Impact of prior therapy on the efficacy and safety of oral ixazomiblenalidomide-dexamethasone vs. Placebo-lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in TOURMALINE-MM1

María Victoria Mateos, Tamas Masszi, Norbert Grzasko, Markus Hansson, Irwindeep Sandhu, Ludek Pour, Luísa Viterbo, Sharon R. Jackson, Anne Marie Stoppa, Peter Gimsing, Mehdi Hamadani, Gabriela Borsaru, Deborah Berg, Jianchang Lin, Alessandra Di Bacco, Helgi Van De Velde, Paul G. Richardson, Philippe Moreau

Research output: Article

24 Citations (Scopus)

Abstract

Prior treatment exposure in patients with relapsed/refractory multiple myeloma may affect outcomes with subsequent therapies. We analyzed efficacy and safety according to prior treatment in the phase 3 TOURMALINE-MM1 study of ixazomib-lenalidomide-dexam-ethasone (ixazomib-Rd) versus placebo-Rd. Patients with relapsed/refractory multiple myeloma received ixazomib-Rd or placebo-Rd. Efficacy and safety were evaluated in subgroups defined according to type (pro-teasome inhibitor [PI] and immunomodulatory drug) and number (1 vs. 2 or 3) of prior therapies received. Of 722 patients, 503 (70%) had received a prior PI, and 397 (55%) prior lenalidomide/thalidomide; 425 patients had received 1 prior therapy, and 297 received 2 or 3 prior therapies. At a median follow up of ~15 months, PFS was prolonged with ixazomib-Rd vs. placebo-Rd regardless of type of prior therapy received; HR 0.739 and 0.749 in PI-exposed and –naïve patients, HR 0.744 and 0.700 in immunomodulatory-drug-exposed and -naïve patients, respectively. PFS benefit with ixazomib-Rd vs. placebo-Rd appeared greater in patients with 2 or 3 prior therapies (HR 0.58) and in those with 1 prior therapy without prior transplant (HR 0.60) versus those with 1 prior therapy and transplant (HR 1.23). Across all subgroups, toxicity was consistent with that seen in the intent-to-treat population. In patients with relapsed/refractory multiple myeloma, ixazomib-Rd was associated with a consistent clinical benefit vs. placebo-Rd regardless of prior treatment with bortezomib or immunomodulatory drugs. Patients with 2 or 3 prior therapies, or 1 prior therapy without transplant seemed to have greater benefit than patients with 1 prior therapy and transplant.

Original languageEnglish
Pages (from-to)1767-1775
Number of pages9
JournalHaematologica
Volume102
Issue number10
DOIs
Publication statusPublished - szept. 30 2017

ASJC Scopus subject areas

  • Hematology

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    Mateos, M. V., Masszi, T., Grzasko, N., Hansson, M., Sandhu, I., Pour, L., Viterbo, L., Jackson, S. R., Stoppa, A. M., Gimsing, P., Hamadani, M., Borsaru, G., Berg, D., Lin, J., Di Bacco, A., Van De Velde, H., Richardson, P. G., & Moreau, P. (2017). Impact of prior therapy on the efficacy and safety of oral ixazomiblenalidomide-dexamethasone vs. Placebo-lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in TOURMALINE-MM1. Haematologica, 102(10), 1767-1775. https://doi.org/10.3324/haematol.2017.170118