Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

New Analyses from Phase III ALSYMPCA Trial Presented at ESMO 2012

Published: Monday, October 01, 2012
Last Updated: Monday, October 01, 2012
Bookmark and Share
Radium-223 dichloride (Alpharadin) was significantly superior to placebo in health-related quality of life (QOL) measures.

Algeta ASA has announced that further data and analysis from the phase III ALSYMPCA study of radium-223 dichloride (Alpharadin) in patients with castration-resistant prostate cancer with bone metastases have been presented as two posters at the ESMO 2012 Congress (Vienna, Austria; 28 September - 2 October 2012).

Dr. Gillies O’Bryan-Tear, Algeta’s Chief Medical Officer, said: “These new analyses continue to build our confidence in radium-223 dichloride’s potential for use in the treatment of castration-resistant prostate cancer patients with bone metastases.”

Both posters can be found at www.algeta.com.

Safety of chemotherapy after radium-223 dichloride (Poster 936P)
The first analysis, conducted post-hoc and presented by Dr. Oliver Sartor (Medical Director Tulane Cancer Center, Tulane Medical School, New Orleans, LA, and Principal Investigator for US arm of ALSYMPCA), found that, based on the limited sample size (n=147), hematologic safety profiles for patients receiving chemotherapy after radium-223 dichloride were similar to those for patients receiving chemotherapy after placebo.

The cohort for this analysis consisted of all patients who received chemotherapy after administration of radium-223 dichloride or placebo.

The proportion of patients receiving subsequent chemotherapy was 93/614 (15%) in the radium-223 dichloride group and 54/307 (18%) in the placebo group.

The most common chemotherapeutic agents administered after study drug treatment were docetaxel (n=105), mitoxantrone (n=23), and cyclophosphamide (n=19).

Administering chemotherapy after the study drug had no deleterious effect on patient overall survival (OS).

In the 147 patients from the ALSYMPCA study receiving chemotherapy after study drug, median OS from start of chemotherapy was 15.6 months in the radium-223 dichloride group and 14.6 months in the placebo group (P = 0.663).

Quality of Life assessment (Poster 898PD)
The second, preplanned, analysis, from all 921 patients recruited into ALSYMPCA and presented by Dr. Christopher Parker (Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK, and Principal Investigator for ALSYMPCA), concluded that radium-223 dichloride showed significantly better preservation of quality of life (QOL), with improved functioning and well-being, compared to placebo, as well as confirming previously reported survival and safety endpoints.

Radium-223 dichloride improved the QOL response rate versus placebo (27% vs 18% p < 0.05), and better preserved QOL over time versus placebo (FACT-P: p < 0.05).

QOL was assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EuroQoL (EQ-5D) instruments, both well validated instruments in prostate cancer.

Radium-223 dichloride is not currently approved by the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) or any other health authority.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,900+ scientific posters on ePosters
  • More than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Algeta: FDA Approves Xofigo (radium-223 dichloride)
Xofigo shown in a pivotal phase III trial to significantly improve overall survival.
Friday, May 17, 2013
Algeta’s Partner Bayer Submits Radium-223 for EU Marketing Authorization
Submission to trigger €50 million milestone payment to Algeta.
Monday, April 22, 2013
Updated Phase III Data Confirm Overall Survival Benefit of Alpharadin in Men with CRPC
Submissions seeking marketing approval in US & Europe expected in 2H 2012.
Monday, June 04, 2012
Alpharadin Significantly Improves Overall Survival for CRPC Patients with Bone Metastases
First presentation of full ALSYMPCA phase III data as part of Presidential Session featuring Best and Late-Breaking Abstracts at 2011 EMCC.
Monday, October 10, 2011
FDA Grants Fast Track Designation to Alpharadin
Fast Track designation granted to Alpharadin for the treatment of castration-resistant prostate cancer in patients with bone metastases.
Friday, August 26, 2011
Clinical Analysis of Alpharadin to be Presented at the 2011 Annual Meeting of the American Society of Clinical Oncology
The analysis concluded that the ALP normalization caused by Alpharadin in patients with bone metastases from CRPC was associated with a significant improvement in overall survival.
Monday, June 06, 2011
Algeta Signs Exclusive Agreement with Lumiphore to Access Proprietary Technology to Enhance its Thorium Platform
Agreement aims to strengthen Algeta’s proprietary position around the development of novel tumor-targeted alpha-pharmaceuticals.
Wednesday, October 27, 2010
Algeta and IFE Agree to Collaborate for the Manufacture and Supply of Alpharadin for Future Commercial use and Clinical Trials
Algeta ASA, the cancer therapeutics company, and the Institute for Energy Technology (IFE), the international research institute for energy and nuclear technology based in Oslo, have agreed to collaborate for the manufacture and supply of Alpharadin for future commercial use and clinical trials.
Monday, January 18, 2010
Algeta announces first US Patient Randomized in ALSYMPCA phase III study at Tulane Cancer Center, New Orleans
Algeta ASA, the cancer therapeutics company, announces that the first clinical center in the US, the Tulane Cancer Center, New Orleans, has started randomizing patients in the phase III clinical study of Alpharadin in men with castration-resistant (also known as hormone-refractory) prostate cancer (CRPC) that has metastasized to the skeleton.
Friday, December 11, 2009
Scientific News
BioCision Forms MedCision
The new company will focus on technologies for the management and automation of vital clinical processes.
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Study to Assess Shorter-Duration Antibiotics in Children
Physicians plan a clinical trial to evaluate whether short course anti-biotics are effective at treating CAP in children.
Cancer Gene Predicts Treatment Response in Leukaemia
Study indicates the patients suffering from a lethal for of acute myeloid leukemia may live longer when receiving milder chemotherapy drugs.
Injectable Biologic Therapy Reduces Triglycerides
Study finds first-of-its-kind therapy promising for patients with high triglycerides, cholesterol.
Testing Zika Vaccine in Humans Begins
The first of five planned clinical trials to test ZPIV vaccine in humans has begun.
Combination Therapy Improved Chemoresistance in Ovarian Cancer
The study demonstrates how an existing class of targeted therapies could be used to potentiate the tumor suppression induced by cisplatin.
Gene Therapy for Blistering Skin Disease Shows Promise
Grafting genetically altered skin onto patients’ chronic wounds marks the first time skin-based gene therapy has been demonstrated to be safe and effective in humans.
Alzheimer’s Treatment Moves a Step Closer
Merck scientists have reported the discovery of verubecestat, a structurally unique, orally bioavailable small molecule that has been shown to target the most visible sign of the disease in the brain.
Lynparza Phase III Progression-Free Survival Benefit
AstraZeneca announces results from Phase III SOLO-2 trial designed to determine the efficacy of Lynparza as a monotherapy for ovarian cancer.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!