Prostate Cancer advocates continue to press the FDA to approve Provenge by staging marches in Washington and Chicago as well as continuing to add their names to Malecare’s Action Letter. The advocacy has even caught the attention of the major news services, which have been carrying many stories about the efforts of the prostate community.
CNBC, which is covering the annual ASCO meetings (American Society of Clinical Oncology), interviewed John Walker, Interim CEO of Novacea about their experimental drug Ascent-2. Ascent-2 has demonstrated, in a large 900 patient placebo study, that it increases survival rates by 49% while also reducing side effects by 33% when used in combination with Taxotere with men who have androgen independent prostate cancer. The interview become even more interesting when Huckman, who was interviewing Walker asked about the conflict of interest charges that have been leveled at Novacea’s lead researcher, Dr. Howard Scher.
Listen to this interview by clicking this link
ABC World News Tonight has also aired a story about the frustrations experienced by those of us who are androgen independent and had been counting on the FDAâ€™s approval of Provenge.
Watch this video
Joel T Nowak MA, MSW
I should point out, for the sake of accuracy, that in contrast to Joel’s statement above that “Ascent-2 has demonstrated, in a large 900 patient placebo study, that it increases survival rates by 49% while also reducing side effects by 33% when used in combination with Taxotere with men who have androgen independent prostate cancer…” the reality is, as I understand it, that Ascent-2 has not yet even completed enrollment. It was the original Ascent trial (as Phase II trial) that demonstrated the survival rate quote above, but this survival rate did not achieve statistical significance under a log-rank test, coming to p=.07, and needed a Cox regression to get it to p=.04. Survival, of course, was not the primary endpoint either, that primary endpoint being a reduction in biochemical marker, which the study did not achieve significance on by a very large margin.
THAT is the reason Ascent-2 was created, in order to find a large study to see if, in fact, they could get anything like the survival benefit they’d barely shown in the Phase II trial.
This is all unlike Provenge from Dendreon, which showed the survival benefit in Phase III study, first by log-rank, showing 34% alive at 36 months vs. 11% with a log-rank p-value of .01. When Cox regression was used, the p-value shrinks yet further to ridiculously small number.
Just another reason Fleming’s argument comparing Provenge and Ascentar is a complete absurdity. Of course, he’s smart enough to know that, making you wonder why he even said it in the first place…