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: Anupam Rama - J.P. Morgan - Analyst
: Hey guys, thanks so much for taking the question and congrats on the update here. One for the company and one for the KOLs on the line. For the
company, can you help us understand the placebo performance you're seeing here in SUMMIT Part 2 and any con contributing factors to consider?
I think it's above historical norms if I remember correctly.
And for the KOLs on the line, based on what you know about bezuclastinib and today and non-advanced SM patients, how would you position
the product relative to avapritinib? Is this kind of a head-to-head decision making for a patient or a sequencing type of decision? Thanks so much.
Question: Andrew Berens - Leerink Partners - Analyst
: Hey, thanks and congrats on the first of your three catalysts this year. Definitely think these results set things up nicely for the remainder of the
year. Maybe one for the doc and one for the company, I'm wondering if the KOLs can put the results from SUMMIT into context with what they see
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
Question: Michael Schmidt - Guggenheim - Analyst
: Hey, good morning, thanks for taking my questions and congrats on the positive top line data here. I know the symptom reduction that tear
outcomes are obviously very strong across the board relative to avapritinib, but I was just curious if perhaps there are any particular symptom
domains where bezuclastinib had a particularly strong impact and if you could maybe qualitatively talk about that.
And then, yeah, for the physicians again, just in terms of clinical practice moving forward, just curious, I think you just talk about how to present
new patients with the data, but as you think about patients that are currently receiving avapritinib, in new experience, what percentage of patients
are not well controlled on avapritinib that could be potentially switching candidates as well. Thank you.
Question: Sam Slutsky - LifeSci Capital, LLC - Analyst
: Hey, good morning, everyone. Thanks for taking the questions and great work on today's update. Just kind of a couple of questions for the physicians.
So I've heard from other colleagues of yours that even at the 25 mg avapritinib dose that they do periodic blood work and liver function tests kind
of out of habit.
I guess, are you also doing this and then do the CNS adverse events with avapritinib ever come up in conversation with patients? Do they have
reservations on this? And then just the last question is just how often do patients usually come into the clinic to get checked in with ISM?
Question: David Lebowitz - Citi - Analyst
: Thank you for taking my question. In terms of, the challenges of comparing two different trials, could you discuss the potential impact of the
inclusion of smoldering SM patients and bone marrow mastocytosis patients in the SUMMIT trial versus a trial that only looked at ISM patients?
Question: Kelly Shi - Jefferies - Analyst
: Congrats on the great results. I have two. So first, on tolerability profile, we saw ALT/AST elevation improved from Part 1. Curious if you have noticed
any like a patient the baseline difference from Part 1 or other factors may contribute to this improvement or it was just a small sample size bias
from Part 2? And the second question to do to the doctors, so based on the summit the trial all come from today, what will be the rates through
to Basel's clinical benefit in systematic mastocytosis patients? Thank you.
Question: Kelly Shi - Jefferies - Analyst
: Yeah, that was my second question.
Question: Allison Bratzel - Piper Sandler - Analyst
: Hey, good morning. Thanks for fitting me in. Just, looking at the chart, showing MS2D2 score over time on site 10, it's a little tricky to tell if you're
seeing much in the way of a deepening of symptom response beyond 20 weeks or so.
So maybe just on an individual patient level basis or qualitatively, is that something you saw on the trial and would expect to continue to see
deepening of response over time as treatment duration increases, especially given some of the biomarker data like the data on mast cell burden
reduction? Just hoping you could talk to that.
And then just lastly following up on the recent discussion on bezu, liver safety for the KOLs just based on SUMMIT Part 2 data, would you anticipate
that prescribers will monitor liver function and patients starting the drug and just do you view that as an impediment to prescribing bezu over
other KIT inhibitors? Any thoughts there would be helpful. Thank you.
|