Tag Archive for: ASCO 2021

An Expert’s Review of Advanced Prostate Cancer Treatment and Research

An Expert’s Review of Advanced Prostate Cancer Treatment and Research from Patient Empowerment Network on Vimeo.

What’s the latest in advanced prostate cancer treatment and research? Expert Dr. Tomasz Beer shares recent updates, and discusses how developing therapies could impact the future of prostate cancer care.

Dr. Tomasz Beer is Deputy Director at OHSU Knight Cancer Institute. Learn more here: https://www.ohsu.edu/people/tomasz-m-beer-md-facp.

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Transcript:

Katherine:

When it comes to prostate cancer research and emerging treatment options, what are you excited about specifically?

Dr. Beer:                     

Well, there is so much to talk about there. And I do want to say that the things that we’re excited about and that are promising, we want to present them in the proper light, meaning that they’re significant potential advances, but they’re not necessarily cures next year.

You know, we want to raise hopes and excitement at a proper level. So, I think right now, what we’re seeing is progress that is likely to yield drugs that will extend survival, will help us control the disease in a meaningful way. We’re not yet at a point where we can, for advanced prostate cancer, have a reasonable hope of cure in the near term. That doesn’t mean we’re not trying. We’re aiming high, absolutely.

But at the moment, the most exciting thing right in front of us, in my view, is lutetium 177-PSMA 617. That is a radioactive molecule attached to a binder that is specific to prostate-specific membrane antigen, PSMA, and essentially delivers this radioactive drug directly to prostate cancer cells by attaching to that target, the PSMA.

We recently completed and reported at ASCO and published in the New England Journal of Medicine the results of a Phase III trial, where we were able to show extension of life, extension of control of cancer, in a meaningful way, with this drug, and we’re eager to see the FDA’s review, and I think generally hopeful that the FDA will allow this drug on the market hopefully in the coming months. So, that’s a real tangible thing that is not just pie in the sky years away. I think it’s likely to be available sometime in less than a year, hopefully much less than a year. Speculating on those things is always a little risky, but –

Katherine:                  

Of course.

Dr. Beer:                     

– we all think that’s coming.

I think there are several other targeted drugs that may expand the portfolio of things that we can do in response to a mutational analysis. So, I mentioned microsatellite instability and DNA repair defects. There might be treatments for mutations in a pathway called AKT and others. And so, I think we’re going to see more very specific drugs that address segments of prostate cancer. And then a big area of activity that I’m very excited about is immunotherapy. And immunotherapy has been difficult in prostate cancer.

It has made more headway in melanoma and kidney cancer, and a number of other solid tumors, frankly, and we’re a little bit behind, and I think in part because natural prostate cancer doesn’t elicit quite as much of an immune response as some of the other tumor types; so, it’s not so easy.

But some of the newest technologies for synthetic antibodies are being designed that link the T cells from the immune system directly to prostate cancer cells and activate them, I think hold a lot of promise.

And ultimately, when it comes to cure, the immune system right now looks like the most promising strategy for actually eradicating cancer because once you activate the immune system, it can really do quite a job on cancer. Right now, for prostate cancer, that is still almost entirely in clinical trials and still for a minority of patients. So, this is not an answer for everybody, but once we get a hold of something that’s promising, I think the field’s going to work very hard to expand its utility and make it a reality for more and more patients.

 

Prostate Cancer Treatment and Research News

Prostate Cancer Treatment and Research News from Patient Empowerment Network on Vimeo.

Prostate cancer experts recently gathered at the American Society of Clinical Oncology (ASCO) annual meeting to share research updates. Expert Dr. Maha Hussain reviews clinical trial findings presented at the meeting, potential treatments for FDA approval, and credible sources for prostate cancer research information.

Dr. Maha Hussain is the Deputy Director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Learn more about this expert here.

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Transcript:

Katherine:

I’d like to start by asking about developments in prostate cancer research and treatment. Experts recently gathered at the annual American Society of Clinical Oncology meeting, also known as ASCO, to share their research.

So, what were the highlights from that meeting that you feel patients should know about?

Dr. Hussain:

I think probably perhaps I can focus on two major – what I would consider major highlights, and those were the results from two randomized Phase III clinical trials.

One of the trials is called the VISION trial. And the VISION trial was a Phase III randomized trial evaluating lutetium-PSMA-617 treatment in patients with metastatic castration-resistant prostate cancer. And the delightful thing about this study is that that study was positive. The PSMA story has been really going on for a few years now. And there’s the PSMA for purposes of scans, imaging, to assess the cancer. And the FDA just approved a PSMA PET imaging this year.

