Dr. Shubh Goel on Niagara Trial Results and AstraZeneca’s Global Impact

Amalya Sargsyan: Hello, everyone, and welcome to OncoDaily. I’m Amalya Sargsyan, and today I’ll be your host. Today, we have our honor of welcoming vice president and head of immuno-oncology and GI tumors franchise of U.S. oncology business unit of AstraZeneca, Asif Gavil. Thank you for joining us and accepting our offer. It’s our pleasure to have you today with us.

Shubh Goel:  Thank you so much for having me. I’m excited to be here.

Amalya Sargsyan: So today we are going to explore some recent breakthroughs and advances in oncology, as well as think about future and what the future holds for us. And do you mind telling us a little bit more about you, your role in AstraZeneca and your background?

Shubh Goel: Yes, I’m happy to. So I joined AstraZeneca just over two and a half years ago. I have been in the oncology space for more than 20 years.

I started my career as a biochemist in the science side and then moved over to the commercial side of the business because I was really driven by bringing patients new therapies and really seeing the difference that they could make. Super excited to be at AstraZeneca and really kind of be a part of our growing portfolio where I really think we’re bringing meaningful differences to patients across the realm of targets and agents that we have. Immuno-oncology being one of those areas.

Amalya Sargsyan: Yes. Thank you for sharing what inspires you to do your work and thanks for the great job you are doing already. And less than a month ago, AstraZeneca announced the results of the Niagara trial.

It was a phase three trial where Durvaluma with chemotherapy demonstrated improved results with the fund for survival, overall survival in muscle-invasive bladder cancer, right? So can you tell us a little bit more about this trial? Design, which countries were involved?

Where did you start? And a little bit more details on it.

Shubh Goel: Yes, of course. So the study was a global study across multiple centers. I actually don’t have at hand all of the countries that were involved, but there were a number of countries around the globe that were involved.

It was a phase three study, as you mentioned. We are excited to see the positive high-level results that we press released recently, and that is of infimsy in combination with chemotherapy, both in the preoperative and then postoperative setting. So what we call perioperative setting.

And what was really exciting about the study is we actually saw that we achieved clinically meaningful improvement and statistically significant improvement in the primary endpoint of EFS, which is event-free survival, and also the key secondary endpoint of overall survival. And that was versus neoadjuvant chemotherapy alone. So, you know, I think you might be aware that patients usually will receive a cystectomy or bladder removal during this process.

So we’re really looking at the addition of IO before and after that process. So then again, oh, sorry.

Amalya Sargsyan: You can go ahead, please.

Shubh Goel: No, I think, you know, last thing I think that answered your question is this is the first immunotherapy regimen to read out this kind of event-free survival and overall survival benefit in this bladder cancer space. So why we’re super excited about it.

Amalya Sargsyan: Yes, it’s very encouraging to hear about it. So this makes Druvalubum the first one to be before surgery and after surgery. And also, as you have mentioned, besides overall survival data is also important, the quality of life of patients.

And if we can preserve from these surgeries, it will be a major success. And so coming back to the results you have shared already, very promising efficacy data. Can you share with us a little bit more about safety data, too?

What were toxicities? Were they manageable? What were major side effects that you are seeing with this trial?

Shubh Goel: Yes, at a high level, we know that infirmity was generally well tolerated and the safety concerns were consistent with, you know, what you would expect to see in a neoadjuvant or adjuvant setting. There will be more detailed safety reading out when we present the data at an upcoming conference, which, you know, we’re eager to see this at ESMO in the future.

Amalya Sargsyan: Oh, so we’ll keep our fingers crossed for the results in ESMO. And I think this interests a lot of listeners. Why it is called Niagara?

What is the story behind it?

We’re also looking forward in the future to see a readout from Potomac, which is an earlier setting of non-muscle invasive bladder cancer. And then we’re also looking for a readout of the Nile study, which is in more advanced stages of bladder cancer. And so you can see we have a bit of a river theme.

I can’t tell you where the river theme came from, but it does sort of combine our bladder cancer approach.

So you thought that a small will be the first one we will see the results. And when do you see the end of the trial and when to expect the final ones?

I think what’s really exciting, though, here is that we’re actually already seeing a clinically meaningful benefit in overall survival, which is usually what we’re waiting for as we’re continuing to wait for readouts of studies. So, you know, I think at this at this early stage, seeing those two endpoints read out is really exciting to see.

And let’s a little bit go beyond this trial. Your role in AstraZeneca is working not only with this one. And can you share us about some studies that you are most excited for and you are waiting for results in AstraZeneca and which do you think that could be practice changing?

And so we look at that across the board, including the advanced setting. And as you already know, we had recently had approvals in the cholangiocarcinoma and BTC space, which has been a need area. And I’m looking forward in that vein to also see continued readouts and potentially in the future approvals for studies like Adriatic, which was the first study to read out a benefit in the limited stage small cell lung cancer space.

So, again, really high medical need with more than four decades of lacking in advancements for those patients. So that’s one area that I think we really are excited about. I think the other area is moving earlier into the disease state, because we really believe that the earlier you can intervene for a patient, the more likely we are to have a benefit on longer term outcomes.

