Updated Analysis of Phase III ALSYMPCA Study for Bayer's Investigational Compound Radium-223 Dichloride to be Presented at the 48th Annual ASCO Meeting

WAYNE, N.J., June 4, 2012 /PRNewswire/ -- Bayer HealthCare today announced updated data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial for its investigational drug radium-223 dichloride[*] in men with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases.[1] Radium-223 dichloride significantly increased overall survival (HR=0.695, p=0.00007).⁽¹⁾ The median overall survival (OS) benefit in patients given radium-223 dichloride increased from 2.8 months at the time of the pre-planned interim analysis in June 2011 to 3.6 months in this updated analysis [14.9 months in the radium-223 dichloride group plus best standard of care (BSC) vs. 11.3 months with placebo plus BSC].⁽¹⁾ These and additional data will be presented as a late-breaking abstract in an oral abstract session on June 5^th at the 48^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (LBA No. 4512).

"Bone metastases are one of the main causes of morbidity and death in patients with castration-resistant prostate cancer, yet until now there has been little progress made towards developing therapies that treat the cancer when it has spread to the bone," said Dr. Chris Parker of The Royal Marsden NHS Foundation Trust, London, and The Institute of Cancer Research, London, and principal investigator of ALSYMPCA.

In addition to improving OS, radium-223 dichloride led to a statistically significant delay in the time to first skeletal-related event (SRE) in men with CRPC with bone metastases.⁽¹⁾

The overall safety and tolerability profile for radium-223 dichloride was consistent with previous study results. The most common hematologic adverse events included anemia (31% vs. 31%), neutropenia (5% vs. 1%) and thrombocytopenia (12% vs. 6%) for patients receiving radium-223 dichloride compared to placebo. 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 included bone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs. 15%) and vomiting (19% vs. 14%) for patients receiving radium-223 dichloride as compared to placebo. With respect to Grade 3 to 4 adverse events, the most common events included bone pain (21% vs. 26%).

"These updated survival data with radium-223 dichloride are encouraging and may provide a new treatment option for men who are fighting prostate cancer at its most aggressive stage," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "Radium-223 dichloride is a chief example of Bayer's commitment to researching innovative therapies for diseases where few options currently exist for patients."

ALSYMPCA Trial Design 

The ALSYMPCA trial was a Phase III, randomized, double-blind, placebo-controlled international study of radium-223 dichloride plus BSC compared with placebo plus BSC in patients with symptomatic CRPC that has spread to the bone. The trial enrolled 921 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 six intravenous administrations of radium-223 dichloride or placebo each separated by an interval of four weeks.

The primary endpoint of the study was OS. Secondary endpoints included time to occurrence of SRE, 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 Radium-223 Dichloride

Radium-223 dichloride, formerly referred to as radium-223 chloride, is an investigational alpha-particle emitting pharmaceutical (a pharmaceutical containing an alpha-particle emitting nuclide) in development for CRPC patients with bone metastases.

In September 2009, Bayer signed an agreement with Algeta for the development and commercialization of radium-223 dichloride. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 dichloride globally. In April 2012, Algeta announced that it has exercised its option to co-promote radium-223 dichloride for the treatment of CRPC patients with bone metastases in the United States in accordance to their agreement with Bayer.

Radium-223 dichloride is an investigational agent and is not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or other health authorities. Bayer plans to file radium-223 dichloride with regulatory authorities based on the ALSYMPCA data in the second half of 2012.

About CRPC and Bone Metastases

Prostate cancer is the most common cancer among men in the United States and other developed countries (other than skin cancer).[2] Approximately 15% of prostate cancer cases are considered regional or distant, which means that the cancer has spread beyond the prostate to nearby or distant areas of the body (metastasis).[3] 

A majority of men with CRPC have radiological evidence of bone metastases.[4] 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.[5] Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis.[6] In fact, bone metastases are the main cause of morbidity and death in patients with CRPC.[7]

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare.  The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Bayer^® and the Bayer Cross^® are registered trademarks of Bayer. 

Intended for U.S. media only.

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 

[*] Previously referred to as radium-223 chloride.

[1] Parker C et al. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA) [abstract]. ASCO 2012.

[2] American Cancer Society. Prostate Cancer: Detailed Guide. February 27, 2012. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf. Accessed May 17, 2012.

[3] National Cancer Institute, Surveillance Epidemiology and End Results (SEER). Stage Distribution (SEER Summary Stage 2000); Prostate, All Ages, Male 2000-2008.

[4] Sartor, O. "Radiopharmaceutical and chemotherapy combinations in metastatic castrate-resistant prostate cancer: a new beginning." JCO. 2009;15:2417-2418.

[5] American Cancer Society. Bone Metastases: Detailed Guide. May 3, 2012. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003087-pdf.pdf. Accessed May 17, 2012.

[6] Bone and Cancer Foundation. Questions & Answers about Prostate Cancer Bone Metastases and Treatment-Related Osteoporosis. Available at: http://www.boneandcancerfoundation.org/pdfs/prostate-cancer-qa.pdf. Accessed May 17, 2012.

[7] Lange PH, Vasella RL. "Mechanisms, hypotheses and questions regarding prostate cancer metastatic to bone." Cancer & Metastasis Reviews.1999;17:331-336.

SOURCE Bayer HealthCare