Fred Schwarzer: Yes. We have not decided. We’ll €“ at some point, we’ll be presenting additional single arm data on the FOLFIRI combination. At some point, we’ll presenting additional €“ we’ll be presenting our initial single arm data on the birinapant combination. And at some point, we’ll be presenting our initial single arm data on the venetoclax combination. But we have not made a decision that on when those data disclosures might happen, where we’re still all in progress on all of those studies right now.
Roger Song: Excellent. Thank you, Fred. That’s it for now.
Fred Schwarzer: Thank you.
Operator: Thank you. And our next question is from Joel Beatty with Baird. Your line is open.
Joel Beatty: Great. Thanks for taking the questions. First one is on the DR5 randomized study. How would you define success from that study?
Fred Schwarzer: I think we’ll certainly know it when we see it, but I’m going to leave it to Chris to talk more about what we’ve got in mind.
Chris Takimoto: Yes. So thanks, Joel. Yes. So the study is designed with PFS as the primary endpoint. Obviously, we will be also looking at response rate and overall survival. The reason why we’re really focusing on PFS though is that one that’s much more strongly correlated with overall survival. And at least in the eyes of the FDA is a much more an endpoint, which is €“ has a much higher track record in terms of actually being a registration €“ potential registration endpoint. And as we start to think about now randomized data supporting accelerated approval, that’s really what has led us to design the study in the current way. In terms of what the success look like again, we don’t €“ I never like to give really specific targets, but we €“ our expectation is that if you look at historical second line colorectal cancer data will FOLFIRI control arms for large randomized studies, the PFS tends to be five, six months or so.
And in those studies and things in the not too distant past, so those that that kind of gives you a floor of what we think where we need to be better and where we expect to be substantially better. But that’s kind of the thinking that has gone into the design of the trial.
Fred Schwarzer: Yes. I mean we really are looking for hopefully a significant improvement on PFS over control here, something that’s clinically meaningful, so.
Joel Beatty: Got it. Okay. Sounds great. Thanks for all those details. And then also on the same agent now that you’re focusing more on the 10 milligram dose, is there a risk of seeing some of the liver issues that we’re seeing with other agents targeting €“ the target?
Chris Takimoto: Joel, what I would say is again, based on our monotherapy experience, we did not see any dose related issues. We didn’t see any issues around treatment related liver toxicity in general, and we certainly didn’t see anything that, that emerged at higher doses. So our expectation is that that would not be an issue and it hasn’t been, and we don’t expect it to be an issue in the future.
Fred Schwarzer: Yes. And we dosed, as we said, three patients in combination with FOLFIRI didn’t see anything there. We have dosed some patients in combination with birinapant 10 mg/kg too, and did not see any signal there. So we’re not expecting to see a safety signal a liver hepatotoxicity signal. But I guess that’s why you do the study, but not expecting it.
