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.

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: Graeme A M Fraser, Asher Chanan-Khan, Fatih Demirkan, Rodrigo Santucci Silva, Sebastian Grosicki, Ann Janssens, Jiri Mayer, Nancy L Bartlett, Marie-Sarah Dilhuydy, Javier Loscertales, Abraham Avigdor, Simon Rule, Olga Samoilova, Miguel A Pavlovsky, Andre Goy, Anthony Mato, Michael Hallek, Mariya Salman, Monelle Tamegnon, Steven Sun, Anne Connor, Kerri Nottage, Natasha Schuier, Sriram Balasubramanian, Angela Howes, Paula Cramer
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 61 Issue 13 Pg. 3188-3197 (12 2020) ISSN: 1029-2403 [Electronic] United States
• PMID: 32762271 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Piperidines
• ibrutinib
• Rituximab
• Bendamustine Hydrochloride
• Adenine

Topics

• Adenine (analogs & derivatives)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Bendamustine Hydrochloride (therapeutic use)
• Humans
• Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy)
• Piperidines
• Rituximab (therapeutic use)