Real-World Evidence Shows Adding PROVENGE® (sipuleucel-T) to Advanced Prostate Cancer Treatment Regimen Prolonged Median Survival by 14.5 Months

SEAL BEACH, Calif.--(BUSINESS WIRE)-- Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, today announced publication of an analysis examining real-world survival outcomes in men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with PROVENGE® (sipuleucel-T) and commonly prescribed oral treatments.

The analysis of Medicare claims data from more than 6,000 fee-for-service beneficiaries showed that the addition of PROVENGE to either abiraterone acetate (Zytiga®) or enzalutamide (Xtandi®), at any point in a patient’s mCRPC treatment regimen, reduced the risk of death by 41% and prolonged median overall survival (OS) by 14.5 months.*

The analysis compared first-line treatment with PROVENGE versus first-line treatment with oral agents, including patients who received PROVENGE in the second-line or later, as well as any-line PROVENGE versus any-line oral agents (without PROVENGE), from 2013 to 2017. Findings were published online in the journal Advances in Therapy.1

“Based on our analysis, men with mCRPC who received sipuleucel-T had a significant improvement in median overall survival and reduction in the risk of death at three years, regardless of line of use,” said Rana R. McKay, M.D., lead author and medical oncologist and assistant professor of medicine at Moores Cancer Center, University of California, San Diego. “These data contribute to a growing body of evidence demonstrating the real-world effectiveness of sipuleucel-T in the mCRPC patient.”

Key findings of the analysis include:

  • In Medicare beneficiaries treated with approved mCRPC treatments, the median OS was significantly longer among men who also were treated with PROVENGE (35.2 months vs. 20.7 months in the any-line cohort and 34.9 months vs. 21.0 months in the first-line cohort).
  • Men who received PROVENGE as a first-line treatment had a 44% reduction in the risk of death at three years compared to those receiving oral agents as first-line treatment (adjusted hazard ratio, 0.56; 95% CI, 0.494-0.627). Similar results were observed in the any-line cohort, where there was a 41% decrease in the risk of death at three years in patients receiving PROVENGE versus those receiving an oral agent (without PROVENGE) (adjusted hazard ratio, 0.59; 95% CI, 0.527-0.651).
  • While safety was not a focus of this analysis, first-line use of PROVENGE resulted in fewer emergency department (ED) visits in the first year compared to oral treatments.

“This analysis underscores the importance of using complementary mechanisms of action to maximize patient survival outcomes and highlights the critical role immunotherapy plays in the modern era of mCRPC treatment,” said Bruce A. Brown, M.D., chief medical officer at Dendreon. “PROVENGE continues to deliver on its promise of helping men with advanced prostate cancer live longer and should be considered when making treatment decisions in daily clinical practice.”

Initial results from a univariate analysis of the data were presented in a poster session at the ASCO Genitourinary (GU) Cancers Symposium in February 2020. The analysis was expanded to explore outcomes using a multivariable analysis to evaluate the impact of PROVENGE on overall survival.

About PROVENGE® (sipuleucel-T)

PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. Nearly 40,000 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.


Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

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About Dendreon

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. Nearly 40,000 men with advanced prostate cancer have been prescribed PROVENGE in the U.S. since 2010. Dendreon also is evaluating the use of PROVENGE in early-stage prostate cancer. Dendreon is headquartered in Seal Beach, Calif. For more information, please visit


*Results are based on a retrospective analysis of Medicare Parts A, B, and D claims data (2013-2017). While we have controlled for known differences in the two treatment groups, findings are limited to the population and are observational in nature.

1 McKay, R.R., Hafron, J.M., Ferro, C. et al. A Retrospective Observational Analysis of Overall Survival with Sipuleucel-T in Medicare Beneficiaries Treated for Advanced Prostate Cancer. Adv Ther (2020).


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Source: Dendreon Pharmaceuticals

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