All I know is that they will do whatever is possible to give the current trial the best chance for success. I do realize that it possibly means that prior PFS immunotherapy assessments may be "early", if the vaccine induces signs that mimics the pseudo progression condition. If the way to fix it is to change the trial to OS, then they will do it, and use this "iRANO" reason as their justification, which frankly would be valid. Or they may decide to enroll more patients to see if they, at least going forward fix the issue on future assessments. It will depend how many patients they need to add. If, and I say if because this trial is meant to test, overall survival is very strong in this study, but progression free survival is coming in weak and yet there is a large gap between PFS and death, then they can look under the hood to see if they're getting enough immune responses. The FDA would guide on the correct approach.
What I'm not sure about is what caused the chain of events, either the company seeking to use new iRANO on the future imaging and they initiated the screening halt to attempt the pursuit. Meaning no IA was done and the company is trying to add patients so that they can use new iRANO guidelines on a decent percentage of patients, and amend future statistical looks to compensate for possible events that may skew PFS and possibly go for co-endpoint. Or they opt to leave statistical analysis alone and the company is seeking to remove some prior patients from trial analysis, in place of new patients so that they can use new iRANO on a decent percentage of patients. I see that as a possibility. I easily see that regulators would want to review all imaging prior to making their decision. Perhaps regulators will say no more changes, and hence why the company added the new "screening halt may never lift".
Or an IA was done and is showing PFS isn't great, yet OS is good, and the company is trying to use iRANO to support why PFS is not good and amend for a co-endpoint to continue the trial. Perhaps the regulators wanted evidence of all imaging and upon review regulators will agree.
Whatever is happening I just think iRANO change is related to it. I don't know the FDA's response will be. Time will tell.
Okay, need to run, hopefully my post is clear.
