Efficacy and safety of isatuximab monotherapy to treat relapsed or refractory multiple myeloma: a pooled analysis of clinical trials

This pooled analysis of phase 1 and 2 clinical trials evaluated the efficacy and safety of isatuximab as monotherapy in individuals with relapsed or refractory multiple myeloma (RRMM) who had previously received a median of 4.0 lines of therapy; safety data for individuals on isatuximab plus dexamethasone has also been evaluated. The efficacy analysis (n = 167) showed that isatuximab 20 mg/kg monotherapy was effective in the treatment of individuals with RRMM, with an overall response rate (ORR) of 26.3%, a median progression-free survival (PFS) of 5.6 months and a median overall survival (OS) of 20.2 months. Isatuximab demonstrated rapid and sustained efficacy when used as monotherapy, with a median time to response of 1.0 month and a median duration of response of 10.3 months. The safety analysis, which included 477 participants from four clinical trials, showed that isatuximab had an acceptable safety profile that was consistent across all the dose groups examined. The most common treatment-emergent adverse events were infusion reactions (in 45.7% of participants), most of which were of grade 1 or 2 severity and occurred during the first infusion. Overall, no safety concerns were identified. In addition, participants aged ≥ 75 years had higher ORR and longer PFS and OS than those aged < 65 years, and since the proportions of patients with an Eastern Cooperative Oncology Group performance status of 2 did not vary significantly by age group, it appears that age does not affect the efficacy and safety of isatuximab treatment in RRMM. Further research is warranted to elaborate upon these findings.