Clini Cancer Research: New BTK inhibitor Zanubrutinib treatment recurrent/refractive MCL

Objective: Set celllymphoma(MCL) is an incurable mature B-cell tumor with a high initial remission rate, but most cases tend to recurThe prognosis of patients with recurrence is poor and treatment options are limitedThe purpose of this study was to evaluate the efficacy and safety of a new selective Bruton tyrosine kinase (BTK) inhibitor, zanubrutinib, for MCLMethod: This study is an open Phase II trial of one arm, recruiting recurrent/refractive MCL, treating zanubrutinib, 160mg oral 2/dayThe primary endpoints are the Overall Mitigation Rate (ORR); secondary endpoints include mitigation duration (DOR), how long to achieve mitigation, progression-free survival (PFS), and securityresults: a total of 86 patients (median 60.5 years old) were recruited, with the median treatment being 2-wire treatment, and the patients were given at least one dose of the research drugAfter 18.4 months of median follow-up, 72 (84%) patients received objective remission, of which 59 (68.8%) received full remission (CR)The median DOR and PFS were 19.5 months and 22.1 months, respectively, while the 12-month incident-free events were estimated at 78% and 76% respectivelyThe most common adverse events (AE) of level 3 and above had neutrophil decline (19.8%) and lunginfection/pneumonia (9.3%)Three patients had a large haemorrhage and no atrial fibrillationEight (9.3%) patients were treated with a discontinued zanubrutinib due to AEConclusion: This study shows that patients with recurrent/refractive MCL can obtain high ERR and CR rates with zanubrutinib treatment, and have good tolerance