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Monoterapia con daratumumab en pacientes con mieloma múltiple refractario al tratamiento (SIRIUS): ensayo abierto,

Sagar Lonial¹, Brendan M Weiss², Saad Z Usmani³

¹Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.

Lancet (London, England)

|January 19, 2016

Resumen

La monoterapia con daratumumab demostró una eficacia alentadora en pacientes con mieloma múltiple refractario, mostrando un perfil de seguridad favorable. Este nuevo anticuerpo dirigido a CD38 ofrece una nueva esperanza para las personas fuertemente pretratadas.

Área de la Ciencia:

Hematología
En el campo de la oncología
La inmunoterapia

Sus antecedentes:

Los pacientes con mieloma múltiple refractarios a los inhibidores del proteasoma y los fármacos inmunomoduladores requieren nuevas opciones de tratamiento.
Daratumumab, un anticuerpo monoclonal dirigido a CD38, fue investigado para su eficacia en esta población de pacientes.

Objetivo del estudio:

Evaluar la eficacia y seguridad de daratumumab en monoterapia en pacientes con mieloma múltiple recidivante o refractario.
Para determinar la dosis óptima de daratumumab para otros ensayos clínicos.

Principales métodos:

Un ensayo abierto, multicéntrico, de fase 2 en el que participaron pacientes con mieloma múltiple refractario.
Los pacientes fueron asignados al azar para recibir daratumumab por vía intravenosa en dosis de 8 mg/ kg o 16 mg/ kg.
El criterio de valoración primario fue la tasa de respuesta global (TRG).

Principales resultados:

En 106 pacientes que recibieron 16 mg/ kg de daratumumab, el ORR fue del 29,2% (IC del 95% 20,8- 38,9).
La mediana de duración de la respuesta fue de 7,4 meses y la mediana de supervivencia libre de progresión fue de 3,7 meses.
Daratumumab fue bien tolerado, siendo la fatiga y la anemia las reacciones adversas más comunes; no se informó de interrupciones del tratamiento debido a reacciones adversas.

Conclusiones:

La monoterapia con daratumumab demostró una eficacia alentadora en pacientes con mieloma múltiple fuertemente pretratado y refractario.
El medicamento exhibió un perfil de seguridad favorable en esta población de pacientes desafiantes.

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