So, our hypothesis was if patients have a less damaged or a less challenged immune system. Let’s keep in mind standard chemotherapies like taxanes really are detrimental to immune response, especially multiple rounds of it. Our thinking was if we moved to an earlier setting, we could actually, potentially look at whims in areas like ORR and PFS where we were seeing a hint of a signal in appreciated groups. So, we thought in a pretreated group that would expand that opportunity. Now, if that’s actually the case, it’s potentially very important in terms of our registration path because a PFS win would get us to a registration program much, much earlier than OS would because obviously you have to wait for that OS to mature. So what we’re hoping is if we see the a positive signal in PFS, we could move to dual endpoints for the registration program that would give us a win that could potentially be as much as 18 months or later.
Patrick Trucchio: Perfect. Thank you so much.
Matt Coffey: Thanks Patrick.
Operator: Thank you. And your next question will be from Douglas Miehm at RBC Capital Markets. Please go ahead.
Douglas Miehm: Yes, good morning. First question, if you were to take the OS data from the IND.213 and apply it to the currently ongoing trial, when would you expect to start to see maturity of OS data in this in BRACELET-1?
Matt Coffey: Well, I’ll let Tom speak to, the expectations that the last patient put on study was June, 2022. So for PFS the expectation on the control arm is about a six-month medium PFS. So we’ve got all patients out now 12 months beyond that. So I would say that that’s reasonably – we’ll have mature PFS for ASCO. OS we’re starting to see the events now. As I said, the study started 2020 and we’ve got patients who are on study now for three or more years. Last patient was more than a year ago, you would anticipate survival here to be about a year. So we’re anticipating we should have a pretty good idea by San Antonio. What we’re looking for though, Doug is 80% of the event, so it might be an early 2024 event.
Douglas Miehm: Okay, perfect. And then just remind me if you’re allowed to, were patients – the 48 patients equally divided between the three arms, so 16 in each?
Matt Coffey: No, it was 15 on the Paclitaxel, 15 on Pac Pela because we had already had that. The agency wanted to see a three patient safety run in. So, the Pac Pela avelumab had a three patient run in plus 15, so they have 18.
Douglas Miehm: Perfect. Okay, thank you.
Douglas Miehm: You’re welcome.
Operator: Thank you. And at this time, gentlemen, it appears we have no further questions. Please proceed.
Matt Coffey: Thank you operator. And we wanted to thank everybody who participated this morning. We are just a few weeks away for being able to disclose what happened on BRACELET. We’re obviously very excited. And we would encourage anyone who can to participate in our KOL Call the morning of June 5. With that, I’ll say thanks again and have a lovely morning everyone.
Operator: Thank you, sir. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending. At this time, we ask that you to please disconnect your lines.
