TY - JOUR
T1 - Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
AU - Fraser, Graeme A.M.
AU - Chanan-Khan, Asher
AU - Demirkan, Fatih
AU - Santucci Silva, Rodrigo
AU - Grosicki, Sebastian
AU - Janssens, Ann
AU - Mayer, Jiri
AU - Bartlett, Nancy L.
AU - Dilhuydy, Marie Sarah
AU - Loscertales, Javier
AU - Avigdor, Abraham
AU - Rule, Simon
AU - Samoilova, Olga
AU - Pavlovsky, Miguel A.
AU - Goy, Andre
AU - Mato, Anthony
AU - Hallek, Michael
AU - Salman, Mariya
AU - Tamegnon, Monelle
AU - Sun, Steven
AU - Connor, Anne
AU - Nottage, Kerri
AU - Schuier, Natasha
AU - Balasubramanian, Sriram
AU - Howes, Angela
AU - Cramer, Paula
N1 - Publisher Copyright:
© 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2020
Y1 - 2020
N2 - We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p (n = 578) were randomized 1:1 to 420 mg daily ibrutinib or placebo plus ≤6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone. Median follow-up was 63.7 months. Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229 [95% confidence interval (CI) 0.183–0.286]; p <.0001). Despite crossover of 63.3% of patients from the placebo plus BR arm to ibrutinib treatment upon disease progression, ibrutinib plus BR versus placebo plus BR demonstrated an overall survival benefit (HR 0.611 [95% CI 0.455–0.822]; p =.0010; median not reached in either arm). Long-term follow-up data confirm the survival benefit of ibrutinib plus BR over BR alone. Safety profiles were consistent with those known for ibrutinib and BR.
AB - We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p (n = 578) were randomized 1:1 to 420 mg daily ibrutinib or placebo plus ≤6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone. Median follow-up was 63.7 months. Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229 [95% confidence interval (CI) 0.183–0.286]; p <.0001). Despite crossover of 63.3% of patients from the placebo plus BR arm to ibrutinib treatment upon disease progression, ibrutinib plus BR versus placebo plus BR demonstrated an overall survival benefit (HR 0.611 [95% CI 0.455–0.822]; p =.0010; median not reached in either arm). Long-term follow-up data confirm the survival benefit of ibrutinib plus BR over BR alone. Safety profiles were consistent with those known for ibrutinib and BR.
KW - 5-year follow-up
KW - HELIOS phase 3 trial
KW - Ibrutinib
KW - overall survival
KW - relapsed chronic lymphocytic leukemia
UR - http://www.scopus.com/inward/record.url?scp=85089198842&partnerID=8YFLogxK
U2 - 10.1080/10428194.2020.1795159
DO - 10.1080/10428194.2020.1795159
M3 - Article
C2 - 32762271
AN - SCOPUS:85089198842
SN - 1042-8194
VL - 61
SP - 3188
EP - 3197
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 13
ER -