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Summary  Spleen tyrosine kinase (Syk) mediates B‐cell receptor signalling in normal and malignant B cells. Entospletinib is an oral, selective Syk inhibitor. Entospletinib monotherapy was evaluated in a multicentre, phase 2 study of patients with relapsed or refractory indolent non‐Hodgkin lymphoma or mantle cell lymphoma ( MCL ). Subjects received 800 mg entospletinib twice daily. Forty‐one follicular lymphoma ( FL ), 17 lymphoplasmacytoid lymphoma/Waldenström macroglobulinaemia ( LPL / WM ), 17 marginal zone lymphoma ( MZL ) and 39  MCL  patients were evaluated. The primary endpoint was a progression‐free survival ( PFS ) rate (defined as not experiencing progression or death) at 16 weeks for patients with  MCL  and at 24 weeks for patients with  FL ,  LPL / WM  and  MZL . The most common treatment‐emergent adverse events were fatigue, nausea, diarrhoea, vomiting, headache and cough. Common laboratory abnormalities were anaemia, neutropenia and thrombocytopenia; aspartate transaminase, alanine transaminase, total bilirubin and serum creatinine were all increased.  PFS  at 16 weeks in the  MCL  cohort was 63·9% [95% confidence interval ( CI ) 45–77·8%];  PFS  at 24 weeks in the  FL ,  LPL / WM ,  MCL  and  MZL  cohorts was 51·5% (95%  CI  32·8–67·4%), 69·8% (95%  CI  31·8–89·4%), 56·6% (95%  CI  37·5–71·8%) and 46·2% (95%  CI  18·5–70·2%), respectively. Entospletinib had limited single‐agent activity with manageable toxicity in these patient populations.

An open‐label phase 2 trial of entospletinib in indolent non‐Hodgkin lymphoma and mantle cell lymphoma