In hindsight, I think Beartrap and some others are right about the new endpoints additionally meaning it is more likely NWBO is going to additionally try for the rGBM market, and I would argue that the separate rGBM combo trial, which uses Keytruda before and after surgery in the experimental arm, followed by DC + CI and Poly-iclc in both arms, with DCVAx-l treated like the SOC in both arms, will cement this rGBM therapy, whether CI is shown helpful as well or not. So, if you think about it that way, it explains why they’d reprioritize endpoints — not to survive the trial, but instead to springboard from a trial that would have been successful anyway. In other words, the change wasn’t necessary, but instead forward looking — if you will.
Just assume for a moment that researchers are opining, from the compassionate and expanded use arm knowledge, that PFS and OS are “in the bag.” How could you even make a run at rGBM, when it was not an initial goal of the phase iii? This question made me previously doubt folks in the rGBM camp after they saw the new endpoint arrangement.
However, what better order of endpoints, if Original PFS and OS are in the bag, then to wrap in rGBM with the same logic?
In other words, for rGBM, assuming all endpoints below are successful:
Given:
Primary endpoint nGBM = DCVAx against historical SOC nGBM, which was is/was predicted by secondary endpoints ii cPFS and iii (PFS) and v. (tumor response) Annndddd, those secondary endpoints just mentioned also predicted secondary endpoint iv (original OS).
Therefore,
Secondary endpoint i rGBM = DCVAx Against historical SOC rGBM, which is also predicted by secondary endpoints ii cPFS and iii (PFS) and v. (tumor response).
Then add the equivalent of a phase iv. confirmation trial (initial enrollment starting a year ago), in the guise of a combo trial, utilizing DCvAx-l SOC arm w/poly-iclc (something they’ve proven safe in other trials), and compare it to the treatment plus adjuvant (aka: given before and after tumor removal) Keytruda arm.
Very clever and efficient despite the current long phase iii nGBM trial.
Finally, those same predictive type of endpoints in the granddaddy phase iii trial can then be used to make shorter surrogate trials for other cancer indications (We’ve discussed this before). That intellectual property predictive property gained from the granddaddy phase iii trial placing a very effective barrier to entry against competition.
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