AstraZeneca PLC (NASDAQ:AZN) Q2 2023 Earnings Call Transcript

Page 8 of 19

Andrew Baum: Thank you. So, couple of questions. One for Susan and one for Marc. So you filed or you plan to file the TROPION-Lung01 data with the FDA. Can I ask, which population presumably, given you’ve got modest PFS, the OS is a mature. One would imagine that the sub group in the second line that is persuadable third line for the FDA. So, could you just comment on, which indication you are speaking, which population, is it third line, second line, histology knowing the likely response, but I’m interested anyway. And then second to Marc in relation your amyloid monitor, where we share enthusiasm. When we think about the outcome trial, are you going to mirror that that to bridge bio with a sort of embedded six-minute work as well as an outcome for mortality or will be what have — or do you think you can get it approved solely on six-minute work in order to expedite the danicopan market?

Marc Dunoyer: Susan, do you want to start?

Susan Galbraith: Yes, sure. Thanks for the question, Andrew. So obviously, in the top line results, we’ve not specified performance by patient subsets, that’s entirely in line with our normal practice. TLO 1 was stratified by the most immediate prior therapy, including anti-PD-L1 or PD-1 immunotherapy, geographical region, histology, squamous versus non-squamous. It did include patients with actionable genomic alterations so that was a later protocol amendment, and it’s a minority of the patients that are included. I can’t really comment on ongoing dialogue with the FDA at this point.

Pascal Soriot: Maybe the one thing that we could add here is that, from what we’ve seen, I think this agent is going to be useful in a large population of lung cancer patients. Marc, do you want to cover the second question?

Marc Dunoyer: Yes. Thank you, Andrew, for your interest in 2220. So we are planning this Phase III, and we are in ongoing discussion with the FDA to confirm the protocol. You ask a very precise question on whether we were going to include the six-minute working cash in our endpoints. And the answer is no. we are probably going to finalize the endpoints on mortality and cardiovascular morbidity, possibly with the addition of the third tier endpoint, but it won’t include 6-mintute walking distance.

Pascal Soriot: Thank you, Mike. Mark Purcell, Morgan Stanley. Mark, go ahead.

Mark Purcell: Thanks very much, Pascal. A couple of questions. Firstly, on Calquence and one for Dave. Dave, could you help us understand the sales split for Calquence and for the BTK market in CLL between first-line and second line to refractory patients? And if you can help us on the second line side to understand the sort of share dynamics there that could be really useful. Secondly, on the TROPION-Breast01 market opportunity, obviously, a large number of patients, I guess, in the — just the third line setting loan, 85,000 patients in the G8. Could you help us understand how this fits within HER2 and the HER2 low setting as well. So trying to think about the market opportunity before you get the data themselves. And then lastly, for Susan, just to follow on towards TROP-2 testing questions.

Could you help us understand going forward, the importance of TROP-2 testing for TROP-2 ADCs. And from a regulatory standpoint, the acceptance of retrospective data on TROP-2 expression and the potential to incorporate TROP-2 testing into trials, which have recently started such as TL07 and TL08? Thank you very much.

Pascal Soriot: Dave?

David Fredrickson: Yeah. Thank you, Mark for the question. So starting first with your Calquence question. In terms of just the overall new patient starts within the BTKI class, we see about half of new patient starts of total BTK starts are happening in CLL in the front line. And then you have about half of those starts that are happening in the relapsed/refractory setting. And then you can split that half in the relapsed/refractory setting into about half of those, so 25% are in patients who are naive. And the other balance of that is in patients that have been pretreated with BTKI. So that gives you a general sense for how the class splits out. In terms of our share of those classes. I’ve been very pleased with the US performance in the second quarter as we’ve seen in the frontline setting.

Page 8 of 19