Provenge Immunotherapy Increases Overall Survival in African-American Men with Metastatic Prostate Cancer

Provenge Immunotherapy Increases Overall Survival in African-American Men with Metastatic Prostate Cancer

African-American men with metastatic castrate-resistant prostate cancer survive significantly longer than Caucasian men when treated with Provenge, according to new findings from Dendreon’s PROCEED registry, which is following patients’ outcomes in a real-world treatment setting.

The new results were recently presented at the 112th American Urological Association (AUA) Annual Meeting held May 12-16 in Boston.

Provenge is the only immunotherapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced prostate cancer. The drug works by reprogramming the body’s immune cells to attack advanced prostate cancer cells.

The new results show that African-American patients had extended overall survival when treated with Provenge compared to Caucasian patients (37.3 months vs. 28.0 months). This represents a difference of 9.3 months.

Additionally, looking only at patients with low PSA levels at the time of Provenge treatment, African-American men again showed an extended overall survival of 20.9 months compared to Caucasian men – 54.3 months vs. 33.4 months, respectively.

“These new findings are very encouraging given that African-American men with prostate cancer have a mortality rate more than twice as high as Caucasian men and historically have presented with aggressive disease and have had worse outcomes in both real-world settings and controlled clinical trials,” A. Oliver Sartor, MD, the study’s lead author, said in a press release.

“The fact that we saw an even greater benefit in African-American patients within the lower PSA quartile ranges is also important and provides further evidence that Provenge should be used as early as possible within its labeled indication,” said Sartor, who is the Laborde Professor of Cancer Research in the Departments of Medicine and Urology at Tulane University School of Medicine.

Among the 1,900 metastatic castrate-resistant prostate cancer (mCRPC) patients recruited for the PROCEED registry, 12 percent were African-Americans. The new analysis compared Provenge in a group of 210 African-American men and 420 Caucasian men showing equivalent levels of PSA at baseline.

These findings are in agreement with those of the Phase 3 trial of Provenge (NCT00065442), where a lower baseline PSA level is associated with improved overall survival with Provenge.

“These new PROCEED registry data suggest that patients with asymptomatic or minimally symptomatic mCRPC may benefit the most with early use of Provenge and provide a rationale for immunotherapy as an early treatment strategy in sequencing algorithms for mCRPC,” said James Caggiano, president of Dendreon.

“We are pleased to be able to provide this new clinical data about how metastatic prostate cancer patients respond to and benefit from Provenge in everyday clinical practice,” he added. “It should be useful to urologists and oncologists in supporting treatment decisions for their patients, especially their African-American patients, who typically are more likely to be diagnosed with advanced disease and to have higher mortality.”