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:
Sanofi does not recommend the use of its products in any manner inconsistent with that described in the label available in your country. Please refer to your local product labelling information before prescribing; view your country-specific product labelling information here. If this link does not directly go to your country-specific product labelling information, it can be accessed from the bottom of the screen here.
MAT-GLB-2200360 (1.0) 05/22