BRACELET Oct resultsLooks like a nice teaser. Some people will be disappointed that these are not the data from a more recent analysis. The abstract for ASCO was submitted in late 2022 and included data up to that point. We will see 6 more months of data in the ASCO presentation and KOL talk.
I think we already had a pretty good idea about these results from the presentations late last year. The October cufoff censored a huge amount of data and yet produced good results in the surrogate endpoints ORR and PFS. Not easy to do given the unusual KM curves associated with immune based therapy. Quite often, the initial clinical signals are very muted until deeper into the timeline (often 6-8m), after which the curves separate and clinical benefit becomes obvious as the patients who benefit emerge from the crowd. This effect is seen in the IND213 trial results (~slide 7 Corporate Presentation). If the Oct censored results are this good, I would expect that the May censored results will be better. These data are not a surprise but, rather, confirmation. I would be very surprised if the updated ASCO and KOL data are not a significant upgrade. A 50% improvement in response and progression certainly confirms the previous trial and justifies moving on to a registration trial. How much better the results get may not change things much....ONCY will run a registration trial and will have to partner. Next up are the ASCO results. Not much to say until we see new results.
cheers, Geneman