April 14, 2015
PI3K Inhibitor Copanlisib in Non-Hodgkin's Lymphoma
Two new Phase III trials to be initiated in patients with indolent non-Hodgkin's lymphoma / One new Phase II trial to be initiated in diffuse large B-cell lymphomaBerlin, April 14, 2015 - 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 and one
additional Phase II study exploring new treatment options for various subtypes
of non-Hodgkin's lymphoma (NHL). Copanlisib is a novel intravenous pan-class I
phosphatidylinositol-3-kinase (PI3K) 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 regulate
many cellular functions, such as growth control, metabolism and transcription
initiation. Copanlisib is one of the company's key pipeline assets currently in
"This is a major step forward in our commitment to exploring the full clinical
potential of copanlisib for patients with NHL," said Dr. Joerg Moeller, member
of the Bayer HealthCare Executive Committee and Head of Global Development.
"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."
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 (ClinicalTrials.gov
- 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
- 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
The new studies add to the ongoing clinical development program for copanlisib,
including several Phase I/Ib studies as well as an open-label Phase II trial
evaluating the efficacy and safety in patients with relapsed or refractory NHL
(NCT01660451). This Phase II study consists of two parts, 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. Part B is an extension of the Phase II study
investigating copanlisib in indolent forms of NHL and is currently ongoing
(CHRONOS-1). Information about these trials can be found at
www.clinicaltrials.gov and www.chronostrials.com.
Copanlisib was recently granted Orphan Drug Designation (ODD) by the FDA Office
of Orphan Products Development (OOPD) in the U.S. for the treatment of
follicular lymphoma (FL), a histologic subtype of NHL. The ODD program provides
orphan status to drugs and biologics which are defined as those intended for
the safe and effective treatment, diagnosis or prevention of rare diseases and
disorders. Orphan drugs are mainly drugs for rare diseases. The FDA regards any
disease that affects less than 200,000 patients in the US as rare.
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 options. 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.
Copanlisib is a pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with
predominant inhibitory activity against both PI3K-? and PI3K-? 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-? and PI3K-? isoforms at sub-nanomolar
concentrations. Copanlisib is administered as an intravenous infusion (over 60
minutes) on days 1, 8 and 15 of a 28-day cycle.
Copanlisib has been evaluated in Phase I and Phase II studies in heavily
pretreated patients with recurrent indolent and aggressive NHL, and has shown
promising early clinical activity in a variety of histological subtypes.
Copanlisib is not approved by the U.S. Food and Drug Administration, the
European Medicines Agency or any other health authority.
More information about copanlisib and the CHRONOS trials can be found on
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
The Bayer Group is a global enterprise with core competencies in the fields of
health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup
of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the
world's leading, innovative companies in the healthcare and medical products
industry and is based in Leverkusen, Germany. The company combines the global
activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31,
2014) and is represented in more than 100 countries. More information is
available at www.healthcare.bayer.com.
Our online press service is just a click away: press.healthcare.bayer.com
Follow us on Facebook: http://www.facebook.com/healthcare.bayer
Follow us on Twitter: https://twitter.com/BayerHealthCare
Find more information at www.bayerpharma.com.