NEXAVAR(R) Proven to Extend Overall Survival by 44 Per Cent
TORONTO, June 4 /CNW/ - Results from a new global study have shown that
NEXAVAR(R) (sorafenib tablets) is proven to extend overall survival in
patients with hepatocellular carcinoma (HCC), or primary liver cancer versus
those taking placebo by 44 per cent. These findings were released today at the
43rd annual meeting of the American Society of Clinical Oncology (ASCO) in
The phase III international, multi centre NEXAVAR trial, called SHARP
Sorafenib HCC Assessment Randomized Protocol, randomized and evaluated liver
cancer patients who had no prior systemic therapy. The primary objective of
the study was to compare overall survival in patients administered NEXAVAR
versus those administered placebo. Median overall survival was 10.7 months in
NEXAVAR-treated patients compared to 7.9 months in those taking placebo.
Canadian trial sites included Calgary, Edmonton, Montreal, Ottawa, Toronto and
"Currently there are no therapies that significantly improve the length
of survival in the thousands of patients with advanced, unresectable
hepatocellular carcinoma or primary liver cancer. These important findings
demonstrate the compelling study results of NEXAVAR as the new standard of
care for the first-line treatment of HCC," said Dr. Jennifer Knox, SHARP trial
investigator, Clinical Oncologist, Toronto.
The study Data Monitoring Committee in agreement with Bayer, halted the
SHARP trial in February 2007, based on a pre-planned interim analysis that
proved an overall survival benefit for NEXAVAR. In the SHARP trial, there were
no significant differences in treatment-emergent serious adverse events
between the NEXAVAR (51.5 per cent) and placebo-treated (54.3 per cent)
groups. The Incidence of Grade 3 and 4 Adverse Events occurring at a higher
incidence (greater than or equal to 2 per cent) in subjects in the sorafenib
group versus the placebo group were diarrhea (11 per cent vs. 2 per cent),
skin reactions in the hands and feet (8 per cent vs. 1 per cent), fatigue (10
per cent vs. 15 per cent), bleeding (6 per cent vs. 9 per cent) and alopecia
About Liver Cancer
Hepatocellular carcinoma is the most common form of liver cancer and is
responsible for about 90 per cent of the primary malignant liver tumors in
adults (1),(2). It is the fifth most common cancer in the world(3) and the
third leading cause of cancer-related deaths globally(4). Mortality rates of
liver cancer in Canada are on the rise, and for 2007, it is estimated that
there will be approximately 1,350 newly diagnosed cases of liver cancer, an
estimated half of which will be fatal(5),(6). Liver cancer is more prevalent
in men than women, with 1,050 new diagnoses in men, compared to 300 in
NEXAVAR targets both the tumor cell and tumor vasculature and is the only
oral multi-kinase inhibitor that does not require patients to interrupt their
In preclinical studies, NEXAVAR has been shown to target members of two
classes of kinases known to be involved in both cell proliferation (growth)
and angiogenesis (growth of new blood vessels) - two important processes that
enable cancer growth. NEXAVAR works by slowing tumour growth and by cutting
off the blood supply to the tumour (angiogenesis). NEXAVAR acts on proteins
called kinases which include RAF kinase, VEGFR-2, VEGFR-3, PDGFR-(beta), KIT,
FLT-3 and RET.
NEXAVAR is currently approved in nearly 50 countries, including Canada,
the United States and in the European Union, for the treatment of patients
with advanced kidney cancer. In 2006, Therapeutic Products Directorate of
Health Canada (TPD) granted a Notice of Compliance with Conditions (NOC/c) for
NEXAVAR for treatment of patients with locally advanced/metastatic renal cell
(clear cell) carcinoma who have failed prior cytokine therapy or considered
unsuitable for such therapy. This authorization reflects the promising nature
of the clinical evidence which will require additional confirmatory data.
Products approved under Health Canada's NOC/c policy have demonstrated
promising benefit, are of high quality and possess an acceptable safety
profile based on a benefit/risk assessment for the approved use. NEXAVAR is
currently marketed in Canada for renal cell (clear cell) carcinoma, however,
the product is not reimbursed by the government. In addition, it is being
evaluated by Bayer, international study groups, government agencies or
individual investigators as a single agent or combination treatment in a wide
range of cancers, including as adjuvant therapy for kidney cancer, liver
cancer, metastatic melanoma, non-small cell lung cancer and breast cancer.
"Although originally approved for use in the treatment of advanced kidney
cancer, HCC is the second tumor type in which NEXAVAR has demonstrated a
clinical benefit," said Dr. Shurjeel Choudhri, senior vice president, head of
Medical and Scientific Affairs, Bayer HealthCare Pharmaceuticals. "We will
continue to conduct a thorough and ongoing clinical program that could bring
the potent cancer-fighting properties of NEXAVAR to an even broader number of
patients in the coming years."
Important Safety Considerations for Canadian Patients Taking NEXAVAR
Based on the currently approved product monograph for the treatment of
patients with advanced kidney cancer, hypertension may occur early in the
course of therapy and blood pressure should be monitored weekly during the
first six weeks of therapy and treated as needed. Incidence of bleeding
regardless of causality was 15 per cent for NEXAVAR vs. 8 per cent for placebo
and the incidence of treatment-emergent cardiac ischemia/infarction was
2.9 per cent for NEXAVAR vs. 0.4 per cent for placebo. Most common
treatment-emergent adverse events with NEXAVAR were diarrhea,
rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea.
Grade 3/4 adverse events were 38 per cent for NEXAVAR vs. 28 per cent for
placebo. Women of child-bearing potential should be advised to avoid becoming
pregnant and women with infants should be advised against breast-feeding. In
cases of any severe or persistent side effects, temporary treatment
interruption, dose modification or permanent discontinuation should be
For Canadian NEXAVAR prescribing information, visit www.bayerhealth.com
or call 1-800-265-7382
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's
leading, innovative companies in the healthcare and medical products industry.
The company combines the global activities of the Animal Health, Consumer
Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare
Pharmaceuticals comprises the following business units: Women's Healthcare,
Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and
Oncology. The company's aim is to discover and manufacture products that will
improve human health worldwide by diagnosing, preventing and treating
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(1) World Health Organization. Hepatitis B. Available at:
Accessed April 10, 2007
(2) Penn State Milton S. Hershey Medical Center College of Medicine.
Malignant Hepatoma. Available at:
Accessed April 10, 2007.
(3) World Health Organization. Estimates by WHO Region: Incidence.
Accessed April 10, 2007.
(4) World Health Organization. Cancer Fact Sheet Number 297. Available
Accessed May 4, 2007.
(5) Canadian Cancer Society. Canadian Cancer Encyclopedia. Available
Accessed May 16, 2007.
(6) Canadian Cancer Society. Canadian Cancer Encyclopedia.
Accessed May 16, 2007.
(7) Canadian Cancer Society. Canadian Cancer Encyclopedia. Available
Accessed May 16, 2007.
For further information:
For further information: Jennifer Acheson, NATIONAL PharmaCom, (416)
848-1708, firstname.lastname@example.org; Michelle Krivel, NATIONAL PharmaCom, (416)
848-1407, email@example.com; Alison Bing, Bayer Inc., (416) 240-5298,