In the IKEMA trial, researchers compared carfilzomib and dexamethasone plus isatuximab against carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma (MM). Updated data were published in Clinical Lymphoma, Myeloma & Leukemia, wherein researchers showed that treatment with isatuximab yielded with clinically meaningful improvements in duration of response (DOR) compared to treatment without isatuximab.
The phase 3, open-label IKEMA trial enrolled patients with relapsed MM after 1 to 3 prior lines of treatment. Researchers administered intravenous isatuximab 10 mg/kg QW for 4 weeks, followed by Q2W to the treatment arm. Both the treatment and control arm received intravenous carfilzomib and oral/intravenous dexamethasone. The primary end point of the study was progression-free survival (PFS), while additional endpoints included complete response (CR) and minimal residual disease (MRD) measures.
Isatuximab Appears Effective in Relapsed MM
According to the investigators, over a median follow-up period of 44 months by the January 2022 data cutoff, patients in the isatuximab with carfilzomib and dexamethasone group achieved deeper responses compared to patients in the carfilzomib and dexamethasone group, with ≥CR rates of 44.1% versus 28.5%, respectively (odds ratio [OR], 2.09; 95% CI, 1.26-3.48; P=.0021).
Likewise, MRD- occurred in 33.5% of isatuximab, carfilzomib and dexamethasone patients versus 15.4% of carfilzomib and dexamethasone patients (OR, 2.78; 95% CI, 1.55-4.99; P=.0002). Overall, 26.3% of the isatuximab group achieved both ≥CR and MRD- compared with 12.2% in the control group (OR, 2.57; 95% CI, 2.35-4.88; P=.0015). Isatuximab also appeared to improve outcomes for MRD+ patients.
In closing, the authors highlighted that the “impressive ≥CR and ≥CR+MRD- (10-5) rates in Isa-Kd versus Kd are the highest reported for proteasome inhibitor-based regimens in relapsed MM. Achieving MRD- led to better outcomes in both arms; Isa-Kd patients had >2-fold higher likelihood of achieving MRD-.”