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Adding isatuximab to carfilzomib and dexamethasone (Kd) does not significantly improve overall survival (OS) in patients with relapsed or refractory multiple myeloma, according to the final survival analysis from the IKEMA trial.
The data did show, however, that time to next treatment and second progression-free survival (PFS2) were better with isatuximab-Kd, “demonstrating a sustained isatuximab benefit through the subsequent line of treatment,” said study presenter Philippe Moreau, MD, of the University Hospital of Nantes in France.
Dr Moreau presented these results at the International Myeloma Society Annual Meeting 2023.
The phase 3 IKEMA trial (ClinicalTrials.gov identifier: NCT03275285) enrolled 302 patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy. The patients were randomly assigned to receive isatuximab-Kd (n=179) or Kd (n=123). Patients were treated until progressive disease, unacceptable toxicity, or patient withdrawal.
The primary endpoint was PFS, which was previously reported at a median follow-up of 43.96 months. At that time, the median PFS was 35.7 months with isatuximab-Kd and 19.2 months with Kd (hazard ratio [HR], 0.58; 99% CI, 0.42-0.79).
The median follow-up for the current analysis was 56.61 months. At the time of data cutoff, 23.5% of patients in the isatuximab-Kd arm and 5.7% in the Kd arm were still on study treatment.
The median OS was not yet reached with isatuximab-Kd and was 50.6 months with Kd (HR, 0.855; 95% CI, 0.608-1.202; P =.1836). This trend was consistent across major subgroups. However, COVID-19 disproportionately impacted OS in the isatuximab-Kd arm. There were 8 deaths from COVID-19 in the isatuximab-Kd arm and 2 COVID-19 deaths in the Kd arm.
“Extrapolating the current trend for overall survival in the triplet arm, we can estimate that the median OS will be roughly 63 months, so there is a 1-year difference of overall survival when comparing the 2 arms,” Dr Moreau noted.
The median time to next treatment was 43.99 months in the isatuximab-Kd arm and 25.0 months in the Kd arm (HR, 0.583; 95% CI, 0.429-0.792; P =.0002).
The proportion of patients who received an anti-CD38 agent as subsequent treatment was 29.2% in the isatuximab-Kd arm and 63.0% in the Kd arm. The proportion of patients who received anti-BCMA therapy was 20.2% and 6.2%, respectively.
The median PFS2 was 47.18 months in the isatuximab-Kd arm and 32.36 months in the Kd arm (HR, 0.663; 95% CI, 0.491-0.895; P =.0035).
There were no new safety signals in either treatment arm. The rate of grade 3 or higher treatment-emergent adverse events (TEAEs) was 84.2% in the isatuximab-Kd arm and 73.0% in the Kd arm.
Treatment discontinuation due to TEAEs occurred in 13.6% of patients in the isatuximab-Kd arm and 18.0% of those in the Kd arm. The incidence of cardiac failure was 8.5% and 8.2%, respectively.
Disclosures: This study was supported by Sanofi. The study authors declared affiliations with Sanofi and many other companies.
Reference
Yong K, Martin T, Dimopoulos M, et al. Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed multiple myeloma (IKEMA): Final overall survival analysis. Presented at IMS 2023. September 27-30, 2023. Abstract OA-48.
This article originally appeared on Cancer Therapy Advisor
