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  • Richardson, Paul G. (author)

Final Overall Survival Analysis of the TOURMALINE-MM1 Phase III Trial of Ixazomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • 2021

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  • LIBRIS-ID:oai:gup.ub.gu.se/310977
  • https://gup.ub.gu.se/publication/310977URI
  • https://doi.org/10.1200/JCO.21.00972DOI

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  • Language:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

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  • PURPOSE: The double-blind, placebo-controlled, phase III TOURMALINE-MM1 study demonstrated a statistically significant improvement in progression-free survival with ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) versus placebo-Rd in patients with relapsed or refractory multiple myeloma. We report the final analyses for overall survival (OS). PATIENTS AND METHODS: Patients were randomly assigned to ixazomib-Rd (n = 360) or placebo-Rd (n = 362), stratified by number of prior therapies (1 v 2 or 3), previous proteasome inhibitor (PI) exposure (yes v no), and International Staging System disease stage (I or II v III). OS (intent-to-treat population) was a key secondary end point. RESULTS: With a median follow-up of 85 months, median OS with ixazomib-Rd versus placebo-Rd was 53.6 versus 51.6 months (hazard ratio, 0.939; P = .495). Lower hazard ratios, indicating larger magnitude of OS benefit with ixazomib-Rd versus placebo-Rd, were seen in predefined subgroups: refractory to any (0.794) or last (0.742) treatment line; age > 65-75 years (0.757); International Staging System stage III (0.779); 2/3 prior therapies (0.845); high-risk cytogenetics (0.870); and high-risk cytogenetics and/or 1q21 amplification (0.862). Following ixazomib-Rd versus placebo-Rd, 71.7% versus 69.9% of patients received ≥ 1 anticancer therapy, of whom 24.7% versus 33.9% received daratumumab and 71.8% versus 76.9% received PIs (next-line therapy: 47.5% v 55.8%). Rates of new primary malignancies were similar with ixazomib-Rd (10.3%) and placebo-Rd (11.9%). There were no new or additional safety concerns. CONCLUSION: Median OS values in both arms were the longest reported in phase III studies of Rd-based triplets in relapsed or refractory multiple myeloma at the time of this analysis; progression-free survival benefit with ixazomib-Rd versus placebo-Rd did not translate into a statistically significant OS benefit on intent-to-treat analysis. OS benefit was greater in subgroups with adverse prognostic factors. OS interpretation was confounded by imbalances in subsequent therapies received, especially PIs and daratumumab.

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  • Kumar, Shaji K. (author)
  • Masszi, Tamás (author)
  • Grzasko, Norbert (author)
  • Bahlis, Nizar J. (author)
  • Hansson, MarkusGothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition(Swepub:gu)xhmarn (author)
  • Pour, Luděk (author)
  • Sandhu, Irwindeep (author)
  • Ganly, Peter (author)
  • Baker, Bartrum W. (author)
  • Jackson, Sharon R. (author)
  • Stoppa, Anne Marie (author)
  • Gimsing, Peter (author)
  • Garderet, Laurent (author)
  • Touzeau, Cyrille (author)
  • Buadi, Francis K. (author)
  • Laubach, Jacob P. (author)
  • Cavo, Michele (author)
  • Darif, Mohamed (author)
  • Labotka, Richard (author)
  • Berg, Deborah (author)
  • Moreau, Philippe (author)
  • Göteborgs universitetInstitutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition (creator_code:org_t)

Related titles

  • In:Journal of clinical oncology : official journal of the American Society of Clinical Oncology39:22, s. 2430-24421527-7755

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