Bayer Advances Clinical Development Program for Investigational Cancer Drug Copanlisib

Bayer Advances Clinical Development Program for Investigational Cancer Drug Copanlisib

Bayer HealthCare today announced the expansion of 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 (NHL) and one additional Phase II study in diffuse large B-cell lymphoma (DLBCL), an aggressive subtype of NHL.

Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against both PI3K-δ and PI3K-α 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. Copanlisib is one of the company's key pipeline assets currently in development.

"This is a major step forward in our commitment to exploring the full clinical potential of copanlisib for patients with NHL," said Dario Mirski, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.   "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 investigating potential therapies to address the unmet need of patients."

Three new studies will open for enrollment by mid-2015 to investigate the efficacy and safety of copanlisib in patients with recurrent indolent NHL and diffuse large B-cell lymphoma (DLBCL), an aggressive subtype of NHL.  The expanded clinical program will now include:

• CHRONOS-2: 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: 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)
• A Phase II open-label, single arm study in patients with relapsed or refractory DLBCL to evaluate the efficacy and safety of copanlisib and assess the relationship between efficacy and potentially predictive biomarkers (NCT02391116)

Information about the trials can be found at www.clinicaltrials.gov and www.chronostrials.com.

Copanlisib was recently granted orphan drug designation by the FDA Office of Orphan Products Development (OOPD) for investigation in follicular lymphoma, a histologic subtype of NHL.  The Orphan Drug Designation program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the US, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

Copanlisib is an investigational agent and is not approved by the FDA, EMA or other health authorities.

This article was originally published on PR Newswire.