Verastem's duvelisib meets in Phase III for CLL

Verastem Inc. (NASDAQ:VSTM) reported top-line data from the Phase III DUO trial in 319 patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) showing that twice-daily 25 mg oral duvelisib (IPI-145) met the primary endpoint of improving median progression-free survival (PFS) vs. Arzerra ofatumumab (13.3 vs. 9.9 months, HR=0.52, p<0.0001). In a subset of patients with the 17p deletion, duvelisib led to a median PFS of 12.7 months vs. 9 months for Arzerra (p=0.0011).

The open-label, international trial’s secondary endpoints include overall response rate (ORR), hematologic improvements, overall survival (OS), duration of response, lymph node response rate, safety and pharmacokinetics...