Bayer HealthCare expanded its global clinical development program for the investigational oncology compound copanlisib (BAY 80-6946), which now includes two new phase III studies in indolent non-Hodgkin’s lymphomas and one additional phase II study in diffuse large B-cell lymphoma.
Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase inhibitor with predominant inhibitory activity against both PI3K and PI3K isoforms. The PI3K pathway is one of the most frequently altered pathways in cancer and the PI3K isoforms trigger many cellular functions such as growth control, metabolism and transcription initiation.
The three studies will open for enrollment by mid-2015. Copanlisib was recently granted orphan drug designation by the FDA for investigation in follicular lymphoma.
CHRONOS-2 will be a phase III, randomized, double-blind, placebo-controlled study of copanlisib in rituximab refractory indolent NHL patients who have previously been treated with rituximab and alkylating agents (NCT02369016).
CHRONOS-3 will be a phase III, randomized, double-blind study evaluating the efficacy and safety of copanlisib in combination with rituximab versus rituximab monotherapy in patients with relapsed iNHL who have received at least one prior line of treatment, including rituximab and an alkylating agent (NCT02367040).
The phase II, open-label, single arm study will evaluate patients with relapsed or refractory DLBCL with copanlisib and assess the relationship between efficacy and potentially predictive biomarkers (NCT02391116).
