Jeffery Zonder, MD, Multiple Myeloma Subcommittee Chair, Barbara Ann Karmanos Cancer Institute, Professor of Medicine, Departments of Hematology and Oncology, Wayne State University School of Medicine, discusses the practical use of ixazomib (Ninlaro)-based therapy for patients with relapsed/refractory multiple myeloma as observed in the INSURE study.
In multiple myeloma, data reported in clinical trials of specific therapies can often differ from real-world patient responses, Zonder begins. Many clinical trials exclude patients with common health conditions, and about 72% of patients with relapsed or refractory multiple myeloma don’t meet strict eligibility criteria for randomized clinical trials, Zonder said. Accordingly, these disorders increase frailty, decrease a patient’s ability to respond to or tolerate a particular therapy, and increase difficulty in drug administration, Zonder explains.
“The INSURE study was designed to address this discrepancy and allow for a more comprehensive comparison of survival outcomes with ixazomib, lenalidomide (Revlimid), and dexamethasone (IRd) in the real-world setting versus those seen in clinical trials,” continued Zonder. The study pooled datasets from the observational INSIGHT MM (NCT02761187), Phase 2 UVEA-IXA (NCT03439293) and REMIX (NCT03433001) studies on IRd and compared them to the efficacy of the combination in the Phase 3 TOURMAILINE-MM1 study (NCT01564537).
Results from TOURMALINE-MM1 previously supported FDA approval of IRd for patients with relapsed or refractory multiple myeloma in 2015. In this study, patients receiving IRd achieved an overall response rate (ORR) of 78%. In addition, the median progression-free survival in these patients was 20.6 months.
The analysis showed that the real-world outcomes and toxicities observed with IRd were comparable to those reported in TOURMAILINE-MM1, reports Zonder. In the 564 patients enrolled in INSURE, the mean PFS and ORR were 19.9 months (95% CI: 16.6-23.6) and 65%, respectively. In addition, the mean total time to next treatment (TTNT) for patients in the office was 18.4 months (95% CI: 15.3-20.8). Patients who received IRd in earlier lines had numerically greater TTNT compared to later lines.
The INSURE results confirm the accuracy of the TOURMALINE-MM1 data and support the use of this therapy in clinical practice, Zonder concludes.
