Universität zu Köln

Sharman, Jeff P., Coutre, Steven E., Furman, Richard R., Cheson, Bruce D., Pagel, John M., Hillmen, Peter, Barrientos, Jacqueline C., Zelenetz, Andrew D., Kipps, Thomas J., Flinn, Ian W., Ghia, Paolo ORCID: 0000-0003-3750-7342, Eradat, Herbert, Ervin, Thomas, Lamanna, Nicole, Coiffier, Bertrand, Pettitt, Andrew R., Ma, Shuo, Tausch, Eugen, Cramer, Paula, Huang, Julie, Mitra, Siddhartha, Hallek, Michael, O'Brien, Susan M. and Stilgenbauer, Stephan (2019). Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia. J. Clin. Oncol., 37 (16). S. 1391 - 1405. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

PURPOSE A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was terminated early because of superior efficacy of the IDELA-plus-rituximab (IDELA/R) arm. Patients in either arm could then enroll in an extension study to receive IDELA monotherapy. Here, we report the long-term efficacy and safety data for IDELA-treated patients across the primary and extension studies. PATIENTS AND METHODS Patients were randomly assigned to receive rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo/R; n = 110). Key end points were progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety. RESULTS The long-term efficacy and safety of treatment with IDELA was assessed in 110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study. The IDELA/R-to-IDELA group had a median PFS of 20.3 months (95% CI, 17.3 to 26.3 months) after a median follow-up time of 18 months (range, 0.3 to 67.6 months). The ORR was 85.5% (94 of 110 patients; n = 1 complete response). The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively. Prolonged exposure to IDELA increased the incidence of all-grade, grade 2, and grade 3 or greater diarrhea (46.4%, 17.3%, and 16.4%, respectively), all-grade and grade 3 or greater colitis (10.9% and 8.2%, respectively) and all-grade and grade 3 or greater pneumonitis (10.0% and 6.4%, respectively) but did not increase the incidence of elevated hepatic aminotransferases. CONCLUSION IDELA improved PFS and OS compared with rituximab alone in patients with relapsed CLL. Long-term IDELA was effective and had an expected safety profile. No new IDELA-related adverse events were identified with longer exposure. (C) 2019 by American Society of Clinical Oncology

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Sharman, Jeff P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Coutre, Steven E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Furman, Richard R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cheson, Bruce D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pagel, John M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hillmen, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Barrientos, Jacqueline C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zelenetz, Andrew D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kipps, Thomas J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Flinn, Ian W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ghia, Paolo UNSPECIFIED orcid.org/0000-0003-3750-7342 UNSPECIFIED Eradat, Herbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Ervin, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Lamanna, Nicole UNSPECIFIED UNSPECIFIED UNSPECIFIED Coiffier, Bertrand UNSPECIFIED UNSPECIFIED UNSPECIFIED Pettitt, Andrew R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ma, Shuo UNSPECIFIED UNSPECIFIED UNSPECIFIED Tausch, Eugen UNSPECIFIED UNSPECIFIED UNSPECIFIED Cramer, Paula UNSPECIFIED UNSPECIFIED UNSPECIFIED Huang, Julie UNSPECIFIED UNSPECIFIED UNSPECIFIED Mitra, Siddhartha UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED O'Brien, Susan M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stilgenbauer, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-146343
DOI:	10.1200/JCO.18.01460
Journal or Publication Title:	J. Clin. Oncol.
Volume:	37
Number:	16
Page Range:	S. 1391 - 1405
Date:	2019
Publisher:	AMER SOC CLINICAL ONCOLOGY
Place of Publication:	ALEXANDRIA
ISSN:	1527-7755
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language COMBINATION; INHIBITOR; CAL-101 Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/14634