TY - JOUR
T1 - Deepening responses associated with improved progression-free survival with ixazomib versus placebo as posttransplant maintenance in multiple myeloma
AU - Goldschmidt, Hartmut
AU - Dimopoulos, Meletios A.
AU - Rajkumar, S. Vincent
AU - Weisel, Katja C.
AU - Moreau, Philippe
AU - Chng, Wee Joo
AU - Mikala, Gábor
AU - Cavo, Michele
AU - Ramasamy, Karthik
AU - Suryanarayan, Kaveri
AU - Teng, Zhaoyang
AU - Labotka, Richard
AU - Mateos, Maria Victoria
N1 - Funding Information:
Acknowledgements The authors acknowledge Steve Hill PhD of FireKite, an Ashfield company, part of UDG Healthcare plc, for professional medical writing support, which was funded by Millennium Pharmaceuticals Inc, Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, and complied with Good Publication Practice-3 (GPP3) guidelines (Battisti WP et al. Ann Intern Med. 2015;163:461–4), and Renda Ferrari, PhD (Millennium Pharmaceuticals, Inc), for contributing to the editorial and scientific content of the manuscript. The TOURMALINE-MM3 study was funded by Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. Open access funding provided by Projekt DEAL.
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/11/1
Y1 - 2020/11/1
N2 - In the TOURMALINE-MM3 study, post-autologous stem cell transplantation maintenance therapy with the oral proteasome inhibitor ixazomib versus placebo significantly improved progression-free survival (PFS), with a favorable safety profile. With ixazomib versus placebo maintenance, deepening responses occurred in 139/302 (46%) versus 60/187 (32%) patients with very good partial response or partial response (VGPR/PR) at study entry (relative risk 1.41, P = 0.004), and median time to best confirmed deepened response was 19.9 versus 30.8 months (24-month rate: 54.2 versus 41.4%; hazard ratio (HR): 1.384; P = 0.0342). Median PFS in patients with VGPR/PR at study entry was 26.2 versus 18.5 months (HR: 0.636, P < 0.001) with ixazomib versus placebo; in a pooled analysis across arms, in patients with versus without deepening responses, the median PFS was not reached versus 15.9 months (HR: 0.245, P < 0.001). In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028). These analyses demonstrate the significantly higher rate of deepening responses with ixazomib versus placebo maintenance and the association between deepening response and prolonged PFS.
AB - In the TOURMALINE-MM3 study, post-autologous stem cell transplantation maintenance therapy with the oral proteasome inhibitor ixazomib versus placebo significantly improved progression-free survival (PFS), with a favorable safety profile. With ixazomib versus placebo maintenance, deepening responses occurred in 139/302 (46%) versus 60/187 (32%) patients with very good partial response or partial response (VGPR/PR) at study entry (relative risk 1.41, P = 0.004), and median time to best confirmed deepened response was 19.9 versus 30.8 months (24-month rate: 54.2 versus 41.4%; hazard ratio (HR): 1.384; P = 0.0342). Median PFS in patients with VGPR/PR at study entry was 26.2 versus 18.5 months (HR: 0.636, P < 0.001) with ixazomib versus placebo; in a pooled analysis across arms, in patients with versus without deepening responses, the median PFS was not reached versus 15.9 months (HR: 0.245, P < 0.001). In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028). These analyses demonstrate the significantly higher rate of deepening responses with ixazomib versus placebo maintenance and the association between deepening response and prolonged PFS.
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U2 - 10.1038/s41375-020-0819-8
DO - 10.1038/s41375-020-0819-8
M3 - Article
C2 - 32327729
AN - SCOPUS:85083776145
VL - 34
SP - 3019
EP - 3027
JO - Leukemia
JF - Leukemia
SN - 0887-6924
IS - 11
ER -