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Panobinostat plus bortezomib and dexamethasone in previously treated multiple myeloma: outcomes by prior treatment.

Authors :
Richardson, Paul G.
Hungria, Vânia T. M.
Sung-Soo Yoon
Beksac, Meral
Dimopoulos, Meletios Athanasios
Elghandour, Ashraf
Jedrzejczak, Wieslaw W.
Guenther, Andreas
Thanyaphong Na Nakorn
Siritanaratkul, Noppadol
Schlossman, Robert L.
Jian Hou
Moreau, Philippe
Lonial, Sagar
Jae Hoon Lee
Einsele, Hermann
Sopala, Monika
Bengoudifa, Bourras-Rezki
Corrado, Claudia
Binlich, Florence
Source :
Blood. 2/11/2016, Vol. 127 Issue 6, p713-721. 9p.
Publication Year :
2016

Abstract

Panobinostat is a potent pan-deacetylase inhibitor that affects the growth and survival of multiple myeloma (MM) cells through alteration of epigenetic mechanisms and protein metabolism. Panobinostat plus bortezomib and dexamethasone (PAN-BTZ-Dex) led to a significant increase in progression-free survival (PFS) vs placebo plus bortezomib and dexamethasone (Pbo-BTZ-Dex) in patients with relapsed or relapsed and refractory MM in the phase 3 PANORAMA 1 trial. This subgroup analysis evaluated outcomes in patients in the PANORAMA 1 trial based on prior treatment: a prior immunomodulatory drug (IMiD; n = 485), prior bortezomib plus an IMiD (n = 193), and ≥2 prior regimens including bortezomib and an IMiD (n = 147). Median PFS with PAN-BTZ-Dex vs Pbo-BTZ-Dex across subgroups was as follows: prior IMiD (12.3 vs 7.4 months; hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.43-0.68), prior bortezomib plus IMiD (10.6 vs 5.8 months; HR, 0.52; 95% CI, 0.36-0.76), and ≥2 prior regimens including bortezomib and an IMiD (12.5 vs 4.7 months; HR, 0.47; 95% CI, 0.31-0.72). Common grade 3/4 adverse events and laboratory abnormalities in patients who received PAN-BTZ-Dex across the prior treatment groups included thrombocytopenia, lymphopenia, neutropenia, diarrhea, and asthenia/fatigue. Incidence of on-treatment deaths among patients who received prior bortezomib and an IMiD (regardless of number of prior regimens) was similar between treatment arms. This analysis demonstrated a clear PFS benefit of 7.8 months with PAN-BTZ-Dex among patients who received ≥2 prior regimens including bortezomib and an IMiD, a population with limited treatment options and poorer prognosis. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
00064971
Volume :
127
Issue :
6
Database :
Academic Search Index
Journal :
Blood
Publication Type :
Academic Journal
Accession number :
113169611
Full Text :
https://doi.org/10.1182/blood-2015-09-665018