We are talking about incurable (refractory) cancer cases in which, after treatment, 95% saw either stabilisation or regression of the disease, and 59% showed significant regression or reduction. This is absolutely awesome news.
Note that this trial is an early trial primarily designed to investigate safety of the treatment. Itβs absolutely good news but they need to do a stage 3 trial with a much larger N to convincingly show that it has such a large effect.
As someone who isn't very familiar with how the clinical phase process works, is it fair to say that before Phase 3 clinical trials, companies can cherry pick patients that look like they will respond well to the treatment? and then Phase 3 is more general?
For P1 (which is only to prove safety) this may be the case, but for pivotal studies in P2 and later, participants are almost always randomized so cherry picking shouldn't be possible.
But sure, the study design and primary/secondary endpoints are always levers to increase likelihood of admission. There are often long discussions with the FDA and other regulators on how the endpoints and study population should look like.
