RE:RE:Full report from Doug Loe The data will come in stages. The types of info that support approval are ORR, DOR, PFS etc (go learn the language of RECIST). Before that we certainly will start to get reports on safety and an efficacy signal as they get something meaningful but that will be on small numbers of patients maybe over several indications and there is no way to construct ORR etc from those. The first stage data (roughly Ph1 part 1) (maybe mid/late 2021 thru to mid 2022) will be 'signals', indicatating if the drug can do what is expected. The 2nd stage (Ph1 part2) data (late 2022) might be the first chance to QUANTIFY that signal and relate it to other drugs for each indication, still slim data for doing that though. At that stage the promising indication can go into expansion trials (Ph2) that's when the meat goes on the bone.
He's only talking about "preferred target" here it makes sense that that particular decision will come at the end (interim) of Ph 1 part 2. If he has to piece together a model he can't do that without certain info in hand such as which indication they are chasing. Like him I like the basket trial approach but it does come with some downsides like a delay in ascribing a lead indication. If they'd just focused on tnbc then we'd know the lead indication from the start but we'd lose some of the benefits of a basket trial. It's highly unlikely they move forward with all 4/5 indications so which indications make it will need to be worked out from the data.
jeffm34 wrote: "We expect to revisit our assumption on preferred target indication for TH1902 once we have Phase I tumor response data to review, probably near end-of-F2022 if the trial commences enrollment in early FQ321 as Thera predicts."
He's not expecting to see tumour response data until the end of 2022?