Fraser, G., Cramer, P., Demirkan, F., Silva, R. Santucci, 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., Karlsson, C., Hallek, M., Mahler, M., Salman, M., Sun, S., Phelps, C., Balasubramanian, S., Howes, A. and 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). S. 969 - 981. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

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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 34) 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fraser, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Demirkan, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Silva, R. SantucciUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grosicki, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pristupa, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Janssens, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mayer, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bartlett, N. L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dilhuydy, M-SUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pylypenko, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loscertales, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Avigdor, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rule, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Villa, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Samoilova, O.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Panagiotidis, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goy, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pavlovsky, M. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Karlsson, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mahler, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salman, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sun, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Phelps, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Balasubramanian, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Howes, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chanan-Khan, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-152378
DOI: 10.1038/s41375-018-0276-9
Journal or Publication Title: Leukemia
Volume: 33
Number: 4
Page Range: S. 969 - 981
Date: 2019
Publisher: NATURE PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 1476-5551
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
KINASE INHIBITOR IBRUTINIB; ATRIAL-FIBRILLATION; RESIDUAL DISEASE; CHEMOIMMUNOTHERAPY; WORKING; CLLMultiple languages
Oncology; HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/15237

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