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- Title
Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in elderly patients with relapsed multiple myeloma: IKEMA subgroup analysis.
- Authors
Facon, Thierry; Moreau, Philippe; Martin, Thomas G.; Spicka, Ivan; Oriol, Albert; Koh, Youngil; Lim, Andrew; Mikala, Gabor; Rosiñol, Laura; Yağci, Münci; Cavo, Michele; Yong, Kwee; Risse, Marie‐Laure; Asset, Gaëlle; Schwab, Sandrine; Martinez, Gracia
- Abstract
In this subgroup analysis of the randomized, Phase 3 IKEMA study (NCT03275285), we evaluated efficacy and safety of the anti‐CD38 monoclonal antibody isatuximab (Isa) in combination with carfilzomib‐dexamethasone (Isa‐Kd) versus Kd in older (≥70 years of age, n = 86) and younger (<70 years, n = 216) patients with relapsed multiple myeloma (MM). Patients received Isa 10 mg/kg intravenously weekly for 4 weeks, then every 2 weeks in the Isa‐Kd arm, and approved schedule of carfilzomib (twice weekly) and dexamethasone in both study arms. Primary endpoint was progression‐free survival (PFS); key secondary efficacy endpoints included rates of overall response (ORR), very good partial response or better (≥VGPR), minimal residual disease negativity (MRD–), and complete response (CR). Addition of Isa to Kd resulted in improved PFS in elderly patients (hazard ratio, 0.36 [95% CI, 0.18–0.75]) consistent with the significant PFS improvement observed in the overall IKEMA population. Treatment with Isa‐Kd improved depth of response versus Kd, with higher rates of ≥VGPR (73.1% vs. 55.9%), MRD– (23.1% vs. 11.8%), and CR (38.5% vs. 23.5%). Although the incidence of grade ≥3 treatment‐emergent adverse events (TEAEs) was higher in Isa‐Kd, the incidence of serious TEAEs was similar between arms. Fewer elderly patients definitively discontinued treatment due to TEAEs in Isa‐Kd than Kd: 11.8% versus 23.5%. In conclusion, Isa‐Kd provides a consistent benefit versus Kd in elderly patients, with a manageable safety profile, and represents a new treatment option for patients with relapsed MM, independent of age.
- Subjects
OLDER patients; MULTIPLE myeloma; SUBGROUP analysis (Experimental design); DEXAMETHASONE; MONOCLONAL antibodies; MONOCLONAL gammopathies
- Publication
Hematological Oncology, 2022, Vol 40, Issue 5, p1020
- ISSN
0278-0232
- Publication type
Article
- DOI
10.1002/hon.3038