Dendreon today announced findings from a new analysis of its PROCEED registry, which followed men with metastatic castrate-resistant (hormone-refractory) prostate cancer (mCRPC) treated with PROVENGE (sipuleucel-T) in a real-world treatment setting. The analysis found that African-American patients demonstrated an additional median OS benefit of 9.3 months compared with Caucasian patients (37.3 months vs 28.0 months, respectively). Among the group of patients below the median prostate specific antigen (PSA) levels at the time of PROVENGE treatment, African-American patients demonstrated an additional OS benefit of nearly two additional years (20.9 months) compared with Caucasian patients (54.3 months vs. 33.4 months, respectively).
These compelling results were presented today in an oral podium presentation at the 112th American Urological Association (AUA) Annual Meeting in Boston by lead author A. Oliver Sartor, M.D., the Laborde Professor of Cancer Research in the Departments of Medicine and Urology at Tulane University School of Medicine. PROVENGE is the first and only U.S. Food and Drug Administration (FDA)-approved autologous cellular immunotherapy on the market.
“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,” said Dr. Sartor. “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.”
The PROCEED registry enrolled more than 1,900 patients with mCRPC who received PROVENGE between 2011 and 2013 in everyday treatment settings. Of these, approximately 12 percent were African-American. The analysis presented at the AUA meeting compared OS in a subset of African-American patients (n=210) and Caucasian patients (n=420) matched by baseline PSA.
The analysis showed that the median OS was significantly greater in the African-American patients than in the Caucasian patients (37.3 months vs 28 months, p<0.001).i African-American patients also had better outcomes than Caucasian patients when OS was assessed based on the median PSA level (26.8 ng/mL) and by PSA quartiles.i Among those with a PSA level below the median, the OS was 54.3 months for African-American patients vs. 33.4 months for Caucasian patients – a difference of 20.9 months (p<0.001).i A multivariate analysis found that African-American race was an independent baseline predictor of improved OS (p<0.001) following treatment with PROVENGE.
The findings from the PROCEED analysis regarding the full population are consistent with an analysis of the Phase 3 IMPACT registration trial of PROVENGE published in Urology in 2013. In that analysis, a lower baseline PSA level was associated with a greater overall survival benefit with PROVENGE. Among patients with a baseline PSA ≤22.1 ng/mL, the median OS was 41.3 months for those treated with PROVENGE vs. 28.3 months for those in the control arm – an improvement of 13 months.
“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. 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.”
Filed Under: Drug Discovery
