March 05, 2015
Phase III Trial of Regorafenib Shows Insufficient Patient Recruitment
Enrolment will be halted before the study endpoints can be assessed / No new safety signals from studyBerlin, March 5, 2015 - Bayer HealthCare today announced that it is suspending
enrolment into a Phase III trial with regorafenib (Stivarga®) in colorectal
cancer patients with resected liver metastases due to insufficient patient
recruitment. The randomized, double-blind, placebo-controlled Phase III trial
is evaluating regorafenib as an adjuvant treatment of colorectal cancer
following resection of liver metastases with curative intent. As a result of
slow patient accrual, the study will be closed to further enrolment before the
study endpoints can be assessed. Importantly, there were no new safety signals
from the study.
"We are disappointed that the extensive measures to increase recruitment did
not have the desired outcome. We would like to thank the patients and the study
investigators for their contributions and participation in this study," said
Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head
of Global Development. "Importantly, this decision does not affect our
commitment for Stivarga in the approved as well as potential additional
indications. We will continue to evaluate regorafenib in a number of tumor
types with significant unmet medical needs, including colorectal cancer."
Bayer is informing Health Authorities and investigators on the planned
enrolment suspension. The company is actively working with the Data Monitoring
Committee, the Study Steering Committee and investigators with regard to the
appropriate disposition of patients who have entered into the trial. A summary
of the findings will be disclosed to the public as available.
Phase III Trial Design
The COAST (Patients with Stage IV COlorectal Cancer treated with Adjuvant
Regorafenib Versus Placebo after Curative Treatment of Liver Metastases in a
Randomized, Double-blind, Placebo-controlled Phase-III Study) clinical trial is
studying regorafenib in patients with colorectal cancer after curative
resection of liver metastases and completion of all planned chemotherapy. The
study investigates whether providing 160 mg oral regorafenib in the adjuvant
setting increases disease-free survival (DFS) and overall survival (OS)
compared to placebo. From the original 750 patients planned to enroll in the
study, to date about 25 patients have been enrolled.
About Colorectal Cancer
Colorectal Cancer (CRC) is the third most common cancer worldwide, with over
one million cases occurring every year. The five-year survival estimate for CRC
on average is 55 percent, but is highly variable dependent on the stage of the
disease (from 74 percent for patients with Stage I disease to only 6 percent
for Stage IV patients).
About Regorafenib (Stivarga®)
Regorafenib (Stivarga®) is an oral multi-kinase inhibitor that inhibits various
kinases within the mechanisms involved in tumor growth and progression -
angiogenesis, oncogenesis and the tumor microenvironment. In preclinical
studies, regorafenib inhibits several angiogenic VEGF receptor tyrosine kinases
that play a role in tumor neoangiogenesis (the growth of new blood vessels). In
addition to VEGFR 1-3 it also inhibits various oncogenic and tumor
microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET,
PDGFR, and FGFR, which individually and collectively impact upon tumor growth,
formation of a stromal microenvironment and disease progression.
Regorafenib has been approved under the brand name Stivarga® in more than 70
countries worldwide, including the U.S., Europe and Japan, for the treatment of
metastatic colorectal cancer (mCRC). In more than 50 countries worldwide,
including the U.S., Europe and Japan, the product has also been approved for
the treatment of patients with gastrointestinal stromal tumors (GIST).
Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an
agreement with Onyx Pharmaceuticals, Inc., an Amgen subsidiary, under which
Onyx receives a royalty on all global net sales of regorafenib in oncology.
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 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 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
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