Ernie Rodriguez: All right. That’s helpful. Thank you.
Operator: Our next question today comes from Brad Canino from Stifel. Your line is now open.
Brad Canino: Thanks and good morning. Maybe on the CDK2, I’d like to ask if over the past week have any more patients completed eye exams, particularly the patient that had the Grade 3 event and have those results been consistent with what you previously saw? And then if you can just quickly walk through the current thinking of why those vision events are unlikely to impede the full development of this asset and the logistical steps to reactivate this trial? Thank you.
Kate Haviland: Thanks for the question. Becker, will you pick up?
Becker Hewes: Yes. So with respect to the question on the eye exams for the patient with the Grade 3, and this really applies to all of the patients that we have full eye exams on. There’s really absolutely nothing abnormal showing up on these ophthalmologic exams and they’re very extensive ophthalmologic exams. And I think this is really consistent also with the symptomatology, which are – which are very brief episodes of either changing of the intensity of light or a bit of blurriness. Patient with a Grade 3 also had an MRI showing that there was nothing in the central nervous system that could explain the symptoms. But it’s really the really brief nature of the symptoms and the fact that they resolve so quickly upon either briefly stopping the drug and then restarting at a lower dose.
So – and then with respect to the time line or the steps needed to get the program back on track, we’ve been working very closely with the FDA, who’ve been extremely cooperative. The main reason, as we said for the partial clinical hold is simply to modify the protocol to put ophthalmologic specific dose adjustment criteria in there and grading criteria and then to change the informed consent so that everyone is aware that these are potential things that could occur. And then in terms of how I’m thinking about this in the overall development. As we’ve said before, we’re nearing the end of dose escalation. I think we have a range of potential doses available. And so we see the end of the single-agent dose escalation insight. These events, again, are very brief.
They are usually Grade 1, and they – having some ophthalmologic or visual changes in many cancer drugs it’s really not uncommon. And this is so mild and so transient that I really don’t see this as potentially dose limiting. And again, with a drug that has such a clean kinome and it’s so targeted to CDK2. I think we have a good range where we can see potential in the future for clinical benefit for patients.
Brad Canino: Great. Thanks for the color.
Operator: Our next question comes from Eun Yang from Jefferies. Your line is now open.
Eun Yang: Thank you. So we are awaiting details on the PIONEER data at Quad AI, but I wanted to ask you for this key secondary endpoint responder rate, what’s the minimum delta between the 2 arms needed to achieve statistical significance? Thank you.
Kate Haviland: Yes. Thanks for the question, Eun. And I’m going to hand over to Christy to talk more about that.
