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

J 2019

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

FRASER, G., P. CRAMER, F. DEMIRKAN, R.S. SILVA, S. GROSICKI et. al.

Basic information

Original name

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

Authors

FRASER, G. (124 Canada), P. CRAMER (276 Germany), F. DEMIRKAN (792 Turkey), R.S. SILVA (76 Brazil), S. GROSICKI (616 Poland), A. PRISTUPA (643 Russian Federation), A. JANSSENS (56 Belgium), Jiří MAYER (203 Czech Republic, belonging to the institution), N.L. BARTLETT (840 United States of America), M.S. DILHUYDY (250 France), H. PYLYPENKO (804 Ukraine), J. LOSCERTALES (724 Spain), A. AVIGDOR (376 Israel), S. RULE (826 United Kingdom of Great Britain and Northern Ireland), D. VILLA (124 Canada), O. SAMOILOVA (643 Russian Federation), P. PANAGIOTIDIS (300 Greece), A. GOY (840 United States of America), M.A. PAVLOVSKY (32 Argentina), C. KARLSSON (752 Sweden), M. HALLEK (276 Germany), M. MAHLER (840 United States of America), M. SALMAN (840 United States of America), S. SUN (840 United States of America), C. PHELPS (840 United States of America), S. BALASUBRAMANIAN (840 United States of America), A. HOWES (826 United Kingdom of Great Britain and Northern Ireland) and A. CHANAN-KHAN (826 United Kingdom of Great Britain and Northern Ireland)

Edition

Leukemia, London, Nature Publishing Group, 2019, 0887-6924

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 8.665

RIV identification code

RIV/00216224:14110/19:00109488

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1038/s41375-018-0276-9

UT WoS

000463162400012

Keywords in English

ibrutinib; bendamustine; rituximab

Abstract

V originále

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.

Citovat

FRASER, G., P. CRAMER, F. DEMIRKAN, R.S. SILVA, S. GROSICKI, A. PRISTUPA, A. JANSSENS, Jiří 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 and A. CHANAN-KHAN. Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. Leukemia. London: Nature Publishing Group, 2019, vol. 33, No 4, p. 969-980. ISSN 0887-6924. Available from: https://dx.doi.org/10.1038/s41375-018-0276-9.

@article{1522776,
   author = {Fraser, G. and Cramer, P. and Demirkan, F. and Silva, R.S. and Grosicki, S. and Pristupa, A. and Janssens, A. and Mayer, Jiří and Bartlett, N.L. and Dilhuydy, M.S. and Pylypenko, H. and Loscertales, J. and Avigdor, A. and Rule, S. and Villa, D. and Samoilova, O. and Panagiotidis, P. and Goy, A. and Pavlovsky, M.A. and Karlsson, C. and Hallek, M. and Mahler, M. and Salman, M. and Sun, S. and Phelps, C. and Balasubramanian, S. and Howes, A. and ChananandKhan, A.},
   article_location = {London},
   article_number = {4},
   doi = {http://dx.doi.org/10.1038/s41375-018-0276-9},
   keywords = {ibrutinib; bendamustine; rituximab},
   language = {eng},
   issn = {0887-6924},
   journal = {Leukemia},
   title = {Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma},
   url = {http://dx.doi.org/10.1038/s41375-018-0276-9},
   volume = {33},
   year = {2019}
}

TY  - JOUR
ID  - 1522776
AU  - Fraser, G. - Cramer, P. - Demirkan, F. - Silva, R.S. - Grosicki, S. - Pristupa, A. - Janssens, A. - Mayer, Jiří - 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. - Chanan-Khan, A.
PY  - 2019
TI  - Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma
JF  - Leukemia
VL  - 33
IS  - 4
SP  - 969-980
EP  - 969-980
PB  - Nature Publishing Group
SN  - 08876924
KW  - ibrutinib
KW  - bendamustine
KW  - rituximab
UR  - http://dx.doi.org/10.1038/s41375-018-0276-9
L2  - http://dx.doi.org/10.1038/s41375-018-0276-9
N2  - 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.
ER  -

FRASER, G., P. CRAMER, F. DEMIRKAN, R.S. SILVA, S. GROSICKI, A. PRISTUPA, A. JANSSENS, Jiří 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 and A. CHANAN-KHAN. Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. \textit{Leukemia}. London: Nature Publishing Group, 2019, vol.~33, No~4, p.~969-980. ISSN~0887-6924. Available from: https://dx.doi.org/10.1038/s41375-018-0276-9.

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