What was Lilly Thinking

Pension Fund Thinks Lilly / Imclone Deal Too Cheap

The funny thing is that it is well known that BMS owns the follow-on compound in the US and that ImClone already confirmed as such a couple of years ago. As for the value of the follow-on and the expense to show a meaningful difference between the two antibodies, that is another story and big cost. Someone should do a business case study on this one.

Dendreon: The FDA's Commissioner Doth Protest Too Much!

kelatious-

Are these data from the first phase III or second phase III trial? Were these two percentage statistically different. 33% appears bigger than 11%, but one needs to know the number of patients. I can not remember the exact data, so if you answer these two questions and I will attempt explain subset and why this is so difficult. Thank you.

Dendreon: The FDA's Commissioner Doth Protest Too Much!

I agree with you "echotoall," concerning the tight label. My concern is that we can not identify those who would qualify for treatment as defined by a tight label. I offer a way for Dendreon to identify those patients. By the way it may not be a "biomarker" in the vein of Her2 for Herceptin, it may be a clinical profile. With profile or biomarker(s), the patients who may benefit would be treated, while Dendreon is working on supplemental trial in that subset of a subset of patients. The trial would show if Provenge is actually providing the survival advantage versus the group of patients who would have survived without treatment or the standard treatment.

As for comparing ERBITUX with Provenge, they are not even in the same ball park, but there is one thing that would have been extremely helpful for ERBITUX and that would be having a driven CEO like the one in charge of Dendreon or even Genta. I think their talents and drive are being wasted on compounds destine not be approved, whereas if either had been in charge of ERBITUX, it would have kept the six month lead on Avastin and would have been approved before Avastin and would now be a multi billion dollar drug like Avastin. Not the FDA's falt. It was very poor management at ImClone and even the guys at BMS could not fix the problem even with all their influence, mostly because they did not become of aware of the issues until late in the process. All public information around the time of Martha and her problems.

Dendreon: The FDA's Commissioner Doth Protest Too Much!

The tax paying and insurance paying public wants to be paying for safe and effective medicine. Provenge failed to prove effectiveness several years ago, but did show an apparent activity in a subset of patients. Dendreon then did a second phase III trial in the subset as requested by the FDA. Recently Provenge failed to show efficacy in that subset, but apparently did show efficacy in a subset of the subset. The FDA should now require a third phase III trial to prove that Provenge actually works in the subset of the subset. I would suggest that Dendreon find a biomarker for the subset of the subset of patients, because if they can not identify the subset of the subset of the patients that walk into a doctors office, then their patients will not be able to be identified and I suspect the responsive patient numbers will be under ~10% of the total patient population and Provenge will not be approved. The patients may be unhappy, but there is a background of cancer patients who will actually survive without chemotherapy or immunotherapy, again a group who can not, as yet, be identified, prospectively. So, at the moment, Provenge does not seem to be any better than no treatment or at least the standard treatment, which is not very good either. The author own no cancer vaccine stocks, but does agree that committee members with the stock ownership indicated should not be on the committee for this compound. However, I also think the last advisory committee was incompetent to judge Provenge and I am happy the FDA stuck to their principles.

The Current Status of Cancer Vaccines: An Overview

You might have mentioned that all of the therapeutic cancer vaccines that have reached phase III clinical trials induce an immune response and that to date all of these cancer vaccines have failed to show benefit in phase III in the prospectively selected patient group and have failed to be approved. So far, I have seen nothing that makes me think dendritic approaches will be any more successful. After all Provenge failed its first phase III trial, but in retrospect a subset of patients seem to have benefited, so a second phase III trial was initiated, which failed to show a benefit in the prospectively selected subset of patients from the first trial. However, in the second trial a subset of the subset, seem to show a benefit. Get the point. If you have enough money to run phase III trials eventually you will find a very small number of patients who might benefit, but there is a background of prostate cancer patients and many other cancers who will survive a longer period than the general patient population and if you do not prospectively select patients in a trial you will eventually find these longer survival patients in your treatment arm and your drug will look like it has a survival benefit. All the cancer vaccines have had similar issues during their development, which eventually proved to be of no benefit. I wish companies with the tenacity of Dendreon would move on to find cures for cancer rather than trying to get by with just another immune modulator.