And so just like Niagara, we have a number of perioperative studies across across some indications, including the Aegean study and respectable non small cell lung cancer, which has read out. We’re hoping to bring that to patients in the near future. And as also the Matterhorn study, which is in the gastric and gastroesophageal junction space, again, very similar to Niagara, where we are incorporating emphysema with chemotherapy ahead of surgery and then after surgery.

And we’ve seen the initial readouts of that study with PCR results. We are waiting on that study to read out EFS and OS. So more to come on that study.

But an area of real kind of focus for us in terms of moving earlier. Continuing on that moving earlier kind of thread, we also are now looking at a number of adjuvant studies as well. And so I already mentioned earlier disease studies.

So I already mentioned the Potomac study in bladder cancer as well. We also have an Emerald two, which is an adjuvant study design in HCC or liver cancer, hepatobiliary cancer, sorry, hepatocellular cancer. My my apologies.

And we also have, you know, within that earlier space, Emerald one and Emerald three, which are looking at intermediate patients as well. So slightly earlier than our current indicated space of Himalaya in the hepatocellular carcinoma space. So I think, you know, when you look at our pillars, we’re looking at high medical need where we can really make a benefit.

And then we’re looking to move earlier in disease to really try to affect outcomes earlier and really improve those longer term survival opportunities.

Is this right? Yeah, indeed. This ASCO was full of results and hopefully we’ll see some more updates at ESMO and keep updated and hopefully we’ll have follow up calls and follow up updates on the trials as well.

And just as we are moving through what is done and what is waiting, if you already know, Oncodeli had an article about 10 most promising cancer drugs, which are not yet approved in solid tumors in 24. And for our listeners who are not familiar with this article, we’ll put the link in our description. And what is a huge success, I think, for our company too, is that from 10 to where from AstraZeneca.

And it was that the bottom of their Instagram and our editorial team believe that these drugs are going to be approved soon. And hopefully we’ll have the list which moved these drugs from not approved to approved one. We saw the potential there.

Congratulations on being on this list. And just to share your ideas about it, can you share a little bit more about these drugs and just in general? And when do you expect them to be moved from the approved list?

And if you have on your pipeline more drugs that you think have the greatest potential that to be approved, what would you suggest for our 2025 edition?

And thank you for having us on the list and sort of recognizing the portfolio. I think AstraZeneca, you know, look, we have a bold ambition to eliminate cancer as a course of death. And I think what I when I look at our portfolio, you know, we have we have products like the ones you mentioned that are slightly closer to approval.

And then we have products that are further away that, again, could bring us the next wave in the future. And I think that’s what I’m most excited about. When we think about our portfolio, we think about it in terms of really being able to combine mechanisms across multiple different modalities so that we can continue to improve outcomes, you know, potentially improve those longer term survival benefits, especially if we’re able to move earlier and improve the quality of that cancer care, if we can start to eliminate chemotherapy.

And so that’s our overall goal. If you look at our portfolio, sort of looking into the future, we have, you know, really committed to a couple of areas in a big way, including ADCs like Dato, as well as more a follow on immunotherapies. And I think, you know, for me, I look at that and look at sort of the wave of the by specifics that are coming in the future.

And, you know, we really have an opportunity, hopefully, to continue to improve outcomes. But now with one compound or regimen versus a combination or a cocktail, be able to potentially combine within our own portfolio and eliminate chemotherapy and really start to affect those longer term outcomes in a bigger way. So, you know, what I will say to your question is we’re committed for the long haul.

We’d like nothing more than to be put out of business by eliminating cancer. And I think we have a portfolio ahead of us that can really help us do that with a multitude of different agents and targets that we can combine.

And you have mentioned that combining therapies and acting could be another key of success to finding the best way to go forward. And hopefully we’ll see another drug seen over 2025 list. Let’s keep our fingers crossed and just on a different road.

In the past decades, immunotherapy had a major role in impacting the cancer care and continuing to do so. But within all of these breakthroughs, it is not usually accessible to a lot of population. So how do you see this on the global perspective for low middle income countries, expanded access or maybe expanding clinical trials across the globe?

So how do you think making it more accessible?

And I will say that one of the areas that we really do focus on is within the United States, thinking about, you know, starting with health equity in terms of access to clinical trials, right as the clinical trials are being put into place. And we’re continuing to work on that all the way through to making sure that patients have access and various appropriate mechanisms that we can. And so more work to do.

We continue to work on it, but definitely an area of commitment for AstraZeneca.

So what keeps you going in this field? It is a drug development, a lot of failure, a lot of drugs are not going to go through, but you are committed and doing what makes you believe in the drugs and do what you are doing. So what is your secret?

That’s really amazing. And I think that’s what really motivates me. Then I look at our portfolio, as we just discussed, and we have a number of those readouts across multiple different tumor areas.

And every time it makes us so proud to be able to bring that difference to patients. And that’s what really keeps me going. I’m excited for what we have today in our portfolio and what we’re able to bring to patients.

I remain motivated by all the readouts we have that allow us to bring more of this regimen to more patients in different tumor areas where there hasn’t been something before. And then as we look forward to our portfolio, I really do think that we have the opportunity to continue to really make a difference across multiple different cancer areas. And I feel very passionate about doing that.

It’s incredible. And thank you for accepting our invitation and being today with us. It was very interesting.

And hopefully we’ll see more results coming from other trials and we’ll follow up on that. And thank you for being us. If you have anything to conclude, we are happy to hear that.

But thank you so much for the time today.