GlycoMimetics’ (NASDAQ:GLYC) uproleselan for relapsed and refractory acute myeloid leukaemia (r/r AML) has experts mixed on the likelihood of the drug attaining positive efficacy and safety results in an ongoing Phase III trial.
The differences in perspectives arise in part from a potential amendment to the trial protocol allowing patients pretreated with AbbVie (NYSE:ABBV) and Roche’s (SIX:ROG) Venclexta (venetoclax) to enrol. Experts had benchmarks for clinical success but differed on whether they were reachable. While a source close to the trial said enrolment of patients treated with less intensive therapies such as Venclexta would bode well for Phase III results, other experts said positive results could not be guaranteed for various reasons, including the degree to which patients are relapsed or refractory.
In contrast to positive analyst commentary, most experts were also hesitant on the clinical significance of Phase I/II results, citing major variance in risk factors such as age and cytogenetics among members of the test population. Combined with the uncertainty associated with the potential trial amendment, this led to sceptical expert expectations for FDA approval, despite experts noting the regulatory body has recently been more liberal with AML drug approvals.