The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Eliana Rachel Merle - UBS Investment Bank, Research Division - Analyst
: Just in terms of safety, could you elaborate a bit on the QTc elongations seen in 1 patient as well as sort of the liver elevation seen
in 1 patient that were Grade 3?
And then just in terms of the planning for the Phase III, could you talk a little bit about how you're looking at the AMEERA-3 data as
well as the data from Radius? And any implications in terms of your trial planning?
Question: Matthew W. Luchini - BMO Capital Markets Equity Research - Analyst
: Thank you so much for taking the questions and for providing a nice update this morning.
I guess, first for me, as it relates to the combo -- the Phase Ib combo study you're going to be starting next year. I was just curious if
you have any sense as to, I guess, first, when we might expect some initial results from that study. But I guess more generally, you've
talked about maybe looking at CDK2, CDK2/4/6, if there's any of these mechanisms that you think might be particularly synergistic
with 471?
And then on the data presented today, I was just hoping you might be able to provide or remind us with some additional color as
it relates to both the 2 patients who have had, I think it's now north of 18 months of treatment, as well as the patient that achieved
a partial response with the -- despite having liver metastases since that certainly is an interesting result given the patient population.
Question: Maneka Mirchandaney - Evercore ISI Institutional Equities, Research Division - Analyst
: I actually just had a couple of quick clarifications. The first one is aside from the Grade 3 QTc event that you guys flagged, just wanted
to double check that there weren't any Grade 1 or 2 QTc prolongation or bradycardia type event?
And then on the 2 additional confirmed PRs from the prior cut, from what I can tell, I think one of those was the previously unconfirmed
patient as of the December 2020 cutoff and then one is a new patient. But I just wanted to clarify that that's correct as well.
Question: Tyler Martin Van Buren - Cowen and Company, LLC, Research Division - Analyst
: I guess the first one is what do you view to be the most significant safety and tolerability benefit relative to Sanofi's amcenestrant
as we think about you both eventually competing in the market? And then just secondarily related to the Emerald data, can you just
discuss why you think the PFS and CBR rates were higher in mutant patients versus wild type?
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