Provenge (sipuleucel-T) is an immunotherapy made by Dendreon to treat patients with advanced prostate cancer who have little or no pain. It was approved by the U.S. Food and Drug Administration (FDA) in 2010 to treat asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.

How Provenge works

Provenge is a therapy designed to stimulate an immune response against prostate cancer.

It is produced by first collecting a sample of a population of the patient’s immune cells, called peripheral blood mononuclear cells (PBMC). These cells are then grown in the laboratory and activated with a protein that consists of a combination of a substance called prostatic acid phosphate (PAP) − found only on prostatic cells − and then boosted with an immune protein called GM-CSF.

After activation, the cells are infused back into the patient’s body over a series of treatments, where they are thought to activate T-cells, a type of immune cell. The goal is to stimulate an immune response against prostate cancer cells, thereby killing them.

Provenge in clinical trials

Provenge was the first and remains the only therapeutic cancer vaccine approved for advanced prostate cancer treatment.

The safety and effectiveness of this therapy were initially investigated in early phase trials (Phase 1 and 2), where patients received two infusions of the drug two weeks or one month apart. These pilot studies showed that Provenge was well tolerated, and a small group of patients achieved clinical responses, with declines seen in prostate-specific antigen (PSA). PSA is a protein produced by normal, as well as malignant, prostate gland cells, but which is usually elevated in prostate cancer patients.

Provenge was subsequently investigated in three Phase 3 randomized clinical trials (NCT00005947, NCT01133704 and the pivotal study NCT00065442) with about 500 men, which led to its approval by the FDA on April 29, 2010. 

In 2013, the drug was also approved by the European Medicines Agency (EMA) for the treatment of asymptomatic or minimally symptomatic non-visceral advanced prostate cancer in men with no clinical indication to receive chemotherapy.

In the three trials, patients received three infusions of Provenge or placebo every two weeks.

In the first trial, the time to disease progression (TTP) was favorable to Provenge, although without statistical significance (11.7 weeks vs. 10 weeks with placebo). In a later analysis of this study, it was shown that Provenge significantly improved survival by 4.5 months compared to placebo after three years of follow-up.

The second trial had a similar design. In a combined analysis of all men enrolled in the two trials, a survival benefit of 4.3 months was recorded in patients treated with Provenge, translating to a 33 percent reduction in the risk of death.

In another analysis of this combined data, the use of Provenge was associated with a longer time for patients to need opioids to treat severe pain. There was also a trend toward a longer time to the development of disease-related pain.

The third and largest trial showed a survival benefit of 4.1 months for Provenge compared to placebo, which was statistically significant.

Other studies have been conducted since then of Provenge with other treatments, but these were mainly Phase 2 trials and require additional studies to confirm their outcomes.

Next steps for Provenge

Clinical trials are currently ongoing in the U.S. to investigate Provenge with other cancer therapies, including Bayer’s Xofigo (radium-223, NCT02463799); indoximod (NCT01560923); and Yervoy (ipilimumab, NCT01804465).

Several trials are also studying the effect of radiation combined with Provenge (NCT01807065, NCT01818986, NCT02232230, NCT01833208) at different locations in the U.S.


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