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: Peter Welford - Jefferies & Company - Analyst
: I've got a couple but I hope these are very quick. Firstly, did you measure [mis-minimal] residual disease at all in this study? And if
so, can you comment on that? [It's all very -- this] preliminary result that you have.
And secondly, then, I wonder if you can just comment on the lyophilized form. Did that conclude that there is indeed be the
opportunity to have this available as lyophilized or will the final form be a frozen drug?
And then just finally on the duration of treatment, I wonder -- you obviously commented on the median duration of response. I
wonder you can give us an idea as to how long typically patients stayed on drug to give us an idea of that. Because it looks most
patients were off drug by the time the results were presented. Thank you.
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Question: Andrew Baum - Citigroup - Analyst
: A couple of questions. So firstly, to the subject of quality of life, particularly as this drug moves upstream, could you comment on
the impairments of driving ability, given the corneal event rate?
And then second question, which has got two parts, relates to the emergent future competitive environment with bispecific and
CART Ts. It seems as if the agent has a very good durability of response, but the response rate is obviously lower from what we have
seen with (inaudible) modalities in earlier stage trials. So in terms of the GSI combination, there's a problem of thrombocytopenia
with both agents. So I would obviously be worried about the risk of overlapping tox. How is that manageable within this setting?
And then second, you have an ongoing open-label combination trial with your PD-1 with a PD-1, I think it's pembrolizumab. I
understand you've had a set, 10 or so patients enrolled. They are very refractory patients. I realize it's a very small number. But given
how refractory the patient population is, perhaps you might like to share the response rate that you're seeing at this still early stage?
Thank you.
Question: Louise Pearson - Redburn Partners - Analyst
: It's Louise Pearson from Redburn. I've got two, please. Firstly, could you confirm if your application with the FDA might be considered
for an expedited review, whether that's a priority of you or through the FDA's real-time oncology review program? And then secondly,
when might we expect the next analysis of survival or response data from DREAMM-2 to take place? Thank you.
Question: Louise Pearson - Redburn Partners - Analyst
: Sure. It's when might we expect the next analysis of survival or response data from DREAMM-2 to take place.
Question: Steve McGarry - HSBC - Analyst
: A couple of things. Firstly, just on the keratopathy, first of all, when did patients develop the side effect? Was it early or was it -- and
was it cumulative? And in terms of doing discontinuations, was this due to patient reporting, or were the clinicians looking for it
proactively? And lastly on that, just practically, is that likely sort of like what happens in clinical practice, especially as the drug moves
earlier in the treatment paradigm?
And then secondly, just on the gamma-secretase inhibitor, if it's validated clinically, what's the royalty rate (inaudible)? Thanks.
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