Isa-EloPD is Safe and Feasible in R/R Multiple Myeloma
Binod Dhakal, MD, MS, discusses the safety data from the phase 2 IMPEDE study of isatuximab, pomalidomide, elotuzumab, and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma.
Binod Dhakal, MD, MS, assistant professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, discusses the safety data from the phase 2 IMPEDE study (NCT04835129) of isatuximab (Sarclisa), pomalidomide (Pomalyst), elotuzumab (Empliciti), and dexamethasone (Isa-EloPD) for the treatment of patients with relapsed/refractory multiple myeloma.
A total of 15 patients were enrolled who had a median age of 68 years (range, 54-79). Three of these patients were African American, all patients had disease that was refractory to lenalidomide, 3 patients were refractory to both bortezomib (Velcade) and lenalidomide (Revlimid), and 6 were previously exposed to an anti-CD38 monoclonal antibody.
At a median follow-up of 8.5 months (range, 1-16.6), none of the patients in the lead-in phase of the study experienced a dose-limiting toxicity. All patients had a grade 3-4 treatment-emergent adverse event (TEAE), and the most commonly reported were lymphopenia (93%), neutropenia (93%) and leukopenia (40%). One patient (7%) had a grade 3-4 infection and no patients had a grade 5 TEAE. Additionally, only 1 patient had an infusion-related reaction.
Transcription:
0:09 | As of the data cutoff that was presented at ASH [the American Society of Hematology 2023 Annual Meeting], there were 15 patients, and that includes 6 patients in the safety lead-in. If we look at the overall patient population, the median age was 68 years, which is pretty standard for the myeloma patient, ranging from 54 to 79. All patients were lenalidomide-refractory and had prior use of an anti-CD38 antibody, mainly daratumumab (Darzalex) was used in 6 patients. About 73% of patients had evidence of high-risk cytogenetics. As I mentioned before, all 6 patients completed the safety lead-in phase. We were able to go to the expansion phase, which means that they must have completed at least 2 cycles of the treatment. In those 6 patients who completed at least 2 cycles, we did not observe any dose-limiting toxicities, which is pretty good.
0:59 | In terms of the overall patient population, the grade 3/4 treatment-emergent adverse events we saw in all 15 patients were mainly the hematological adverse events of lymphopenia at 93%, neutropenia at 93%, and leukopenia at 40%, which are pretty manageable with either a dose reduction, a dose delay, or with the growth factor support. Grade 3/4 infection was seen in 1 patient. That was mainly complicated by RSV infection, so it is very difficult to say whether it is related to the combination because the patient had exposure. Infusion-related reaction was of concern with a combination of 2 different monoclonal antibodies, but we were only able to 1 patient, and that was also maximum of grade 2.
