Autolus Therapeutics plc (NASDAQ:AUTL) Q4 2022 Earnings Call Transcript

Christian Itin: Really good question, thanks for joining, Matt. What you’re pointing to is really kind of, I think, what we believe was really remarkable data from our initial evaluation of obe-cel in this patient group. Obviously, as you pointed out, what we did see is a stabilization of our long term durability curves, etc., with patients staying in sustained remissions about, as you pointed out, about 35% of patients being in that category, so that is a remarkable outcome and it’s clearly something that has not been possible when developed with Blincyto and has not been shown–clearly not been shown for Tecartus either. What we’re expecting to see with obviously also the FELIX study is that we also see a similar shape of the curve, where exactly that stabilization will ultimately occur.

I think that’s too early to tell – we don’t have enough follow-up in the study at this point in time, but that is what we’re looking for and that is what we expect to see. Whether it’s going to be the exact same level or slightly different level, we do not know at this point in time, and as you pointed out, obviously one of the things that we do have in terms of inclusion into the study is obviously patients that–certainly in that initial data set that we presented, that had pretty significant levels of disease burden as well as extra-medullary disease, which frankly was not too much a surprise given that that first 50 patient data set really was truly peak pandemic, and so we’ll see obviously what the full data set looks like, but we’re obviously expecting to see the same shape of the curve and, at this point in time, we can’t exactly say where that’s actually going to come out.

That requires long term follow-up. The fact that we saw the persistent state had tracked what we had seen before, I think is very encouraging because obviously that was a clear correlation that we did see, that all these patients that had long term outcomes also had long term persistent CAR T cells, and the shape when you look at persistence coming out from the trial, as we had indicated from the interim analysis, was tracking the ALLCAR persistence curve, so that is encouraging. I think it’s the lead indicator, but obviously requires long follow-up to be clear about where we factor we might be landing.

Matthew Phipps: Okay. Can I also ask, at what point do you request the pre-BLA meeting this year? Is that something you do after the ASCO update, or–?

Christian Itin: It’s a really good question. I think what you want to do at the time you go for a pre-BLA meeting is you want to actually have the data with sufficient level of follow-up, so you have a very clear positioning around the outcome that you can actually present and discuss with the agency. Obviously the data we’re going to go with into ASCO, I think will start to give us, I think, a good level of observation, so we would expect that this is going to be an interaction post ASCO.

Matthew Phipps: Okay, great. Thanks Christian.

Christian Itin: Thanks a lot, Matt.

Operator: Thank you. One moment for our next question. Our next question comes from Kelly Shi with Jefferies. Your line is now open.

Kelly Shi: Congrats on the progress, and thank you for taking my questions. Regarding the baseline for patients enrolled in the FELIX trial, does it appear consistent with the Phase Ib cohort of patients with greater than 20% of bone marrow , and also will you be able to provide more information such as patients with and actual medullary disease present on the FELIX trial? Thank you, and I have a follow-up.