dexamethasone in relapsed multiplemyeloma (IKEMA): a multicentre, open-label, randomisedphase 3 trial. Lancet 2021; 397: 2361-2371. doi: 10.1016/S0140-6736(21)00592-4.

  14. Darzalex, Indicaciones para prescribir; en https://www.medicamentosplm.com/Home/productos/darzalex_solucion/84/101/65407/146, revisado el 2 de noviembrede 2021

  15. Diario Oficial de la Federación (SEGOB); Décimo SegundaActualización de la Edición 2020 del Libro de Medicamentosdel Compendio Nacional de Insumos para la Salud; enhttps://www.dof.gob.mx/nota_detalle.php?codigo=5611499&fecha=15/02/2021, revisado el 2 de noviembre de 2021

  16. US Food and Drug Administration: FDA approves isatuximab-irfc for multiple myeloma; en https://www.fda.gov/drugs/resources-information-approved-drugs/fdaapproves-isatuximab-irfc-multiple-myeloma, revisado el2 de noviembre de 2021

  17. US Food and Drug Administration: FDA approves isatuximab-irfc for multiple myeloma; en https://www.fda.gov/drugs/resources-information-approved-drugs/fdaapproves-isatuximab-irfc-multiple-myeloma-0, revisadoen 8 de noviembre de 2021

  18. European Medicines Agency: Sarclisa; en https://www.ema.europa.eu/en/medicines/human/EPAR/sarclisa,revisado el 2 de noviembre de 2021

  19. Van de Donk NWCJ, Usmani SZ. CD38 antibodies inmultiple myeloma: mechanisms of action and modes ofresistance. Front Immunol 2018; 9: 2134. doi: 10.3389/fimmu.2018.02134.

  20. Zanetti BA, Corso Faini A, Massari E, Geuna M, Maffini E,Poletti G, et al. Novel insights in anti-CD38 therapy basedon CD38-receptor expression and function: The multiplemyeloma model. Cells 2020; 9: 2666. doi:10.3390/cells9122666.

  21. Bonello F, D’Agostino M, Moscvin M, Cerrato C, BoccadoroM, Gay F. CD38 as an immunotherapeutic target in multiplemyeloma. Expert Opin Biol Ther 2018; 18: 1209-1221.https://doi.org/10.1080/14712598.2018.1544240.

  22. Mikhael J, Belhadj-Merzoug K, Hulin C, Vincent L, MoreauP, Gasparetto C, et al. A phase 2 study of isatuximabmonotherapy in patients with multiple myeloma who arerefractory to daratumumab. Blood Cancer J 2021; 11: 89.https://doi.org/10.1038/s41408-021-00478-4.




2020     |     www.medigraphic.com