I think it was in May when it was approved. And that would help better define if the cancer is spread or not, and it help with the decision regarding treatment. But the second part is treatment purposes, so identifying the cancer location and trying to attack it with a specific sort of targeted attack to the tumor is really important.

And so, the FDA is currently looking at this particular agent. And I am hopeful that we will hear soon from the FDA, hopefully before the end of the year, and maybe – who knows? – maybe by summer, middle summer or end of summer. Because I do think that would be a major benchmark in there. And so, that’s one thing.

The other clinical trial that I thought was interesting from a data perspective – and for disclosure, I am one of the investigators on this study. And this was an intergroup Southwest Oncology, or SWOG, sponsored clinical trial. So, it’s a federal study that Dr. Aggarwal presented. And this was a study that was aiming at maximizing, again, the anti-tumor therapy with the use of a drug which I call is the younger brother of abiraterone.

So, abiraterone is a drug that is FDA-approved and has been around for several years right now for both castration-resistant prostate cancer and certainly hormone-sensitive metastatic disease. And so, TAK 700 (Orteronel) is a younger brother, I call it, of abiraterone (Zytiga). And one of the potential advantageous when this trial was designed was the fact that you don’t need to use prednisone. And the trial was completed. It was a national clinical trial. And what was interesting is that there is certainly what appears to be a potential benefit, but not in terms of the conclusive based on the way the study was designed.

Having said that, what I thought was remarkable is that patients who basically were only on the control arm was LHRH therapy, so this could’ve been like leuprorelin (Lupron), goserelin (Zoladex), or something like that plus bicalutamide, which is what we call combined androgen deprivation. And that was sort of like the strongest control arm we could do at the time when the trial was designed.

Remarkably, the patients who were on that arm had a median survival of basically 70 months. That’s the median. That’s the bell-shaped curve with the number in the middle. Seventy months is probably the longest ever in any other randomized trials in this disease space, in the hormone-sensitive space. So, that tells us is that men are living longer with prostate cancer, even though it’s metastatic disease; and, yes, it’s not necessarily curable, but men are living longer. And it’s a function of all of the better treatments that are supportive care and everything that was going on.

And so, the control arm, as I mentioned, was the 70.2 months. The actual experimental arm was about 81.1 months. And again, I don’t know where things will go from this. Obviously, I’m not the sponsor not the FDA. But the point here is that men are living longer, and so wellness and health become even more so important than we ever did. And as I tell my patients, every day you’ll live longer. The odds of living longer is there because of better treatments coming on.

So, to me – not to take too much time from the interview – to me, these were the two highlights: new, approved – I’m sorry, new treatment that I’m hoping will be FDA-approved and, obviously, the fact that men are living longer.

Katherine:

How can patients keep up to date on the research that’s going on?

Dr. Hussain:

I’m a bit biased, obviously. I’m a member of ASCO.

And what I would recommend to my patients is to look at the cancer.net website. The cancer.net is a website that is an ASCO-generated website specifically for patients and families to review. It is vetted. The committees are not run just by physicians, oncologists, a multidisciplinary team, but also patient representative. So, the lingo and the presentation are lay-friendly, I call it, there.

The other part I would say, the NCI website, and the American Cancer Society, the American Urological Association. I would say there’s a lot of stuff on the media. The difficulty is vetting what is sort of fake, what is not so accurate, or bias versus there. I also think that the NCCN has also some resources for patients.

And one thing I always tell patients: explore, look, but make sure that you talk to your doctor about the meanings of everything because sometimes it can be not – it could be misleading, I should say, or maybe not very clear on what the implications are.

Colon Cancer Treatment and Research News

Colon Cancer Treatment and Research News from Patient Empowerment Network on Vimeo.

What’s the latest colon cancer treatment and research news from the American Society of Clinical Oncology (ASCO) meeting? Dr. Smitha Krishnamurthi shares updates about research findings that were presented at the meeting along with exciting ongoing research in colon cancer.

Dr. Smitha Krishnamurthi is a gastrointestinal medical oncologist at the Cleveland Clinic. Learn more about Dr. Krishnamurthi here.

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Transcript:

How Can Prostate Cancer Patients and Providers Help Ensure Quality Care?

How Can Prostate Cancer Patients and Providers Help Ensure Quality Care? from Patient Empowerment Network on Vimeo.

