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Abstract 3066 - A Phase 2 randomized, double-blind study of sipuleucel-T followed by IDO pathway inhibitor, indoximod, or placebo in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), to be presented on Monday, June 5, 2017, 9:00 a.
Sipuleucel-T (Provenge) is such a vaccine, and it is used to treat metastatic prostate cancer.
A priority at Dendreon is to explore the use of sipuleucel-T in earlier stages of prostate cancer and in combination with other agents that may enhance the immune response and patient outcomes.
15] The phase III IMPACT study, in which 512 patients with mCRPC were randomized (2:1) to receive sipuleucel-T or placebo, has shown a survival advantage in the active treatment group (sipuleucel-T, 25.
A further drug sipuleucel-T has also been shown to extend life in the two-year period.
Key Words: Sipuleucel-T (Provenge[R]), metastatic castrate-resistant prostate cancer (mCRPC), therapeutic vaccine.
The Centers for Medicare and Medicaid Services has determined that the evidence supports the conclusion that the prostate cancer vaccine sipuleucel-T, better known as Provenge, is an effective therapy and should be covered for Medicare beneficiaries.
The immunotherapy sipuleucel-T significantly prolonged survival in a study of 512 men with metastatic castration-resistant prostate cancer, confirming the results of two smaller previous trials of this therapeutic "cancer vaccine," according to a report.
Research presented at the AUA meeting in April indicated that an immunotherapy agent, sipuleucel-T (Provenge), can prolong survival in men with advanced prostate cancer that fails to respond to androgen-deprivation therapy.
In March, an FDA advisory panel gave sipuleucel-T the thumbs-up, but the agency decided to delay approval pending the completion of a large trial in men with prostate cancer.
The approval of sipuleucel-T would open a new front on the war on cancer because although it would be the third cancer vaccine approved, it is the first that is therapeutic.
If approved, sipuleucel-T will be marketed as PROVENGE.