Yesterday evening, Gilead announced that the Data Monitoring Committee (DMC) had recommended early stoppage of the 116 trial, which looks at idelalisib in relapsed/refractory disease in patients who are not eligible for chemotherapy. These patients usually have comorbidities or are elderly and frail, and often receive chlorambucil or rituximab alone. The study compared the combination of idelalisib plus rituximab versus rituximab alone.
Fortunately, the early stoppage was for a good reason – the interim analysis demonstrated a statistically significant improvement in PFS in favour of the combination over rituximab alone. Adverse events were consistent with previous experience of the drug.