ERYTECH Pharma S.A. (NASDAQ:ERYP) Q2 2019 Earnings Conference Call - Final Transcript
Sep 18, 2019 • 08:29 am ET
[Operator Instructions] Our first question comes from Boris Peaker with Cowen. Your line is open.
Good morning. My first question is on TRYbeCA1. I'm just curious for the interim analysis, because what would you need to show for the study to stop for efficacy? And also, is there a futility look there that if you don't have enough separation that potentially the study could be stopped?
This is a question for Iman.
Hi. The study -- that interim analysis does not have a futility component. So it's binary -- it's basically is the agency will look at the data if there is an enough evidence of advantage in terms of the hazard ratio, then the study will be stopped for efficacy. Otherwise, the agency would recommend to continue the trial until completion. Now to show an efficacy, we are looking at approximately same hazard ratio, similar hazard ratio to the final analysis.
Yeas, so what would that hazard ratio have to be for it to stop for efficacy?
It is what we have provided before, it's around 0.72.
Okay, great. And my second question is on TRYbeCA2 study in triple-negative breast cancer. Just curious, what's the timeline for the data? And also, if successful, can this be a pivotal study or have you discussed that with the FDA to potentially be a pivotal study?
I'll start with the last point. No, we have not discussed this yet with the FDA. As you know, this indication is a new indication for us, so the current goal is to generate a signal of activity that can enable us to move into a Phase III pivotal study. And at that point in time, yes, we'll seek the scientific advice from the FDA and CHMP.
Got you. Okay, great. Thank you very much for taking my questions.
Thank you, Boris.
Thank you. Our next question comes from Lucy Codrington with Jefferies. Your line is open.
Hi there. Just a couple of questions for me. It seems like Princeton timelines have slipped again. Is there any particular reason why we're now not expecting it to come online until 4Q? And then just regarding the TRYbeCA1 interim, do we need to have a certain proportion of US patients included in that interim, given that the recruitment has yet to start in the US? Could that be an issue? Thank you.
Hi Lucy, Gil here, I'll start with the -- with your question and hand over to Iman. So, yes, we will now see in Q4, we hope it's early Q4. But indeed, it's two things. We got the IND approval, which was great because that opens the path; that immediately also allowed us to start the discussions with the sites on contract negotiations and site initiation. So that's one track. But the other track is indeed that we still need to get sort of the approval as we have, it was based on the ARC facility.
Now that everything has been a bit later, we have decided