Therapy Areas: Oncology
African American Men with Advanced Prostate Cancer Treated with Provenge Live Longer than Caucasian Men, Study Shows
18 March 2020 - - US-based commercial-stage biopharmaceutical company Dendreon Pharmaceuticals has released findings from a sub-analysis of data from its PROCEED registry comparing overall survival in African American and Caucasian men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with Provenge (sipuleucel-T) in a real-world treatment setting, the company said.

When comparing PSA-matched AA men to CAU men with a baseline PSA less than or equal to the median (29.48 ng/mL), AA men in the PROCEED registry demonstrated a median OS of over 4.5 years (54.3 months) versus over 2.7 years (33.4 months) for CAU men an improvement of 20.9 months and a 48% relative risk reduction in death.

The PROCEED registry enrolled nearly 2,000 patients with mCRPC who received Provenge between 2011 and 2014 in everyday treatment settings, and followed them for three years.

Approximately 12% of patients enrolled in PROCEED were AA.

This analysis compared OS in a subset of AA patients (n=107) and CAU patients (n=222) matched by baseline PSA.

PROCEED evaluated the real-world use of PROVENGE in men with asymptomatic or minimally symptomatic mCRPC. These data were published online in Prostate Cancer and Prostatic Diseases (PCAN), a peer-reviewed Nature Research journal.

The publication in PCAN is the first time these sub-group data have been published in a peer-reviewed journal.

PROCEED (NCT01306890) was a multicenter, open-label, observational registry conducted at urology and medical oncology clinics in private practice and academic sites.

PROCEED enrolled 1,976 patients with mCRPC, of whom 1,902 received PROVENGE between 2011 and 2014 in everyday treatment settings. Of these, approximately 12% were African American.

In the entire PROCEED population, patients were followed for a median of 46.6 months.

Their median age was 72 years and their median baseline PSA was 15.0 ng/mL.

The sub-analysis published in PCAN compared OS in a subset of African American patients (n=219) and Caucasian patients (n=438) matched by baseline PSA.

Prostate cancer is the most frequently occurring non-cutaneous cancer among men in the United States and is second only to lung cancer among the leading causes of cancer-related deaths.

In 2020, an estimated 191,930 new cases of prostate cancer will be diagnosed in the United States and 33,330 men will die from the disease.

African American men have the highest prostate cancer incidence rate of any racial or ethnic group in the world.

In the United States, the risk of prostate cancer is 74% higher in black men than non-Hispanic white men.

The incidence of prostate cancer is about 60% higher in blacks than in whites for reasons that remain unclear.

Prostate cancer death rates in blacks are more than double those of every other racial and ethnic group in the United States.

Provenge is the only FDA-approved immunotherapy made from a patient's own immune cells for the treatment of prostate cancer.

More than 30,000 men have been prescribed Provenge, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

Provenge is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of treatments that harness the power of the immune system to extend life.

Dendreon's flagship product, Provenge (sipuleucel-T), was the first FDA-approved immunotherapy made from a patient's own immune cells.

More than 30,000 men with advanced prostate cancer have been prescribed Provenge in the US since 2010. Dendreon also is evaluating the use of Provenge in early-stage prostate cancer, with the hope of curing more men of the disease. Dendreon is headquartered in Seal Beach, Calif.
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