MM-253 Efficacy, Safety, and Quality of Life (QoL) in Patients With Newly Diagnosed Multiple Myeloma (NDMM) After In-Class Transition (iCT) From Parenteral Bortezomib-Based Induction Therapy to All-Oral Ixazomib-Lenalidomide-Dexamethasone (IRd): Data From the Phase 4, Community-Based US MM-6 Study (Fully Accrued Cohort)

Sudhir Manda, Habte A. Yimer, Ruemu E. Birhiray, Ralph Boccia, Suman Kambhampati, Joshua Richter, Jack Aiello, Saulius K. Girnius, Dasha Cherepanov, Kim Tran, Presley Whidden, Stephen J. Noga, Robert M. Rifkin

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Abstract

Context: Achieving prolonged therapy with parenteral proteasome inhibitors (PIs) in clinical practice can be challenging. Objective: To increase the duration of PI-based therapy, improve outcomes, and maintain QoL. Design: Prospective study (NCT03173092) evaluating iCT from parenteral bortezomib-based induction to all-oral IRd. IRd was received for up to 39 cycles or until progression/toxicity (Manda CLML 2020). Interim data (N=101) were previously reported (Rifkin ASH 2021). We report results from the fully accrued study cohort (enrollment completed, May 2021; N=141). Setting: US community sites. Patients: Transplant-ineligible/delayed-transplant (≥24 months) NDMM patients with ≥stable disease after 3 cycles of bortezomib-based induction. Main Outcome Measures: Primary endpoint: 2-year progression-free survival (PFS) rate. Other endpoints included: key secondary, overall response rate (ORR; partial response [PR]+very good PR [VPGR]+complete response [CR]) and duration of treatment (DOT); secondary, overall survival (OS), safety, and QoL. Results: At Feb-28-2022, 140 patients (median age, 72.5 years [range, 48–90]; 79% ≥65 years; 42% ≥75 years) had received IRd; 94% had ≥1 comorbidity at IRd initiation. Median follow-up was 20.0 months. 2-year PFS was 69% (95% confidence interval [CI]: 59–77%). ORR was 62% (CR, 8%; VGPR, 24%; PR, 30%) after bortezomib-based induction, increasing to 78% (CR, 33%; VGPR, 27%; PR, 18%) after iCT. At data cut-off, 28 patients (20%) were ongoing on IRd, median DOT with IRd was 10.0 months, and median duration of all PI-based treatment was 12.7 months. 2-year OS was 85% (95% CI: 76–90%). 66% of patients had grade ≥3 treatment-emergent adverse events (TEAEs) (treatment-related, 36%), 44% had serious TEAEs (treatment-related, 14%), and 6 on-study deaths had occurred. Most common TEAEs (any-grade/grade ≥3) were diarrhea (48%/9%), peripheral neuropathies not elsewhere classified (39%/4%), and fatigue (34%/4%). Modification/discontinuation of ixazomib, lenalidomide, or dexamethasone due to TEAEs occurred in 59%/15% of patients. Patient-reported QoL (EORTC QLQ-C30 Global Health Status/QoL score) and treatment satisfaction (TSQM-9 Global Satisfaction, Effectiveness, and Convenience scores) were maintained on IRd. Conclusions: Improved responses and promising PFS and OS were seen following iCT to IRd in these mostly elderly, community-treated patients with NDMM and comorbidities, with no adverse impact on QoL/treatment satisfaction. Safety results were consistent with previous reports.

Original languageEnglish
Pages (from-to)S416-S417
JournalClinical Lymphoma, Myeloma and Leukemia
Volume22
DOIs
StatePublished - Oct 2022

Keywords

  • MM
  • Phase IV
  • in-class transition
  • ixazomib
  • oral therapy
  • proteasome inhibitor
  • routine clinical practice

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