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: Alexa Deemer, MD - Cantor Fitzgerald LP - Analyst
: Awesome, thank you. So this is Alexa on for Eric Schmidt, and congrats on an awesome data update.
So based upon the data that was presented today, is there any reason to even consider the 750 mg dose any further? And if so, how many
more patients or what data are you still waiting for to make the final dose selection decision? Thank you.
Question: Kelsey Goodwin - Piper Jaffray Inc - Analyst
: Hey, good morning, and thanks for taking my question. Congrats on this update. Regarding the depth of response of 750 mg versus 1,500
mg, maybe just walk us through what gives you confidence that this finding in the clear delta that we see will hold up with longer follow-up.
In other words, I guess how much better could 750 get as you follow the patients longer? That's it for me. Thank you.
Question: Tyler Van Buren - TD Cowen - Analyst
: Hey, guys. Good morning. Thanks so much for the presentation. As we think about the dose selection, next quarter, is there a metric that
the FDA is most focused on when discussing dose selection? Like, is it tumor reduction and depth of response, or is it more duration of
response and progression-free survival? And what's your confidence that this differential depth of response is going to translate to DOR
and PFS?
Question: David Nierengarten - Wedbush Securities Inc - Analyst
: Hey. Just a quick question. If you could remind us if there was any difference in discontinuation rates between the lower and higher dose.
Just speaking to the point about safety and tolerability made earlier. Thanks.
Question: Eva Fortea Verdejo - Wells Fargo Securities LLC - Analyst
: Good morning. Congrats on the progress and thanks for taking our question. A quick one from us, just remaining within the tolerability topic.
You discussed a dose response highlighting biomarkers on the TGF-beta side of the mechanism. So I was wondering, could you provide a
Question: Josh Hunt - Stifel, Nicolaus & Company Inc - Analyst
: Hey. Good morning. This is [Josh Hunt] for Steve. Thanks for taking your question and congrats on the data.
If I could just quickly squeeze in two, how are you thinking about providing updates regarding the progress of the FORTIFI-HN01 trial and
then.
Is there anything you can maybe qualitatively say about the comparison and the duration of follow-up between the two data sets?
Question: Danya Ben-Hail - Jonestrading Institutional Services LLC - Analyst
: Hi, I'm calling in for Soumit Roy. Congratulations on the data and thank you for taking our question. Could you explain the lower response
rate observed in patients with CPS higher than 20? Thank you.
Question: Danya Ben-Hail - Jonestrading Institutional Services LLC - Analyst
: Thank you.
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