As we get closer to the annual meeting of the American Society of Clinical Oncology (ASCO) — to be held at the beginning of June — the investor community is beginning its annual frenzy of speculation about exactly what new information will be presented at the meeting about development stage and marketed drugs.
We suspect that the average patient may not be fully aware of the rampant hysteria that can overtake some members of the investment community at this time of year, so (for your entertainment) here is a link to a sample piece of hype that we came across this morning — filled with inaccuracies and over-promises.
For starters, in the world of prostate cancer, we don’t expect either Medivation (MDV3100) or Johnson & Johnson (abiraterone acetate) to be presenting major new data at the ASCO annual meeting this year.
The first of the two Phase III clinical trials of MDV3100 (the AFFIRM trial) is fully enrolled, but we aren’t expecting this trial to be completed until late in 2011 at the very earliest. The second of the two Phase III trials of MDV3100 (the PREVAIL study) is still enrolling patients. There is no way that Medivation will have data from either of these two trials to present.
With regard to abiraterone, we already know the result of the trial in men who have progressed after docetaxel-based chemotherapy. It showed a median 4-month survival benefit for the men treated with abiraterone, and the outstanding question is not what new data will be presented at ASCO but whether the U.S. Food & Drug Administration will actually approve this drug in time for Johnson & Johnson to be able to promote its approval to the attendees at the ASCO meeting in the exhibit hall. Again, we don’t expect data from the clinical trial of abiraterone in chemotherapy-naïve patients until very late in 2011 or (more likely) some time in 2012, although this trial (unlike the PREVAIL trial) is fully enrolled.
We would warn patients not to start making treatment decisions on the basis of most of the hyperbole that they may see in the financial media. There are good and reliable sources of information about the actual clinical status of the majority of prostate cancer drugs in development, and if you are in doubt, you can always talk to your doctor. Until a company can complete the necessary Phase III clinical trials and submit information to the relevant regulatory authorities such as the FDA and be given regulatory approval to market the product, the only access to investigational drugs like MDV3100 and abiraterone is through clinical trials.
And for any in the investor community who happen to be reading this article, beware of the type of guidance appearing in the link above. It was written by someone who clearly knows little to nothing about the prostate cancer marketplace.
Now we do expect to see interesting information presented at ASCO this year. There may even be some surprises in the prostate cancer space. We do also expect to see abiraterone get approved for the treatment of men with progressive prostate cancer following treatment with at least one or perhaps two types of chemotherapy. Furthermore, we are optimistic that this approval will come before June 1, 2011. However, we are not expecting data from any other large Phase III clinical trials of development stage drugs for prostate cancer at the this ASCO meeting. On the other hand, between late 2011 and the end of 2013 we are expecting an absolute flood!