Important results were released at the recent ASCO GU Meeting of a first-of-its-kind study examining survival outcomes of men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with PROVENGE® (sipuleucel-T) in a real-world treatment setting. This study was not a clinical trial where the environment was controlled, but a registry of men who actually took Provenge as their real-world treatment.
The study was a retrospective analysis of the actual medical and pharmacy claims data from more than 6,000 men on Medicare. The study examined the survival data for the men who had Provenge as well as either Zytiga® (abiraterone acetate) or Xtandi® (enzalutamide), at any point in their treatment regimen. The study showed that adding Provenge to these other treatments reduced the men’s risk of death by 45% and extended median overall survival (OS) by 14.5 months.1
These findings were presented in a poster session at the 2020 ASCO Genitourinary (GU) Cancers Symposium in San Francisco (abstract #42, Poster Session A).
“Based on our analysis of these real-world data, men with mCRPC who had immunotherapy added to their treatment regimen had a significant reduction in the risk of death at three years, regardless of the sequencing,” said Rana R. McKay, M.D., lead study author, and medical oncologist and assistant professor of medicine at Moores Cancer Center, University of California, San Diego. “This magnitude of risk reduction is a compelling finding, and additional analyses are underway looking at other variables that could impact outcomes.”
Based upon the real-world use and survival outcomes associated with the utilization of PROVENGE and oral agents Zytiga or Xtandi in men receiving treatment for mCRPC, the study authors found that:
In mCRPC patients treated with Zytiga or Xtandi, the median OS was significantly higher among men who also were treated with PROVENGE (35.2 months vs. 20.7 months; p<0.0001).
Three-year survival rates were significantly higher in men who received PROVENGE in any line of treatment compared to men who never received treatment with PROVENGE (48% vs. 28%; p<0.0001).
More than 150 variations of mCRPC treatment sequences were identified in the analysis, underscoring the importance of developing a structured approach to managing mCRPC patients.
Further statistical analysis of these treatment cohorts is underway.
“These findings underscore the importance of using complementary MOAs to maximize patient survival outcomes, and highlights the critical role immunotherapy plays in the mCRPC treatment regimen,” said Bruce A. Brown, M.D., chief medical officer at Dendreon. “These real-world data contribute to a growing body of evidence that PROVENGE continues to deliver on its promise of helping men with advanced prostate cancer live longer.”
Historically, there has been a segment of clinicians who have questioned the efficacy, thus the value of Provenge. Their reluctance to recommend Provenge has always been a concern and frustration of Cancer ABCs. When Provenge was approved by the FDA, it had already shown its efficacy in two separate clinical trials.
Provenge is a part of the recommended treatment protocol published by the NCCN, the most reliable guide to treatment protocols that clinicians use. This real-world data should change the clinical practice of all of those clinicians who are still skeptical.
MAKE SURE THAT YOU ASK YOUR DOCTOR ABOUT PROVENGE WHEN YOU BECOME CASTRATE RESISTANT.
