Why Argos will fail to demonstrate any benefit with their lead product, AGS-003 in the phase 3 ADAPT study? Why you ask, so I shall answer.
1) Go to the following publication of phase 2, uncontrolled results with AGS-003 added to sunitinib in 21 intermediate and poor risk RCC patients. What you will note is in Figure 2, the survival graph for the entire population. Pay close attention to the middle line (all patients) and the table below. There are 12 patients alive at month 18. At month 30 (actually at 30.2 months, one patient drops off and defines the median survival for all at 30.2 months)
2) This phase 2 uncontrolled study in a very limited number of patients and cancer centers, was one patient away from a median overall survival of the combination being way closer to the 18 month mark.
Why does this matter?
1) Predicting that AGS-003 is a very safe yet ineffective product when combined with standard treatment. If the one patient succumbed earlier, the survival curve from this study would have looked like you would expect with standard of care treatment.
2) If the IDMC doesn't call the study in February and announce a positive survival benefit, the ADAPT study will simply never be positive. They have 18-24 months of follow up for all patients enrolled onto this study. If there's a difference in survival, it needs to be uncovered and observed now.
3) If the IDMC decides trial continues with the Feb 2017 meeting and indicates that they will convene again later this year or early 2018, guess what? The study is a failure. There will never be a survival advantage.
Employees need to start looking. No readout and a decision to review data late 2017 or into 2018 equals doom. That will suck, but that's the way things go when you have rookies running things.
