Question-and-Answer Session
Operator
(Operator Instructions). Your first question comes from the line of Ren Benjamin - Rodman & Renshaw.
Ren Benjamin - Rodman & Renshaw
Starting off with Oncophage, thanks for the review of the clinical data. I thought that the subset analysis actually got split into three groups, with intermediate being one of them and then a high-risk group and a much lower risk group. If that’s the case, can you give us an idea as to how the curves have done in the lower and high-risk groups as well?
Dr. Garo H. Armen
I think what you’re referring to Ren is the ECOG definition. ECOG definition includes low risk, intermediate risk, and high risk, but patients enrolled in our trial have been in intermediate risk and high risk. We haven’t had low-risk patients, and the reason for that is as you remember I remarked that this has been one of the longest trials in studying a cancer drug. If we had included low-risk patients, instead of it being an 8- to 10-year trial, which would have been a 15- to 20-year trial. That would have rendered it very impractical to complete, and that’s why we’ve taken the low-risk patients out at the start of the trial, but when we started the trial and designed the trial, the adjuvant patient population which comprised of both staging and grading criteria were lumped in one group because it was thought that they had a risk of approximately 50% chance of relapse. And then subsequently when ECOG designed their trial in 2006, they redefined populations of renal cell carcinoma based on the latest prognostic criteria, and certainly the field had advanced by then between 2000 and 2006, and this is a field that’s continuously evolving in many other cancers in terms of staging and grading and classification of these patients. So if apply the ECOG criteria to classify patients in our trial, they fell into two groups, intermediate risk and high risk. Now, if you look at for example the old staging, we had patients with stage I and II high grade tumors and stage III low grade and high grade tumors, and stage IV non-metastatic patients. That comprised the entire patient population in our trial. If you looked at by prospectively defined staging, we still see the same trend. In other words, the trend that you see in intermediate risk curves are the trends also present in stage I and stage II high-grade patients but because we did not have the numbers of patients, the results were not yet statistically significant in those populations. When you add the additional patients defined in the ECOG trial, then the results become statistically significant, and as I remarked, yes, this is a subset analysis; however, it is a subset that is externally defined, and that is one of the reasons a key group of advisors that number in several dozens, well-known prominent physicians around the world, are very supportive of this particular analysis, and that includes also very well known globally well known world-class biostatisticians who are on board with this analysis because of the biological rationale. So there is a lot of concordance between the ECOG subgroups that I defined versus the older subgroups that were included in our prospective analysis.
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