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news.Bayer HealthCare has expanded its global clinical development program for the investigational oncology compound copanlisib (BAY 80-6946) for the treatment of non-Hodgkin’s lymphoma (NHL).
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Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against both PI3K-d and PI3K-a isoforms.
The program now includes two new Phase III trials and one additional Phase II trial exploring new treatment options for various subtypes of NHL.
These three new trials will open for enrollment by mid 2015 to evaluate the efficacy and safety of copanlisib in patients with recurrent indolent NHL and diffuse large B-cell lymphoma (DLBCL).
Under development, CHRONOS-2 is the first 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.
CHRONOS-3 is the second Phase III randomized, double-blind trial evaluating the efficacy and safety of copanlisib in combination with rituximab versus rituximab monotherapy in patients with relapsed indolent NHL who have received at least one prior line of treatment, including rituximab and an alkylating agent.
The program also includes a Phase II open-label, single-arm trial designed to evaluate the efficacy and safety of copanlisib and assess the relationship between efficacy and potentially predictive biomarkers in patients with relapsed or refractory DLBCL.
Bayer HealthCare Executive Committee member and Global Development head Dr Joerg Moeller said: "This is a major step forward in our commitment to exploring the full clinical potential of copanlisib for patients with NHL.
"Non-Hodgkin’s lymphoma is a highly heterogenous disease characterized by a chronic pattern of remissions and recurrences, and for NHL patients with disease recurrence after initial treatment there are limited treatment options.
"Therefore, we are committed to delivering effective and innovative new therapies to address the unmet need of physicians and patients."
The ongoing clinical development program includes several Phase I/Ib trials as well as an open-label Phase II trial evaluating the efficacy and safety of copanlisib in patients with relapsed or refractory NHL.
Recently, the US Food and Drug Administration (FDA) has granted orphan drug designation for copanlisib to treat follicular lymphoma (FL), a histologic subtype of NHL.
Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.