Ontology type: schema:ScholarlyArticle
2019-04
AUTHORSG 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 Karlsson, M Hallek, M Mahler, M Salman, S Sun, C Phelps, S Balasubramanian, A Howes, A Chanan-Khan
ABSTRACTWe 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. More... »
PAGES1-12
http://scigraph.springernature.com/pub.10.1038/s41375-018-0276-9
DOIhttp://dx.doi.org/10.1038/s41375-018-0276-9
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