March 31, 2017

Not intended for U.S. and UK Media - American Association for Cancer Research (AACR) 108th Annual Meeting:

Phase II Copanlisib Data Show Durable Tumor Response in Indolent Non-Hodgkin's Lymphoma

Copanlisib achieves objective tumor response rate of 59% in indolent Non-Hodgkin's Lymphoma (iNHL) patients with a manageable safety profile in CHRONOS-1 study / Data to be featured in an oral presentation in a Clinical Trials session on April 4 at AACR / Bayer in discussion with the U.S. Food and Drug Administration regarding a filing for an accelerated approval of copanlisib in follicular lymphoma (FL), a subset of iNHL / Copanlisib granted Fast Track Designation in the U.S. for FL and Orphan Drug Designation in the U.S. for FL and marginal zone lymphoma
Berlin, March 31, 2017 - Bayer today announced positive data on its
investigational compound copanlisib, an intravenous pan-class I
phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory
activity against PI3K-? and PI3K-? isoforms. The Phase II CHRONOS-1 trial, an
open-label, single-arm study of copanlisib evaluating patients with relapsed or
refractory indolent non-Hodgkin's lymphoma (iNHL), met its primary endpoint of
a pre-specified objective response rate (ORR). The results across all patient
groups show an ORR of 59.2%, with a 12% complete response (CR) rate and a
median duration of response (DOR) of more than 98 weeks (687 days). These data
will be presented at the American Association for Cancer Research (AACR) 2017
Annual Meeting in Washington, D.C., USA in the Novel Agent and Intervention
Clinical Trials session on April 4, 2017 from 3:05 PM - 3:20 PM (ET).

"Based on the European Society for Medical Oncology (ESMO) guidelines,
inhibition of the PI3K pathway has been shown to be an effective therapeutic
strategy in treating indolent lymphomas, like follicular lymphoma; however,
concerns exist about the safety of available oral PI3K inhibitors, highlighting
the need for new approaches," said Martin Dreyling, Professor of Medicine at
the University of Munich Hospital in Grosshadern. "The results of CHRONOS-1
demonstrate that intermittent intravenous administration of copanlisib achieved
durable efficacy with a manageable safety profile in this difficult-to-treat
patient population."

The full analysis set comprised 142 patients, of which 141 patients had iNHL.
At the time of analysis, median duration of treatment was 22 weeks and 46
patients remained on treatment. In the follicular lymphoma (FL) subset of
CHRONOS-1 (n=104), copanlisib treatment resulted in an ORR of 58.7%, including
a CR of 14.4% and a median DOR of more than 52 weeks (370 days). The safety and
tolerability were consistent with previously published data on copanlisib. The
most common treatment-related adverse events were transient hyperglycemia (all
grades: 49%/Grade ?3: 40%), which did not show severity above Grade 4 and
hypertension (all grades: 29%/Grade ?3: 23%), which did not show severity above
Grade 3.

"NHL is the tenth most common cancer worldwide and one of the most common
cancers in the U.S. Despite treatment advances, most indolent NHL patients
relapse after, or are refractory to, current therapies," said Robert LaCaze,
Executive Vice President and Head of the Oncology Strategic Business Unit at
Bayer. "The positive results from CHRONOS-1 are an important milestone and
reflect the potential clinical utility of copanlisib in addressing the unmet
medical need in patients with malignant lymphoma."

Other copanlisib data to be presented at AACR 2017 include preclinical analysis
of copanlisib activity in B-cell lymphomas as a single agent or in combination
with conventional and targeted agents and a study on the binding affinity of

Bayer is in discussion with the U.S. Food and Drug Administration (FDA) with
respect to a New Drug Application (NDA), seeking accelerated approval of
copanlisib for the treatment of relapsed or refractory FL who have received at
least two prior therapies. The company has been granted Fast Track Designation
by the FDA for copanlisib for this indication. Fast Track is a program designed
to facilitate the development, and expedite the review of drugs to address
unmet medical need in the treatment of a serious or life-threatening condition.

Copanlisib was also granted Orphan Drug Designation (ODD) by the FDA Office of
Orphan Products Development in the U.S. in February 2015 for the treatment of
FL and in February 2017 for the treatment of splenic, nodal, and extranodal
subtypes of marginal zone lymphoma (MZL). 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. The FDA regards any disease that affects less than 200,000 patients
in the U.S. as rare.


CHRONOS-1 is an open-label, single-arm Phase II study (
Identifier: NCT01660451) evaluating copanlisib as a monotherapy in
non-Hodgkin's lymphoma patients. CHRONOS-1 was designed to evaluate the
efficacy and safety of copanlisib in patients with relapsed or refractory
indolent NHL, including follicular lymphoma (FL), who received at least two
prior therapies. The primary endpoint of CHRONOS-1 is the objective tumor
response rate, with duration of response, overall survival, progression-free
survival, quality of life, and safety serving as secondary endpoints.

About Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma (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. NHL comprises a
highly heterogeneous group of diseases that can be indolent or aggressive with
a poor prognosis. Follicular lymphoma is the most common histological subtype
of indolent NHL, for which there is a need to improve treatment options.

About Copanlisib

Copanlisib is a novel pan-class I PI3K inhibitor with predominant inhibitory
activity against PI3K-? and PI3K-? isoforms, being developed by Bayer. The PI3K
pathway is involved in cell growth, survival and metabolism, and its
dysregulation plays an important role in non-Hodgkin's lymphoma (NHL).
Copanlisib is administered as a 1-hour infusion on an intermittent weekly basis
(3 weeks on/1 week off).

Copanlisib has shown promising clinical activity in Phase I and Phase II
studies in heavily pretreated patients with recurrent indolent and aggressive
NHL. The broad clinical development program also includes Phase III studies in
indolent NHL patients who have relapsed or are refractory to prior therapies.
Information about these trials can be found at and

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

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 includes
three marketed 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.

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the Life Science fields
of health care and agriculture. Its products and services are designed to
benefit people and improve their quality of life. At the same time, the Group
aims to create value through innovation, growth and high earning power. Bayer
is committed to the principles of sustainable development and to its social and
ethical responsibilities as a corporate citizen. In fiscal 2016, the Group
employed around 115,200 people and had sales of EUR 46.8 billion. Capital
expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion.
These figures include those for the high-tech polymers business, which was
floated on the stock market as an independent company named Covestro on October
6, 2015. For more information, go to

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