Bayer to Present New Data on Copanlisib in Hematological Malignancies

WHIPPANY, N.J., June 17, 2015 /PRNewswire/ -- Bayer HealthCare will present latest data from its investigational compound copanlisib at the 13th International Conference on Malignant Lymphoma (ICML), June 17-20, 2015, in Lugano, Switzerland. Copanlisib is a pan-Class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against both PI3K-α and PI3K-δ isoforms, currently in clinical development for non-Hodgkin's lymphoma (NHL). The compound is in Phase III development and one of Bayer's key pipeline assets. The expanded global clinical development program now includes two Phase III and two Phase II studies.

Three posters will be presented; two on preclinical data with copanlisib and one trial design poster on the ongoing Phase II trial CHRONOS-1 with copanlisib in patients with indolent NHL.

The following studies evaluating copanlisib from Bayer will be presented with posters at ICML 2015:

Pre-Clinical Studies

• Expression of PI3K isoforms and PTEN in follicular lymphoma and diffuse large B-cell lymphoma
  • Abstract #267, Dr. Soon Thye Lim
• Copanlisib attenuates both BCR-dependent and BCR-independent activation of NFκB in DLBCL cells.
  • Abstract #268, Dr. Juliane Paul

Ongoing Trials

• CHRONOS-1: Phase II trial of intravenous phosphatidylinositol-3 kinase alpha/delta inhibitor copanlisib in patients with relapsed/refractory indolent NHL
  • Abstract #OT07, Dr. Martin Dreyling

The poster session will take place in Marquee Parco Ciani from Wednesday, June 17, 12pm CET to Friday, June 19, 6.30pm CET.

About Non-Hodgkin's Lymphoma 
Non-Hodgkin's lymphoma (NHL) comprises a highly heterogeneous group of chronic diseases with poor prognosis. NHL is the most common hematologic malignancy and the tenth most common cancer worldwide, with nearly 386,000 new cases diagnosed in 2012. It accounts for nearly 200,000 deaths per year worldwide.

Follicular lymphoma is the most common histological subtype of indolent NHL, for which there is a need to improve treatment outcomes. Diffuse large B-cell lymphoma (DLBCL) is the most common histological subtype of NHL and follows an aggressive clinical course, with a median survival of less than one year in untreated patients. Relapsed DLBCL has limited treatment options.

About Copanlisib 
Copanlisib is a pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against both PI3K-δ and PI3K-α isoforms. The PI3K pathway is involved in cell growth, survival and metabolism, and its dysregulation plays an important role in NHL. Preclinically, copanlisib has been shown to inhibit both PI3K-δ and PI3K-α isoforms at sub-nanomolar concentrations.

Copanlisib is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

About the Clinical Development Program for Copanlisib 
The clinical development program for copanlisib in patients with recurrent indolent NHL and DLBCL has recently been advanced and now includes two Phase III studies and two Phase II studies:

• CHRONOS-1: Part B of a larger Phase II study (ClinicalTrials.gov Identifier: NCT01660451) with Part A in indolent and aggressive forms of NHL. Results of Part A of this Phase II study were presented at the the 57th Annual Meeting of the American Society of Hematology (ASH) in December 2014. The extension of the Phase II study investigating copanlisib in indolent forms of NHL is called CHRONOS-1 and is currently ongoing.
• 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). The study was opened for enrollment in May 2015.
• 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 indolent NHL who have received at least one prior line of treatment, including rituximab and an alkylating agent (NCT02367040). Enrollment of the first patient is expected in the second half of 2015.
• 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). The study has been open for recruitment since March 2015.

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

About Oncology at Bayer 
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three marketed oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer HealthCare Pharmaceuticals
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals Inc. provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

BAYER and the Bayer Cross are registered trademarks of Bayer

Forward-Looking Statements  
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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SOURCE Bayer HealthCare Pharmaceuticals Inc.