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

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 SunAnne Connor, Kerri Nottage, Natasha Schuier, Sriram Balasubramanian, Angela Howes, Paula Cramer

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalLeukemia and Lymphoma
DOIs
StateAccepted/In press - 2020

Keywords

  • 5-year follow-up
  • HELIOS phase 3 trial
  • Ibrutinib
  • overall survival
  • relapsed chronic lymphocytic leukemia

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.

  • Cite this

    Fraser, G. A. M., Chanan-Khan, A., Demirkan, F., Santucci Silva, R., Grosicki, S., Janssens, A., Mayer, J., Bartlett, N. L., Dilhuydy, M. S., Loscertales, J., Avigdor, A., Rule, S., Samoilova, O., Pavlovsky, M. A., Goy, A., Mato, A., Hallek, M., Salman, M., Tamegnon, M., ... Cramer, P. (Accepted/In press). 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. Leukemia and Lymphoma. https://doi.org/10.1080/10428194.2020.1795159