Expert perspective on the INSURE study, which pooled data from several trials to observe the real-world effectiveness of IRd in the setting of relapsed/refractory multiple myeloma.
Suzanne Lentzsch, MD, discusses data from the following study:
The INSURE study (INSIGHT MM, UVEA-IXA, REMIX): a pooled analysis of relapsed/refractory multiple myeloma (RRMM) patients (pts) treated with ixazomib-lenalidomide-dexamethasone (IRd) in routine clinical practice. (Leleu X et al. Blood. 2021;138[suppl 1]:2701).
Ixazomib in combination with lenalidomide and dexamethasone has been approved for the treatment of RRMM based on the results of the TOURMALINE-MM1 phase 3 study. However, outcomes in routine clinical practice often differ from data reported in clinical trials for MM therapies, being poorer for real-world versus clinical trial patients.
Several retrospective and prospective observational studies have shown comparable effectiveness of IRd in the second and later lines of therapy (LoTs) in the real-world setting with the efficacy observed in TOURMALINE-MM1, with median progression-free survival (PFS) ranging from 11 months to 43 months. The objective of the current analysis of a large, global dataset pooled from 3 observational studies is to investigate the effectiveness of IRd in the overall RRMM population, by LoT, and in subpopulations of patients defined by frailty status.
In all, 564 adults with RRMM from several clinical trials (INSIGHT, UVEA-IXA, and REMIX) were included in a pooled analysis. Primary outcome measures were time to next therapy and PFS. Secondary outcome measures included duration of therapy, overall survival, overall response rate (ORR), and safety.
Results/Conclusions:
The effectiveness of IRd in routine clinical practice (median PFS, 19.9 months; ORR, 65%) is consistent with the efficacy of IRd observed in the registrational TOURMALINE-MM1 trial (median PFS, 20.6 months; ORR, 78%), with no new safety concerns reported.
A very good partial response was noted among 17% of frail patients vs 42% of nonfrail patients.
The ORR was 70% in the 2nd LoT, 63% in the 3rd LoT, and 53% in the 4th LoT.