very quiet here...so, fireside chat has come and gone... and no comments here... so perhaps I'll provide my thoughts..
Matt spoke about why ONCY thinks avelumab was subtractive in terms of diminishing T-Cell count (I wonder how long they have known this.??) He then went on to say that this made it easier to run the Phase III, because it would only be a doublet now, with two arms... He then went on to suggest they could add a CPI as a post-approval activity. No sh*t Matt, so why the hell didn't you just get the Ph III underway 5 years ago, be close to approval by now, and then add as many damn CPIs as you would have revenue to cover...ffs
Unsurpisingly, of course the field of treatment for our target patient population has moved on, and in order to capture enough patients will have to wait until they fail prior treatment (CDK4/6 treatment and ADACs), meaning another 9 month wait before the Phase III can even start. From what I heard , this sounds just like standard ONCY delaying tactics, I no longer expect ONCY to move forward with their fabled mBC Phase III... I think they're gonna stall long enough for the Panc trial to take centre stage.
For the Panc Ph III things sound much more encouraging, complete enrollment (go/no go decision) to be made at end of 2024/early 2025. This would be after enrolling 80-100 patients. Kirk Look stated that the total patient population might be around 180, so assuming this trial gets underway in Q1 2024, with the initial stage being complete by Q1 2025, then assuming they are going for OS as the primary end-point (No mention has been made of accelerated approval), I think the earliest we could see a BLA is Q1 2027, with approval coming just before the patents end. This is of course assumes all their ducks line up in a row, and they can get a patrner to fund the trial.
The recent financing suggest to me at least that they are not expecting to partner anytime soon. I don't see any triggers for a SP lift before ESMO 2023, where they will have more Panc data. When they start the PIII for Panc, which should trigger a nice SP rise too, I'm out.