PROVENGE (meets endpoint) V/S ZYTIGA( trial discontinued) - WHAT U MUST KNOW-
The pharmaceutical industry is a highly competitive field, and the players come out of their corners fighting full force when the stakes are high. Currently, two competitors in the arena for the metastatic hormone resistant prostate cancer market are Provenge (sipuleucel-T) and Zytiga(abiraterone), but the competitors are not evenly matched.
First of all, the two drugs are not in the same drug class: Provenge, made by Dendreon, is a form of immunotherapy, and it is the only drug for advanced prostate cancer that can make this claim. It is sometimes referred to as a vaccine for treatment of prostate cancer and is also the only immunotherapy drug approved by the Food and Drug Administration (FDA) for treatment of advanced prostate cancer.
Zytiga also has a unique quality in that it is the only hormone therapy drug that stops hormone production in three sites: the testes, adrenal glands, and the prostate tumor itself. Other hormone therapies for prostate cancer are capable of interfering with hormone production in the first two mentioned sites only.
The maker of Zytiga (Johnson & Johnson) recently announced that it was stopping its latest drug trial because the drug had (1) demonstrated good control of prostate-specific antigen (PSA) levels (which is an indicator of disease progression), and (2) shown a trend for an overall survival benefit. While the first factor is significant, the second is not because the trial results did not demonstrate a statistically significant improvement in overall survival, which was one of the two main endpoints of the study.
Why is this important? Because J&J indicated that the Zytiga trial had been a success, yet according to the rules regarding medical trials, all defined endpoints- regardless of how many there are- must be statistically significant before a trial can be deemed a success.
That's not to say that Zytiga is not an effective drug for treatment of late-stage prostate cancer - that remains to be determined. However, it a