Prof Annette Hay speaks to ecancer at the ASH 2019 meeting in Orlando about accrual barriers and detection of early toxicity signal in older, less-fit patients treated with azacitidine and nivolumab for newly diagnosed acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome (MDS).
Prof Hay says that AML and MDS are typically diseases of older people, yet these patients are poorly represented in clinical trials. This trial deliberately accrued older patients using broad enrolment criteria with the aim of improving outcomes in this patient population.
She reports that, unfortunately, there was a possible early toxicity signal in the azacitidine plus nivolumab arm when compared to the control azacitidine only arm. Prof Hay explains that while these results were not statistically significant, this led to the azacitidine and nivolumab arm being removed from the trial.
Prof Hay concludes by talking about the next steps for the remaining arms of the trial and the challenges associated with including this patient population in clinical trials.