ERYTECH announced that an independent Data and Safety Monitoring Board (DSMB1) completed its third safety assessment of the company's Phase 2b ENFORCE 1 study in acute myeloid leukemia (AML) and that enrollment will continue until completion. The ENFORCE 1 study is a multinational, randomized, controlled Phase 2b trial evaluating the efficacy and tolerability of GRASPA in the treatment of newly diagnosed AML patients over 65 years of age and unfit for intensive chemotherapy. The primary endpoint of the study is overall survival (OS) following a recently approved protocol amendment, changing the endpoint from progression free survival (PFS) to OS.

OS is considered a more robust endpoint in this indication. Two safety assessments had already been performed by an external DSMB when 30 patients and 60 patients were treated in the study with no safety concerns identified. The third DSMB safety review, now with 105 patients treated, again raised no safety concerns.

The DSMB noted that their observations regarding the main endpoints are unlikely to change with the additional patients, although the statistical power should be improved. Based on the DSMB comments, ERYTECH decided to continue enrolment into the trial until completion, which is expected during the first quarter of 2016. Primary results are expected in 2017.