Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma

G. Fraser, P. Cramer, F. Demirkan, R. Santucci Silva, S. Grosicki, A. Pristupa, A. Janssens, J. Mayer, N. L. Bartlett, M. S. Dilhuydy, H. Pylypenko, J. Loscertales, A. Avigdor, S. Rule, D. Villa, O. Samoilova, P. Panagiotidis, A. Goy, M. A. Pavlovsky, C. KarlssonM. Hallek, M. Mahler, M. Salman, S. Sun, C. Phelps, S. Balasubramanian, A. Howes, A. Chanan-Khan

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Abstract

We report follow-up results from the randomized, placebo-controlled, phase 3 HELIOS trial of ibrutinib+bendamustine and rituximab (BR) for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) without deletion 17p. Overall, 578 patients were randomized 1:1 to either ibrutinib (420 mg daily) or placebo, in combination with 6 cycles of BR, followed by ibrutinib or placebo alone. Median follow-up was 34.8 months (range: 0.1–45.8). Investigator-assessed median progression-free survival (PFS) was not reached for ibrutinib+BR, versus 14.3 months for placebo+BR (hazard ratio [HR] [95% CI], 0.206 [0.159–0.265]; P < 0.0001); 36-month PFS rates were 68.0% versus 13.9%, respectively. The results are consistent with the primary analysis findings (HR = 0.203, as assessed by independent review committee, with 17-month median follow-up). Median overall survival was not reached in either arm; HR (95% CI) for ibrutinib+BR versus placebo: 0.652 (0.454–0.935; P = 0.019). Minimal residual disease (MRD)-negative response rates were 26.3% for ibrutinib+BR and 6.2% for placebo+BR (P < 0.0001). Incidence of treatment-emergent adverse events (including grades 3–4) were generally consistent with the initial HELIOS report. These long-term data support improved survival outcomes and deepening responses with ibrutinib+BR compared with BR in relapsed CLL/SLL.

Original languageEnglish
Pages (from-to)969-980
Number of pages12
JournalLeukemia
Volume33
Issue number4
DOIs
StatePublished - Apr 1 2019

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    Fraser, G., Cramer, P., Demirkan, F., Silva, R. S., Grosicki, S., Pristupa, A., Janssens, A., Mayer, J., Bartlett, N. L., Dilhuydy, M. S., Pylypenko, H., Loscertales, J., Avigdor, A., Rule, S., Villa, D., Samoilova, O., Panagiotidis, P., Goy, A., Pavlovsky, M. A., ... Chanan-Khan, A. (2019). Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. Leukemia, 33(4), 969-980. https://doi.org/10.1038/s41375-018-0276-9