Algeta ASA : Further sub-analyses of ALSYMPCA phase III study presented at 2013 Genitourinary Cancers Symposium
Not Intended for US Media
Abstracts #11 & #19
Effects of radium-223 dichloride on skeletal-related events and pain associated
with bone metastases from castration-resistant prostate cancer
Oslo, Norway, 15 February 2013 - Algeta ASA (OSE: ALGETA) announces that further
analyses of data subsets from the phase III ALSYMPCA study of radium-223
dichloride (radium-223) in castration-resistant prostate cancer (CRPC) patients
have been presented at the 2013 Genitourinary Cancers Symposium (14-16
February 2013, Orlando, FL, USA).
Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "These additional
analyses from ALSYMPCA demonstrate that, in addition to prolonging survival in
CRPC patients with bone metastases, radium-223 also improves clinically relevant
endpoints related to complications from bone metastases. If approved, radium-
223 has the potential to play a key role in the treatment of men with CRPC that
has metastasized to the bone."
Abstract #11 by Vogelzang et al. found that radium-223 treatment significantly
delayed time to first skeletal-related event (SRE) versus placebo by a median
increase of 5.8 months (median time to SRE: 15.6 vs 9.8 months; HR=0.658;
P<0.001). The analysis also showed that, compared to placebo in CRPC patients
with bone metastases, treatment with radium-223 reduced the risk of time to
first event for all four SRE components, including a 48% reduction in risk for
spinal cord compression.
Abstract #19 by Nilsson et al. described an analysis of pain parameters in
ALSYMPCA. The analysis showed that, compared to placebo in CRPC patients with
bone metastases, patients treated with radium-223 had significantly prolonged
median time to first palliative external beam radiotherapy (EBRT) (HR=0.670,
P=0.00117) and in a post-hoc analysis patients treated with radium-223 had
significantly prolonged median time to initial opioid use, with a risk reduction
of 38% compared to placebo (HR=0.621).
In the ALSYMPCA trial the most common hematologic adverse events for patients
treated with radium-223 and best standard of care (BSoC) and compared to placebo
and BSoC included anemia (31% vs. 31%), neutropenia (5% vs. 1%) and
thrombocytopenia (12% vs. 6%). With respect to Grade 3 and 4 adverse events, the
most common events included anemia (13% vs. 13%), neutropenia (2% vs. 1%) and
thrombocytopenia (6% vs. 2%). The most common non-hematologic adverse events in
patients treated with radium-223 and BSoC compared to placebo and BSoC included
bone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs. 15%) and
vomiting (19% vs. 14%). With respect to Grade 3 to 4 adverse events, the most
common events included bone pain (21% vs. 26%).
Abstract #11 - Vogelzang, N. et al. Updated analysis of radium-223 dichloride
(Ra-223) impact on skeletal-related events (SRE) in patients with castration-
resistant prostate cancer (CRPC) and bone metastases from the phase III
randomized trial (ALSYMPCA).
Abstract #19 - Nilsson, S. et al. Pain analysis from the phase III randomized
ALSYMPCA study with radium-223 dichloride (Ra-223) in castration-resistant
prostate cancer (CRPC) patients with bone metastases.
About the ALSYMPCA Trial
The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial was a phase III,
randomized, double-blind, placebo-controlled international study of radium-223
with best standard of care (BSoC) vs placebo with BSoC in symptomatic CRPC
patients with bone metastases. The trial enrolled 921 patients in more than 100
centers in 19 countries. The study treatment consisted of up to six intravenous
administrations of radium-223 or placebo each separated by an interval of four
The primary endpoint of the study was overall survival. Secondary endpoints
included time to occurrence of skeletal-related events (SRE), time to total
alkaline phosphatase (ALP) and prostate-specific antigen (PSA) progression,
total ALP response and normalization, safety, and quality of life.
About CRPC and Bone Metastases
Prostate cancer is the most common non-cutaneous malignancy in men worldwide. 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.
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 morbidity and death in patients with CRPC.
About Radium-223 Dichloride
Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a
therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor
effect on bone metastases in development for CRPC patients with bone metastases.
In September 2009, Algeta signed an agreement with Bayer Pharma AG (Berlin,
Germany) for the development and commercialization of radium-223. Under the
terms of the agreement, Bayer will develop, apply for global health authority
approvals, and commercialize radium-223 globally. Algeta will co-promote radium-
223 with Bayer in the US, and is eligible for milestones as well as royalties on
Bayer's sales outside the US. The ALSYMPCA trial was initiated by Algeta in June
Radium-223 is an investigational agent and is not approved by the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA) or other
health authorities. Bayer submitted a Marketing Authorization Application to the
EMA and a New Drug Application to the FDA for radium-223 in December 2012 for
the treatment of CRPC patients with bone metastases, and received priority
review for the NDA in the US.
In terms of further development activities for radium-223, Bayer intends to
conduct studies in earlier settings of prostate cancer, including combination
studies with other agents, as well as exploratory studies in other tumors such
as breast cancer and osteosarcoma.
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Algeta is a company focused on developing novel targeted therapies for patients
with cancer based on its alpha-pharmaceutical platform. The Company is
headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in
Cambridge, MA performing commercial marketing operations in the US. Algeta is
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This news release contains certain forward-looking statements that are based on
uncertainty, as they relate to events and depend on circumstances that will
occur in the future and which, by their nature, may have an impact on results of
operations and the financial condition of Algeta. Such forward-looking
statements reflect our current views and are based on the information currently
available to Algeta. Algeta cannot give any assurance as to whether such forward
looking statements will prove to be correct. These forward looking statements
include statements regarding our anticipated co-promotion of radium-223 in the
US. Â There are a number of factors that could cause actual results and
developments to differ materially from those expressed or implied by these
forward-looking statements. These factors include, among other things, risks or
uncertainties associated with the ability to identify and hire a sufficient
number of qualified employees for the US field force, growth management, general
economic and business conditions and the pricing environment, the impact of
competition, the ability to successfully commercialize radium-223, the risk that
costs associated with the co-promotion of radium-223 may be greater than
anticipated, manufacturing capacity, the risk of non-approval of patents not yet
granted, risks in obtaining regulatory approvals for radium-223 and the other
risks and uncertainties described in our annual report.
The 2013 Genitourinary Cancers Symposium is co-sponsored by the American
Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology
(ASTRO) and the Society of Urologic Oncology (SUO).
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