Vicki Goodman: Yes, thanks for the question. So the current STELLAR-303 design did have as a primary endpoint, the overall survival in RAS wild type patients, so to just maybe clarify a little bit of detail there, under the amended design, we will be enrolling patients without regard to RAS status. We will be analyzing the data without regard to RAS status. The change that we’re making is really to improve the probability of success of the trial based on emerging data. So the LEAP-17 data were presented approximately a month ago, prior to that, there were some single-ARM dataset where IO combination including IO/TKI combination, such as regorafenib and nivolumab has been looked at in terms of response rate. And what we’ve seen in small datasets and retrospectively with the patients without liver mets had higher response rates than patients with liver mets.
So what has changed in the LEAP17 data, as we now have a Phase III trial which read out negative for overall survival despite some improvement in response rate and progression-free survival. The OS hazard ratio was 0.83 in the overall population, but the biggest predictor of whether or not there was benefit in the OS — in the subgroup analysis was in patients with or without liver mets, so that the patients without liver mets had a hazard ratio for overall survival 0.65 while those with liver mets, it was 0.91. So we believe that the totality of the data is now and our steering committee and other key opinion leaders, we’ve spoken to also agree that the weight of the evidence supports moving into a non-liver mets population as our primary endpoint.
And so this is what we plan to do, again, with the primary analysis focusing on patients without liver mets and a secondary analysis in all comers which would include patients with liver mets and that ITC and again regardless of RAS status. And again, this is an opportunity for us based on emerging data from external to the trial, and external to our own programs, it really increased the probability of success of the study and make sure that the patients are most likely to benefit from therapy and have an opportunity to do so.
Andy Hsieh: Got it. That’s very helpful. Regarding the tissue factor agnostic opportunity, I’m just curious about how you think about potentially a regulatory strategy there. And also, how big is that tissue factor positive solid tumor opportunity?
Vicki Goodman: Yeah. So at this point, I think it’s too early to talk about our regulatory paths there. This is really an exploratory cohort that gives us an opportunity to look at tumor types that we’re not studying in specific tumor directed cohort. Based on tissue factor expression, it may help us identify other signals for tumor types outside of the ones that we are currently studying. It also may give us some indication on whether tissue factor expression, which we’re looking at across the board in this — in all patients on study, appears to be predictive for response.
Andy Hsieh: Great. And maybe lastly on CBX-12, curious about your view on the data presented at ASCO and remind us what are some conditions for opt-in?
Vicki Goodman: Yeah, so CBX-12 is continuing in dose escalation. We’re certainly encouraged to see responses that have been emerging, the data and the optin decision really, we will have to wait and see in expansion cohorts once we’ve confirmed the activity and the safety profile of the assets.
Andy Hsieh: Okay, great, thank you so much.
Vicki Goodman: Yeah, thank you, Andy.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Jay Olson with Oppenheimer. Your line is open.
Jay Olson: Oh, hey, congrats on the quarter. And thank you for taking the questions. Based on the strong cabo sales, can you just comment on the rationale for keeping the original guidance and what your expectation is for the growth rate for cabo in the second half and maybe just some thoughts on market share at 39%, they had a strong quarter-over-quarter growth, maybe any color on the competitive landscape for TKIs in the RCC market? And then I had a pipeline follow-on, if I could.
