Astellas Pharma's XOSPATA meets primary overall survival endpoint in phase three confirmatory trial
30 March 2021 -

Japan-based Astellas Pharma Inc (TSE: 4503) has announced that it has met its primary endpoint of overall survival in a phase three confirmatory trial of XOSPATA (gilteritinib) in patients with relapsed (disease that has returned) or refractory (resistant to treatment) FLT3 mutation-positive (FLT3mut+) acute myeloid leukaemia (AML) compared to chemotherapy at a planned interim analysis, it was reported on 29 March 2021.

The study, named COMMODORE was an open-label, randomised study of gilteritinib compared to salvage chemotherapy in adult patients who have relapsed or refractory AML in China and other countries.

Astellas Pharma Inc has halted enrolment in the trial and patients in the chemotherapy arm will be provided with the opportunity to receive gilteritinib. The company plans to submit results of COMMODORE to the National Medical Products Administration in support of complete approval.