Adding elotuzumab to carfilzomib, lenalidomide, and dexamethasone (KRd) leads to deeper remissions in transplant-eligible patients with newly diagnosed multiple myeloma, according to research presented at the ASCO Annual Meeting 2023.
Researchers found that patients who received elotuzumab plus KRd had a higher rate of very good partial response (VGPR) or better with minimal residual disease (MRD) negativity, when compared to patients who received KRd only.
This is the first study to show a positive impact of elotuzumab in the first-line setting, said study presenter Stefan Knop, MD, of Wuerzburg University Medical Center in Germany.
In this phase 3 study (ClinicalTrials.gov Identifier: NCT03948035), 579 patients with transplant-eligible, newly diagnosed multiple myeloma were randomly assigned to receive elotuzumab plus KRd (n=291) or KRd (n=288). Baseline characteristics were well balanced between the arms.
Patients received 6 cycles of KRd with or without elotuzumab (with chemomobilization after cycle 3 in both arms). Patients with stable disease or better underwent autologous stem cell transplant with high-dose melphalan, then received 4 cycles of KRd with or without elotuzumab. This was followed by maintenance with elotuzumab-lenalidomide or lenalidomide alone.
At the data cutoff, 91.6% of patients had completed all 6 induction cycles. The proportion of patients who achieved a VGPR or better and MRD negativity was 49.8% in the elotuzumab arm and 35.4% in the KRd-only arm (P =.0005).
The rate of MRD negativity alone was 52.6% in the elotuzumab arm and 37.5% in the KRd-only arm (P =.0003). Among MRD-negative patients, the rate of VGPR was 28.9% and 13.5%, respectively. The rate of complete response was 14.8% and 14.2%, respectively. The rate of stringent complete response was 6.1% and 7.6%, respectively.
The safety analysis included 574 patients. Grade 3 or higher adverse events (AEs) occurred in 74.7% of patients treated with elotuzumab plus KRd and 66.3% of patients treated with KRd only. There were 5 fatal AEs in the elotuzumab arm and 8 in the KRd-only arm.
A total of 21 patients had confirmed COVID-19. Four patients had grade 3/4 COVID-19, and 2 patients died from COVID-19.
Follow-up is ongoing for progression-free survival and other time-dependent endpoints, Dr Knop said.
Disclosures: This research was supported by Amgen, Celgene, and Bristol Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Knop S, Stuebig T, Kull M, et al. Carfilzomib, lenalidomide, and dexamethasone (KRd) versus elotuzumab and KRd in transplant-eligible patients with newly diagnosed multiple myeloma: Post-induction response and MRD results from an open-label randomized phase 3 study. ASCO 2023. June 2-6, 2023. Abstract 8000.
This article originally appeared on Cancer Therapy Advisor