Two-year outcomes of tirabrutinib monotherapy in Waldenstrom's macroglobulinemia.

ABSTRACT: The phase II study of tirabrutinib monotherapy at a daily dose of 480 mg under fasting conditions for treatment-naïve and relapsed/refractory Waldenström's macroglobulinemia (ONO-4059-05 study) demonstrated a promising efficacy and tolerable safety profile. We conducted an unplanned analysis with a median follow-up of 24.8 months to update the efficacy and safety results and to report patient-reported quality of life. Of 27 enrolled patients, 22 patients continued receiving the study drug. The major response assessed by an independent review committee was observed in 25 patients (93%), including one and five patients who newly achieved complete response and very good partial response, respectively, after the primary analysis. The progression-free and overall survival rates at 24 months wer

SUBMITTER: Sekiguchi N 

PROVIDER: S-EPMC9207369 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature