Dr Maximilian Merz speaks to ecancer about the phase 3 ICARIA-MM data in difficult-to-treat patients with RRMM, including the elderly and renally impaired.

Dr Merz reviews the ICARIA-MM trial, which evaluated isatuximab + Pd vs Pd alone in patients with RRMM, noting that the primary endpoint was met and showed a significant improvement in mPFS in the isatuximab arm (11.53 months vs 6.47 months with Pd alone [95% CI: 0.44, 0.81; P=0.001]).

He then discusses some of the challenges faced in the treatment of RRMM, including a variety of disease-related factors as well as patient-related factors like older age, comorbidities, and renal impairment.

Dr Merz notes that about 20% of patients in the ICARIA-MM trial were ≥75 years of age, which he points out reflects a real-world treatment setting given multiple myeloma primarily affects older patients. Addressing renal impairment as a treatment challenge commonly seen in clinical practice, Dr Merz notes that 39% of patients in the ICARIA-MM trial were renally impaired.

Dr Merz comments that the mPFS was significantly improved in the elderly population by the isatuximab + Pd combination, with 11.4 months vs 4.5 months with Pd alone, and a low hazard ratio of 0.48 (95% CI: 0.242, 0.946). This shows that the addition of isatuximab was beneficial in this difficult-to-treat population.

He points out that with a hazard ratio of 0.50, mPFS was also significantly improved in the renal impairment population by isatuximab + Pd (95% CI: 0.30, 0.85).

Dr Merz then comments on the safety profile of isatuximab + Pd in both the elderly and renally impaired subgroups.

Among patients with renal impairment at baseline, the incidence of grade ≥3 and serious TEAEs was greater in the isatuximab + Pd arm vs the Pd arm (91% and 78% vs 79% and 60%, respectively).

Among elderly patients at baseline, the incidence of grade ≥3 and serious TEAEs was greater in the isatuximab + Pd arm vs the Pd arm (94% and 75% vs 69% and 57%, respectively).

Dr Merz concludes by noting the clinical significance of renal impairment in multiple myeloma, where the incidence is as high as 50% and the likelihood of experiencing renal impairment increases with every relapse. He also notes that it is a high-risk factor associated with shorter PFS and OS. For these reasons, he comments that the PFS benefit seen with isatuximab + Pd is clinically meaningful for elderly and renally impaired patients with RRMM.

CrR=complete renal response; mPFS=median progression-free survival; OS=overall survival; Pd=pomalidomide and dexamethasone; PFS=progression-free survival; RRMM=relapsed and refractory multiple myeloma.

ecancer's filming has been kindly supported by Sanofi through the ecancer Global Foundation.

The content of this video is based on the SARCLISA^® EU Summary of Product Characteristics which can be accessed by clicking the link below:

https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf

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MAT-GLB-2200360(1.0) 04/22