Isa-EloPD is Safe and Feasible in R/R 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.

REFERENCE

Dhakal B, Mohan M, Narra R, et al. Dual targeting of slamf-7 and CD38 in multiple myeloma (MM): A phase II study of isatuximab, elotuzumab, pomalidomide and dexamethasone (Isa-EloPD) in relapsed and/or refractory MM (RRMM). Presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition; December 9-12; San Diego, CA; 3379.