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Not intended for U.S. and UK Media: Results of Phase III study in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases:
First presentation of full data as part of Presidential Session featuring best and late-breaking abstracts at 2011 European Multidisciplinary Cancer Congress
Berlin, September 24, 2011 - Bayer HealthCare Pharmaceuticals today announced
positive data on its investigational drug Alpharadin (radium-223 chloride) from
the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. The
study met its primary endpoint by significantly improving overall survival by
44% (p=0.00185, HR=0.695) in patients with castration-resistant prostate cancer
(CRPC) and symptomatic bone metastases. All of the main secondary endpoints
were met, including delay in time to first skeletal-related events (SREs).
These data will be presented during the Presidential Session at the 2011
European Multidisciplinary Cancer Congress in Stockholm, Sweden (Abstract No.
1LBA: Presidential Session I: Best and Late Breaking Abstracts, Saturday 24
September, 13.45 (CEST), Hall A1). The 2011 European Multidisciplinary Cancer
Congress is the 16th congress of the European CanCer Organisation (ECCO), the
36th congress of the European Society for Medical Oncology (ESMO) and the 30th
congress of European Society for Therapeutic Radiology and Oncology (ESTRO).
The data showed that patients who were treated with Alpharadin had the
following outcome:
- A median overall survival of 14 months compared to 11.2 months for the
placebo group,
- Median time to first SREs of 13.6 vs. 8.4 months (64% improvement, HR=0.610,
p=0.00046),
- Total alkaline phosphatase (ALP) normalization in 33% of patients taking
Alpharadin vs. 1% of patients on placebo (p<0.001); and
- A 49% improvement in time to prostate-specific antigen (PSA) progression
(HR=0.671, p=0.00015).
The overall safety and tolerability profile for Alpharadin was consistent with
previous study results. The most common non-hematologic adverse events
(occurring in at least 15% of patients) included bone pain (43% vs. 58%),
nausea (34% vs. 32%), diarrhea (22% vs. 13%), constipation (18% vs. 18%) and
vomiting (17% vs. 13%); and the most common hematologic adverse events included
anemia (27% vs. 27%). In respect to Grade 3 to 4 adverse events, the most
common events included bone pain (18% vs. 23%).The trial was halted earlier
this year following a pre-planned interim analysis to offer patients on the
placebo arm treatment with Alpharadin.
"These data are significant because they demonstrate that Alpharadin can
prolong life in patients with castration-resistant prostate cancer and bone
metastases," said Dr. Chris Parker of the Royal Marsden Hospital, London, and
principal investigator of ALSYMPCA. "These results and previous study findings
suggest that Alpharadin, a novel alpha-pharmaceutical, may provide a new
standard of care for the treatment of castration-resistant prostate cancer
patients with bone metastases."
Alpharadin was recently granted Fast Track designation by the U.S. Food & Drug
Administration (FDA). The Fast Track process is designed to facilitate the
development, and expedite the review, of drugs to treat serious diseases and
fill an unmet medical need. Fast Track designation must be requested by the
drug company and can be initiated at any time during the drug development
process. The company plans to file Alpharadin with regulatory authorities in
the U.S. and Europe based on these data
in mid-2012.
ALSYMPCA Trial Design
The ALSYMPCA trial was a Phase III, randomized, double-blind,
placebo-controlled international study of Alpharadin plus best standard of care
compared with placebo plus best standard of care in patients with symptomatic
CRPC that has spread to the bone. The trial enrolled 922 patients in more than
100 centers in 19 countries who were docetaxel ineligible or intolerable or had
failed prior docetaxel therapy. The study treatment consisted of up to 6
intravenous administrations of Alpharadin or placebo each separated by an
interval of 4 weeks.
The primary endpoint of the study is overall survival. Secondary endpoints
include time to occurrence of SREs, changes and time to progression in PSA and
ALP, safety, and impact on quality of life measures.
ALSYMPCA was initiated by Algeta ASA (Oslo, Norway) in June 2008.
About Alpharadin
Alpharadin (radium-223 chloride) is an investigational alpha-pharmaceutical (a
pharmaceutical containing an alpha-particle emitting nuclide) in development
for cancer patients with bone metastases. This compound mimics many of the
behaviors of calcium in the bone to target areas of high bone turnover in and
around bone metastases.
In September 2009, Bayer signed an agreement with Algeta for the development
and commercialization of Alpharadin. Under the terms of the agreement, Bayer
will develop, apply for global health authority approvals, and commercialize
Alpharadin globally, while Algeta retains an option for up to 50/50
co-promotion and profit-sharing in the United States.
Alpharadin is an investigational agent and is not approved by the FDA, the
European Medicines Agency (EMA), or other health authorities.
Alpharadin is a registered trademark.
About CRPC and Bone Metastases
Prostate cancer is the most common cancer among men in developed countries
including the United Kingdom and the United States (other than skin cancer). In
2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000
died from the disease worldwide. Prostate cancer is the sixth leading cause of
death from cancer in men.
CRPC is also known as hormone-refractory prostate cancer (HRPC). A majority of
men with CRPC have radiological evidence of bone metastases. Once the cancer
cells settle in the bone, they interfere with bone strength, often leading to
pain, fracture and other complications that can significantly impair a man's
health. Bone metastases secondary to prostate cancer typically target the
lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause
of disability and death in patients with CRPC.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of
Bayer AG with annual sales of EUR 16.9 billion (2010), 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 and manufacture products that
will improve human and animal health worldwide. Bayer HealthCare has a global
workforce of 55,700 employees (Dec 31, 2010) and is represented in more than
100 countries. Find more information at www.bayerhealthcare.com.
Find more information at www.bayerpharma.com.
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