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

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Bibtex

@article{5d8bf9fc671d4250a55009d655f2be1d,
title = "Impact of prior therapy on the efficacy and safety of oral ixazomib-lenalidomide-dexamethasone vs. placebo-lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma in TOURMALINE-MM1",
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-dexamethasone (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 (proteasome 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 -na{\"i}ve patients, HR 0.744 and 0.700 in immunomodulatory-drug-exposed and -na{\"i}ve 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. TOURMALINE-MM1 registered at clinicaltrials.gov identifier: 01564537.",
keywords = "Journal Article",
author = "Mar{\'i}a-Victoria Mateos and Tamas Masszi and Norbert Grzasko and Markus Hansson and Irwindeep Sandhu and Ludek Pour and Lu{\'i}sa Viterbo and Jackson, {Sharon R} and Anne-Marie Stoppa and Peter Gimsing and Mehdi Hamadani and Gabriela Borsaru and Deborah Berg and Jianchang Lin and {Di Bacco}, Alessandra and {van de Velde}, Helgi and Richardson, {Paul G} and Philippe Moreau",
note = "Copyright{\circledC} 2017 Ferrata Storti Foundation.",
year = "2017",
month = "10",
doi = "10.3324/haematol.2017.170118",
language = "English",
volume = "102",
pages = "1767--1775",
journal = "Haematologica-The Hematology Journal",
issn = "1592-8721",
publisher = "Ferrata Storti Foundation",
number = "10",

}