Dr Lonial on the Outcomes of the IKEMA Trial in Relapsed Multiple Myeloma

Sagar Lonial, MD, FACP, chief medical officer, professor, chair, Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Anne and Bernard Gray Family Chair in Cancer, Emory University School of Medicine, discusses the final overall survival (OS) analysis of the phase 3 IKEMA trial (NCT03275285) of isatuximab-irfc (Sarclisa) when combined with carfilzomib (Kyprolis) and dexamethasone in patients with relapsed multiple myeloma, highlighting the progression-free survival (PFS) and OS outcomes.

Information from the phase 3 trial was presented at the 2023 International Myeloma Society Annual Meeting. The IKEMA trial was a randomized study investigating the efficacy of isatuximab, a CD38 inhibitor, when combined with carfilzomib, a proteasome inhibitor, and dexamethasone compared with carfilzomib and dexamethasone alone, Lonial begins. This trial enrolled patients with relapsed myeloma who have undergone 1 to 3 prior lines of therapy, he states.

The primary end point of the IKEMA study was PFS, and key secondary end points included overall response rate, the rate of very good partial response or better, minimal residual disease negativity, the complete response rate, and OS, Lonial says. The study also evaluated long-term follow-up outcomes, he explains. The data clearly indicated a sustained PFS benefit with the isatuximab combination vs with carfilzomib and dexamethasone alone, leaving no doubt about the short- and long-term efficacy of the treatment, Lonial emphasizes.

Expecting significant OS differences between the 2 arms of the IKEMA trial in the early relapse setting may not be reasonable given that the average OS for patients with multiple myelomanow exceeds 10 years. Therefore, during the initial 1 to 3 lines of therapy, oncologists should not anticipate substantial OS variations, Lonial explains. Although in IKEMA, the OS trends slightly favored the isatuximab combination, it is reassuring that there was no evidence of an OS decline associated with the investigational regimen, he concludes.