TY - JOUR
T1 - Entospletinib monotherapy in patients with relapsed or refractory chronic lymphocytic leukemia previously treated with B-cell receptor inhibitors
T2 - results of a phase 2 study
AU - Awan, Farrukh T.
AU - Thirman, Michael J.
AU - Patel-Donnelly, Dipti
AU - Assouline, Sarit
AU - Rao, Arati V.
AU - Ye, Wei
AU - Hill, Brian
AU - Sharman, Jeff P.
N1 - Funding Information:
Financial support for this study was provided by Gilead Sciences, Inc.
Publisher Copyright:
© 2019, © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2019/7/3
Y1 - 2019/7/3
N2 - Entospletinib (GS-9973), an oral, selective inhibitor of spleen tyrosine kinase (SYK), was evaluated as monotherapy in this multicenter, phase 2 study (NCT01799889) of 49 patients with relapsed or refractory chronic lymphocytic leukemia (CLL), including those with Richter’s transformation (RT), who had received prior therapy with a B-cell receptor (BCR) inhibitor. Patients were treated with entospletinib 400 mg BID as the starting dose. Sixteen patients achieved partial response and 21 had stable disease. The overall response rate was 32.7% (95% confidence interval [CI]: 21.7–45.3%). The median progression-free survival (PFS) was 5.6 (95% CI: 3.7–8.3) months. Twenty-one (of 43) patients (48.8%) experienced nodal response. Adverse events (AEs) occurred in all patients; most commonly fatigue, diarrhea, and anemia. Entospletinib monotherapy has clinical activity for patients with CLL and RT who have relapsed following therapy with BCR inhibitors.
AB - Entospletinib (GS-9973), an oral, selective inhibitor of spleen tyrosine kinase (SYK), was evaluated as monotherapy in this multicenter, phase 2 study (NCT01799889) of 49 patients with relapsed or refractory chronic lymphocytic leukemia (CLL), including those with Richter’s transformation (RT), who had received prior therapy with a B-cell receptor (BCR) inhibitor. Patients were treated with entospletinib 400 mg BID as the starting dose. Sixteen patients achieved partial response and 21 had stable disease. The overall response rate was 32.7% (95% confidence interval [CI]: 21.7–45.3%). The median progression-free survival (PFS) was 5.6 (95% CI: 3.7–8.3) months. Twenty-one (of 43) patients (48.8%) experienced nodal response. Adverse events (AEs) occurred in all patients; most commonly fatigue, diarrhea, and anemia. Entospletinib monotherapy has clinical activity for patients with CLL and RT who have relapsed following therapy with BCR inhibitors.
KW - B-cell receptor inhibitors
KW - Richter’s transformation
KW - SYK
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U2 - 10.1080/10428194.2018.1562180
DO - 10.1080/10428194.2018.1562180
M3 - Article
C2 - 30633573
AN - SCOPUS:85060025577
SN - 1042-8194
VL - 60
SP - 1972
EP - 1977
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 8
ER -