US-based biopharmaceutical firm Verastem has reported positive top-line results from the Phase III DUO clinical trial of duvelisib to treat relapsed or refractory chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
Duvelisib is an investigational, oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma enzymes that reportedly support growth and survival of malignant B-cells and T-cells.
The trial has met the primary endpoint of progression-free survival (PFS) with duvelisib monotherapy demonstrating superiority over an approved standard-of-care treatment, ofatumumab.
A statistically significant improvement in median PFS of 13.3 months was observed, when compared to 9.9 months for ofatumumab, along with a 48% decrease in risk of progression or death.
The randomised DUO trial compared the efficacy and safety of 25mg twice-daily duvelisib, with an initial infusion of 300mg of ofatumumab followed by seven weekly infusions and four monthly 2,000mg infusions in 319 subjects.
Verastem president and CEO Robert Forrester said: “Duvelisib was an important strategic acquisition for Verastem.
“Both of our late-stage trials with duvelisib monotherapy (DUO and DYNAMO) have now achieved their primary endpoints, highlighting the significant potential of duvelisib in the treatment of advanced hematologic malignancies.”
DYNAMO is a single-arm, Phase II monotherapy trial of duvelisib conducted in indolent non-Hodgkin’s lymphoma (iNHL) patients.
In the DUO trial, duvelisib demonstrated a manageable safety profile, which was consistent with that previously established in patients with advanced haematologic malignancies.
Based on these results from the Phase III trial, Verastem intends to file a new drug application (NDA) to the US Food and Drug Administration (FDA) in the first half of next year.