KEY TAKEAWAYS
- The phase IV trial aimed to evaluate the efficacy and safety of switching from injectable bortezomib to oral ixazomib in newly diagnosed MM patients.
- The primary endpoint was PFS. Secondary endpoints were ORR, OS, and safety.
- The study found that in-class transition to ixazomib-based therapy offered an effective alternative to induction/maintenance therapy for newly diagnosed MM, particularly in elderly and frail patients.
Long-term proteasome inhibitor (PI) therapy is effective for multiple myeloma (MM), but practical challenges arise due to PI-related toxicity and administration burden, especially in elderly or frail patients. Researchers aimed to evaluate the efficacy and safety of switching from injectable bortezomib to oral ixazomib in newly diagnosed MM patients.
After undergoing three cycles of V-based induction, eligible patients with newly diagnosed multiple myeloma (NDMM) were enrolled to receive up to 39 cycles of IRd. The primary endpoint was the 2-year progression-free survival (PFS), with secondary endpoints including treatment duration, overall response rate (ORR), overall survival (OS), and safety. These endpoints were evaluated based on age (<75 vs ≥75 years) and frailty status (non-frail vs frail).
About 140 patients who received IRd, 42% were aged ≥75 years (median age: 73 years), with 61% classified as frail. The median follow-up was 27 months. Ongoing IRd treatment was reported in 12% (aged <75) vs 7% (aged ≥75) and 13% (non-frail) vs 8% (frail). The median IRd duration was 11 months overall, varying between 14 vs 9 months (aged <75 vs ≥75) and 12 vs 10 months (non-frail vs frail). The overall median duration of all PI-based therapies was 14 months, differing by age (18 vs 12 months) and frailty status (15 vs 13 months).ORR rose 62% at the induction end (including CR: 8%) to 80% post-iCT to IRd (including CR: 37%).
Stratified by age, ORR increased from 60% to 80% (aged <75) and 64% to 80% (aged ≥75), while in non-frail vs frail subgroups, ORR increased from 70% to 81% and 57% to 79%, respectively. The overall 2-year PFS rate was 71% (95% CI: 61–78), showing comparable figures in age 72%(95% CI: 60─81 vs 67%(95% CI: 50─80)) and frailty status (74% vs 68%). Median PFS and OS were not reached overall or in any subgroup.
The study found that in-class transition to ixazomib-based therapy offers a safe and effective alternative to induction/maintenance therapy for newly diagnosed MM, particularly in elderly and frail patients.
Clinical Trial: https://clinicaltrials.gov/study/NCT03173092
Ferreira I. In-class transition (iCT) from parenteral bortezomib (V) to oral ixazomib in multiple myeloma (MM) by age and frailty status: Updated subgroup analysis from the fully accrued US MM-6 study.
