Isatuximab Combo Improved PFS in Relapsed Multiple Myeloma

Isatuximab combined with carfilzomib and dexamethasone significantly improved median progression-free survival (PFS) in patients with relapsed multiple myeloma (MM) compared with carfilzomib and dexamethasone alone, according to data from the phase III IKEMA trial.

The median PFS with the three-drug combination was 35.7 months compared with 19.2 months with carfilzomib and dexamethasone alone (hazard ratio [HR]=0.58; 95% CI, 25.8-44.0). Sanofi, the manufacturer of isatuximab, announced these results ahead of the European Society for Medical Oncology meeting.

“The increase in PFS, observed consistently across all subgroups, when adding [isatuximab] to carfilzomib and dexamethasone is remarkable in patients with relapsed MM in a proteasome inhibitor combination,” Philippe Moreau, MD, Head of the Department of Hematology, University Hospital of Nantes, France, said in a press release. “This updated analysis reinforces the potential for [isatuximab] to become a new standard of care for patients with relapsed MM.”

The trial enrolled 302 patients with relapsed MM who were randomized to receive isatuximab plus carfilzomib plus dexamethasone or carfilzomib plus dexamethasone alone. All participants had received one to three prior anti-myeloma therapies.

Time to next treatment for patients in the isatuximab combination cohort was 44.9 months (HR=0.55; 95% CI, 31.6-not calculable) versus 25.0 months for those receiving carfilzomib plus dexamethasone alone (95% CI, 17.9-31.3). Time to next treatment measured the interval from the date of randomization to the date of commencement of the next line of therapy, thereby allowing for measurement of the period of therapeutic benefit.

For the isatuximab combination therapy and carfilzomib plus dexamethasone alone groups, the most common adverse events were infusion-related reaction (45.8% vs 3.3%), diarrhea (39.5% vs 32%), hypertension (37.9% vs 35.2%), upper respiratory tract infection (37.3% vs 27%), fatigue (31.6% vs 20.5%), dyspnea (30.5% vs 22.1%), pneumonia (27.1% vs 21.3%), back pain (25.4% vs 21.3%), insomnia (25.4% vs 24.6%), and bronchitis (24.3% vs 12.3%).

The majority of patients in both arms experienced grade ≥3 treatment-emergent adverse events. Serious treatment-emergent adverse events occurred more frequently in the isatuximab group (70.1% vs 59.8%).

Source: Sanofi Press Release, May 2022