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 Conference Paper uri icon

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abstract

  • 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.

authors

  • Fraser, Graeme
  • Chanan-Khan, Asher
  • Demirkan, Fatih
  • Santucci Silva, Rodrigo
  • Grosicki, Sebastian
  • Janssens, Ann
  • Mayer, Jiri
  • Bartlett, Nancy L
  • Dilhuydy, Marie-Sarah
  • Loscertales, Javier
  • Avigdor, Abraham
  • Rule, Simon
  • Samoilova, Olga
  • Pavlovsky, Miguel A
  • Goy, Andre
  • Mato, Anthony
  • Hallek, Michael
  • Salman, Mariya
  • Tamegnon, Monelle
  • Sun, Steven
  • Connor, Anne
  • Nottage, Kerri
  • Schuier, Natasha
  • Balasubramanian, Sriram
  • Howes, Angela
  • Cramer, Paula

publication date

  • November 9, 2020