Do you have any concerns about ICT-107 that shows a statistically significant increase in progression-free survival among patients suffering early stages of the aggressive brain tumor type glioblastoma multiforme but fails to hit statistical significance in overall survival for the intent-to-treat population? Given that the OS is the primary end point.
Its always a concern when a drug does not meet its primary endpoint, which is the case of ICT-107 in the initial readout of the phase II trial results.
My purely "gut" feeling is that ICT-107 does prolong survival in certain patients with GBM but only considering the following:
The vaccine when administered must elicit a strong immunologic response. In particular I am still unsure if the product used in the Phase II study was precisely identical in terms of method of manufacture as compared to the Phase I drug. Also, administration very close to the time of chemotherapy could possibly blunt the immune response needed to offer survival benefit.
There may be a lag time ( a "long tail" ) before the full effect may be seen. The problem is that with a disease as aggressive as GBM some patients, unfortunately, will not survive long enough to experience the benefit of what is essential a "slow acting" drug.
The patient's tumor must have the target or targets that match the antibodies or cellular response which are being stimulated by the vaccine. In the case of ICT-107, we don't yet have the analysis of the tumor antigens in the trial and how they correlated with patient PFS or OS.
Because of the "long tail" of the immune system stimulation response ( as noted above ) there may be patients in a particular trial cohort who, indeed, do survive for much longer periods or potentially experience dramatic survival improvement. However, one has to wait much long to document this effect. In these longer term survivors one can then correlate their tumor antigens and level of immune response and use this information to compare with the larger trial population. ......and then possibly use this information in future patient selection. ( part II of the response to follow )
With regards to what I have stated in part I of this discussion, I think it is too early to close the book completely on ICT-107. I believe that further observation of the present survivors ( especially those whose disease has not progressed thus far ) in the phase II study is critical. The best case, arguing for a notable survival benefit would be to witness very long term survival limited mostly or almost exclusively to those on the drug rather than those given "placebo" or other standard of care. That observation may not clearly ultimately fall within the realm of "statistical significance" for the present trial as a whole, but may point towards a high degree of potential clinical relevance. This outcome could be explored in an, appropriately, much larger future study with adjusted patient selection, timing of drug administration and more consistent product manufacturing.
In terms of an investment, I consider IMUC to be very high risk and a speculative stock. However, I am a bit ( but not overwhelmingly ) encouraged by insider buying of the shares recently combined with what I have discussed above.
Recently, I have purchased a small bit of shares at about .93 to .95 as a highly speculative investment.......complete loss of capital a distinct and real possibility, with a much lower probability of multiple gains.
Nhan knows that I follow this SGEN board closely, so he placed his question here knowing that I would see it. Thanks, in advance, for your understanding of the reason for the brief off topic discussion here.