I think they had to go with OS for the entire ITT population vs historical norms. They did make a mistake in selecting progression as the primary endpoint, but this is how I think that happened: Both LL and LP lost family members to cancer. I think LL lost her mom to GBM while LP lost her father and sister to other forms of cancer. Those experiences were huge motivators for two very powerful people. Powerful in very different ways, complementing each other. They were very excited about the potential for DCVax and did not think it would be fair to placebo patients to deny them the treatment after progression, so they went with progression as the primary endpoint with crossover to the treatment arm. (Though hard to say how much $ motivation mixed in since progression could allow a shorter, cheaper trial.) But progression turned out to be a poor indicator for an immunotherapy efficacy because progression is detected by expansion perceived as growth while inflammation, which is the goal, initially results in expansion. So they had to fall back on the secondary endpoint, OS. But the crossover complicated OS, lowering the difference in longevity for the initial control patients and the treatment patients. That forced them to go with the entire ITT population with an efficacy watered down by the fact that some patients got the treatment later than optimum. With diluted efficacy, they had to rely on the tendency for immunotherapies to gain on chemotherapies in the very long haul, in this case, over historical norms. And trying to compare to historical norms is very dicey business. Every detail about patients that could come into play has to be catalogued and accounted for to give the submittal any chance of consideration by the FDA, and a distant endpoint would have to be predetermined to add credibility. A distant endpoint, however, aligned with this advantage that immunotherapies have over chemotherapies.
Broadcasting the situation could put patients at risk... maybe. Maybe a reason for silence. I am assuming they really are done now.
