January 20, 2017
Regorafenib from Bayer Granted Priority Review in Japan for the Second-Line Treatment of Liver Cancer
Health, Labour and Welfare (MHLW) has granted priority review to Bayer Yakuhin,
Ltd., Osaka, Japan, for regorafenib in the second-line treatment of patients
with unresectable hepatocellular carcinoma (HCC). Regorafenib was submitted for
marketing approval in HCC in Japan in October 2016. The MHLW grants priority
review to medicines on the basis of their clinical usefulness and severity of
the disease. Regorafenib is already approved under the brand name Stivarga® in
many countries, including Japan, to treat metastatic colorectal cancer and
unresectable and/or metastatic gastrointestinal stromal tumors.
"Liver cancer is one of the leading cancer-related causes of death in Japan.
Nexavar® as the first and only approved systemic treatment for HCC has been a
major advance in this field, but effective second-line treatment options are
urgently needed for patients", said Dr. Joerg Moeller, member of the Executive
Committee of Bayer AG's Pharmaceutical Division and Head of Development. "We
welcome the priority review for regorafenib in Japan as it supports our efforts
to make the compound available as early as possible in the second-line setting
for HCC in Japan."
The regulatory submission for regorafenib is based on data from the
international, multicenter, placebo-controlled Phase III RESORCE [REgorafenib
after SORafenib in patients with hepatoCEllular carcinoma] trial. The trial
investigated regorafenib in patients with unresectable hepatocellular carcinoma
(HCC) whose disease had progressed during treatment with sorafenib (Nexavar®)
tablets. Results showed that regorafenib significantly improved overall
survival (OS) compared to placebo (HR 0.63; 95% CI 0.50-0.79; p<0.001), which
over the trial period represents a 37 percent reduction in the risk of death
for patients who received regorafenib plus best supportive care (BSC) compared
to patients treated with placebo plus BSC. The median OS was 10.6 months in
patients treated with regorafenib, compared to 7.8 months in patients who
received placebo plus BSC. The safety and tolerability was generally consistent
with the known profile of regorafenib, with no clinically meaningful
differences in health-related quality of life (HRQoL) between the regorafenib
and placebo plus BSC groups. Data from the study were first presented at the
18th World Congress on Gastrointestinal Cancer (WCGC) in June 2016 and
published online on December 5, 2016 in the peer-reviewed journal The Lancet.
Regorafenib has also been submitted to the regulatory authorities in the US and
EU for the treatment of second-line HCC.
About the RESORCE trial
The Phase III RESORCE [REgorafenib after SORafenib in patients with hepatoCE
llular carcinoma] clinical trial enrolled 573 patients whose disease had
progressed during treatment with sorafenib. Patients were randomized in a 2:1
ratio to receive either regorafenib or placebo plus best supportive care.
Patients received 160 mg regorafenib once daily or placebo, for 3 weeks
on/1week off, with 28 days constituting one full treatment cycle. The primary
endpoint of the study was overall survival, and secondary endpoints were time
to progression, progression-free survival, objective tumor response rate and
disease control rate. Health-related quality of life was assessed by the
FACT-Hep and EQ-5D questionnaires. Safety and tolerability were also
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and
represents approximately 70-85 percent of liver cancer worldwide. Liver cancer
is the sixth most common cancer in the world and the second leading cause of
cancer-related deaths globally. More than 780,000 cases of liver cancer are
diagnosed worldwide each year (52,000 in the European Union, 501,000 in the
Western Pacific region and 30,000 in the United States) and the incidence rate
is increasing. In 2012, approximately 746,000 people died of liver cancer
including approximately 48,000 in the European Union, 477,000 in the Western
Pacific region and 24,000 in the United States.
About Regorafenib (Stivarga®)
Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple
protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2),
oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor
Regorafenib is approved under the brand name Stivarga® in more than 90
countries worldwide, including the U.S., countries of the EU and Japan for the
treatment of metastatic colorectal cancer (mCRC). The product is also approved
in over 80 countries, including the U.S., countries of the EU and Japan, for
the treatment of metastatic gastrointestinal stromal tumors (GIST). In the EU,
Stivarga is indicated for the treatment of adult patients with mCRC who have
been previously treated with, or are not considered candidates for, available
therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy
and an anti-EGFR therapy, as well as for the treatment of adult patients with
unresectable or metastatic GIST who progressed on or are intolerant to prior
treatment with imatinib and sunitinib.
Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an
agreement with Onyx, now 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 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.
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 2015, the Group
employed around 117,000 people and had sales of EUR 46.3 billion. Capital
expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 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 www.bayer.com.
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