Dr. Richardson on First-In-Human Phase 1 Trial With CC-92480 in R/R Myeloma

Paul G. Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center; institute physician at Dana-Farber Cancer Institute; and RJ Corman Professor of Medicine at Harvard Medical School, discusses the patient population analyzed in the first-in-human phase 1 trial of the CELMoD CC-92480.

Of the 76 patients analyzed in this study, the median age was 66 years, with the oldest patient treated on the studyaged 78 years, says Richardson. Because this was a relapsed/refractory patient population, and these patients had received all other classes of drugs that are available to them with no success. Furthermore, the majority of patients enrolled on the study had International Staging System stage II and III disease, and 40% of patients had extramedullary disease, which is an indicator of poor prognosis, adds Richardson. Investigators also examined cytogenetics, although those data are currently pending.

What is very important with regard to this study, is that the median number of prior therapies was 6, but ranged between 2 and 13 prior therapies, says Richardson. The vast majority of these patients were refractory lenalidomide (Revlimid) and pomalidomide (Pomalyst), as well as to proteasome inhibition and CD38 monoclonal antibody therapy. Approximately 70% were refractory to monoclonal antibodies and 79% were refractory to pomalidomide. These numbers underscore how heavily pretreated the patient population was, says Richardson. In fact, more than half of the patients met the triple-class refractory criteria, making this a particularly poor-prognosis group, concludes Richardson.