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

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And we’re comfortable with the safety profile that we’ve seen across that patient population. So I think it’s important to just remember that from an ILD perspective, we know that some tumor types have a higher risk of ILD than others and that later line patients, you’ve had multiple prior lines of chemotherapy or high risk of ILD. And so I think it’s important that that ongoing safety profile that in first-line lung is underpinning our confidence there. When you look at TROPION-Lung02 data that you highlighted, we’re encouraged both by the response rate and the durability of response that we’re seeing from TROPION-Lung02 for both the combination with the doublet of Dato-DXd plus pembro and also the triple when platinum-based chemotherapy is added.

What you’ll see in TROPION-Lung04 is that’s a Phase Ib study that also looks at the combination of data plus immune checkpoint inhibition in cancer. So, it’s an additional data set to TROPION-Lung02. And again, we’re happy to talk to you after the data presented at a World Congress on lung cancer. For breast cancer, you asked 2 questions. One is about TROPION-Breast01. Again, the confidence in TROPION-Breast01 is based on the data that we’ve seen that you’ve already highlighted and you’ve already mentioned. I mean, I’ll just say that for the design of Dato-DXd, we think is a best-in-class ADC. It’s got excellent stable linker and a proven roll head already. And so when we look across cross-track comparisons with all the caveats those have, and we’ve seen numerically higher response rates across a number of different settings and that really underpins our potential to have better efficacy and have a best-in-class profile in that setting.

But, obviously, we have to wait for the actual readout of the trial. For DESTINY-Breast09, I think actually, the readout turns not — it’s hugely shifted here. Obviously, all of the — and HER2 trials are accruing rapidly and that helps with the time lines, but these are also event-driven trials that we look for the outcome. So I don’t think there’s anything more than that to insert in the shift in the timeline. I hope that addresses all your questions.

Pascal Soriot: Thanks Susan. Tim Anderson. Go ahead, Tim.

Tim Anderson: Hello. Great. Thank you. So just staying on the topic of Dato-DXd in the light of what TROPION-Lung01 has shown. I know you guys say you’re enthusiastic much program. Is your enthusiasm less or tempered at all by how TLO1 read out because the benefit — I mean, you guys pretty much said is modest. So, I’m wondering if that those kind of temporary expectations for that program overall, what that could deliver in other tumor types or even other settings for lung cancer. And then a second question, where are you with the retrospective biomarker analysis of TLO. Is there anything you can say yet within results by TROP-2 expression levels?

Susan Galbraith: Thank you, Tim. So, let me just reiterate that, we’re confident in the data that we’ve seen for TROPION-Lung01. As we’ve shared already, we’ve had initial conversations with the FDA which has been encouraging, and we’re moving to file. So we’re looking forward to sharing the full data, which I think will be helpful for everybody at an upcoming conference. And that will obviously provide a more complete picture. We’re confident that the data that we’ve seen really, really enforces that Dato-DX is going to be an important potential medicine in multiple cancer types, but also including in lung cancer. In terms of the biomarker analysis, work is, as you say, ongoing. And obviously, one important source of data is going to be the TROPION-Lung01 data set. So, I look forward to updating you with data once we’ve had the chance to complete that announcement.

Pascal Soriot: The next question is from Andrew Baum at Citi.

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