IKEMA Update Reveals “Unprecedented” PFS in Relapsed Multiple Myeloma

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New data support isatuximab plus carfilzomib and dexamethasone (Isa-Kd) as standard care for relapsed multiple myeloma (MM), according to researchers. 

Updated data from the IKEMA trial showed that adding Isa to Kd significantly improved progression-free survival (PFS).

In fact, the “unprecedented” median PFS of 3 years is the longest PFS with a proteasome inhibitor backbone in the relapsed MM setting, according to Philippe Moreau, MD, of University Hospital Hôtel-Dieu in Nantes, France.


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Dr Moreau presented these findings during a recent ESMO Virtual Plenary session. 

The phase 3 IKEMA trial (ClinicalTrials.gov Identifier: NCT03275285) enrolled 302 patients with relapsed MM; 179 were randomly assigned to Isa-Kd and 123 to Kd. Baseline characteristics were well balanced between the treatment arms. 

At a median follow-up of 44 months, 49 patients (27.4%) in the Isa-Kd group and 11 patients (8.9%) in the Kd group were still on study treatment. 

The primary endpoint was PFS. The median PFS was 35.7 months in the Isa-Kd arm and 19.2 months in the Kd arm (hazard ratio [HR], 0.58; 95.4% CI, 0.42-0.79). The PFS benefit with Isa-Kd was consistent across subgroups, including among patients with high-risk cytogenetics and those who were refractory to lenalidomide. 

Isa-Kd also delayed the time to next treatment and prolonged PFS2. The median time to next treatment was 25.0 months with Kd and 44.9 months with Isa-Kd (HR, 0.55; 95% CI, 0.40-0.76). The median PFS2 was 35.6 months and 47.2 months, respectively (HR, 0.68; 95% CI, 0.50-0.94).

The researchers also assessed response and minimal residual disease (MRD). The rate of complete response (CR) or stringent CR was 44.1% in the Isa-Kd group and 28.5% in the Kd group. 

MRD negativity was achieved in 33.5% of patients in the Isa-Kd group and 15.4% in the Kd group. The rate of MRD negativity among patients with a CR or stringent CR was 26.3% in the Isa-Kd group and 12.2% in the Kd group. 

Serious treatment-emergent adverse events (TEAEs) were reported in 70.1% of patients in the Isa-Kd group and 59.8% in the Kd group. Fatal TEAEs occurred in 5.6% and 4.9% of patients, respectively.

Dr Moreau noted that safety findings were consistent with the prior interim analysis results, and the addition of Isa to Kd did not increase fatal TEAEs or events leading to discontinuation. 

Disclosures: This research was supported by Sanofi. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Moreau P, Dimopoulos MA, Mikhael J, et al. VP5-2022: Updated progression-free survival (PFS) and depth of response in IKEMA, a randomized phase III trial of isatuximab, carfilzomib and dexamethasone (Isa-Kd) vs Kd in relapsed multiple myeloma (MM).  ESMO Virtual Plenary. May 19-20, 2022. doi:https://doi.org/10.1016/j.annonc.2022.04.013



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