Verastem says COPIKTRA demonstrates progression free-survival of 16.4 months

Verastem announced a poster highlighting clinical data from the Phase 3 DUO study evaluating COPIKTRA in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies was presented at the 23rd Annual International Congress on Hematologic Malignancies, which took place February 28 – March 3, 2019, in Miami, FL. COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase, and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, received approval from the U.S. Food and Drug Administration for this same indication in September 2018. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. The accelerated approval was based on overall response rate and continued approval for this indication may be contingent upon confirmatory trials. The randomized, multicenter, open-label, Phase 3 DUO study, compared COPIKTRA versus ofatumumab in 319 adult patients with CLL or SLL after at least one prior therapy. The study randomized patients with a 1:1 ratio to receive either COPIKTRA 25mg twice daily until disease progression or unacceptable toxicity, or ofatumumab, an approved standard of care treatment for use in CLL/SLL, for 7 cycles. The approval of COPIKTRA was based on efficacy and safety analysis of patients with at least 2 prior lines of therapy, where the benefit:risk appeared greater in this more heavily pretreated population compared to the overall trial population. In this subset, the median patient age was 69 years, 59% were male, and 88% had an ECOG performance status of 0 or 1. Forty-six percent received 2 prior lines of therapy, and 54% received 3 or more prior lines. At baseline, 52% of patients had at least one tumor greater than or equal to 5 cm, and 22% of patients had a documented 17p deletion. During randomized treatment, the median duration of exposure to COPIKTRA was 13 months, with 80% of patients receiving at least 6 months and 52% receiving at least 12 months of COPIKTRA. The median duration of exposure to ofatumumab was 5 months. Efficacy was based on progression-free survival as assessed by an Independent Review Committee. Other efficacy measures included overall response rate.
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