How can prostate cancer patients and providers help ensure quality care? Host Dr. Nicole Rochester asks Dr. Petros Grivas to share insights about available patient resources and ways that providers can help extend improved prostate cancer diagnostics and treatments to patients for better care.

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Transcript:

Dr. Nicole Rochester: 

So, Dr. Grivas, how can we ensure that a patient’s geographic location doesn’t dictate the quality of care that they receive? 

Dr. Grivas: 

A very important question for sure, and I think as you point it out, we have touched upon this before, but I think it is definitely much more to be said and done. More importantly, I think the location has to do with multiple differences in social constructs, right? The location of the distance from a cancer center with expertise is one thing at the time to get to the cancer center is related to that, and also the social support that the patient may have, if for example, a particular treatment, for example, a clinical trial, the requires a weekly visit to the cancer center, is that the feasible thing for the patient who lives miles and miles away in the rural areas of Oklahoma or somewhere else. Can we design clinical trials that are more friendly to these scenarios that require less frequent visits. Can we provide, if possible, funding for housing closer to the cancer center, and there are examples of cancer centers doing that. They provide temporary housing for the patient to be able to be close to the cancer center, so they don’t even worry about going back and forth across the state lines sometimes. 

The other thing, of course, is insurance coverage, and again, this can have some relation to location, and it’s something we have to think about, how can we help our patients who have significant co-pays because of the recommended insurance to that location being supported by foundation or all other funds that the cancer center or the state, or again, other foundations, we have. The other issues about diagnostics and treatments, there has been some interesting discussion about particularly prostate cancer, about access to what we call next generation sequencing, which is a diagnostic test aiming to profile or fingerprint the cancer DNA to look for particular mutations that the cancer may have that may lead to a particular treatment options. 

 If, for example, mutation A is present, can we use a drug X that might be relevant in that context of a mutation and a recent data that was presented at ASCO 2021 showed that if you look at those mutations, they’re not very different between, for example, white and Black patients, there are similar types and frequencies of mutations. What is different is access to the test and, of course, access to the therapy of the test. So, I think we have to do a better job bringing ourselves to the community, extending our opportunities to the patient to get connected with the healthcare system, and they’ll build bridges to bring the patient and closer to the cancer center offering those tests. Work with patient navigation to help patients understand the significant value of the follow-up, but also provide them with a way that there’s equitable access to diagnostics and treatments. 

Diffuse Large B-Cell Lymphoma (DLBCL) Treatment and Research News

Diffuse Large B-Cell Lymphoma (DLBCL) Treatment and Research News from Patient Empowerment Network on Vimeo.

What’s the latest diffuse large B-cell lymphoma (DLBCL) treatment and research news? Dr. Jean Koff explains study findings shared at the recent American Society of Clinical Oncology (ASCO) 2021 meeting and what they could mean for the future of DBCL treatments.

Dr. Jean Koff is an Assistant Professor in the Department of Hematology and Oncology at Winship Cancer Institute at Emory University. Learn more about Dr. Koff, here.

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Transcript:

Katherine Banwell:

Cancer researchers came together recently to share findings at the annual American Society of Clinical Oncology meeting. Also known as ASCO. Are there highlights from the meeting that patients should know about?

Dr. Koff:

Well, I think at every meeting, there are lots of exciting updates to possible treatments for DLBCL. I think with the recent ASCO meeting, what a lot of researchers and clinicians are excited about are treatments in the relapse setting for DLBCL. So, there may be shifts where we are more likely to use immunotherapies known as CAR T-cells rather than what we have standardly used for patients who have relapsed after their frontline therapy.

So, that’s one of the exciting updates and we’re eager to see more details on this data. But one of the other exciting areas that we’re following closely in and ask were there several updates are a newer class of drugs, a type of immunotherapy known as fites. And these are immunotherapies that help to target the lymphoma by binding to a marker on the lymphoma tumor surface and recruiting your own immune system to attack the lymphoma. And so, we’re getting more results from clinical trials from lots of these types of agents that are showing very promising results in patients who have relapsed DLBCL.

Katherine Banwell:

What are you excited about when it comes to DLBCL research?

Dr. Koff:

So, I’m very excited about what we call precision medicine.

Which is matching a variety of treatments that we have to what is best for an individual patient. Based on the factors we talked about, like the patient level factors, but more importantly the tumor level factors. Things like gene abnormalities or even abnormalities in the patient’s immune system. We’re still in the infancy of really getting a good understanding of how these molecular factors might be matched to an ideal treatment. But that to me is really the future is matching these patients based on their tumor profiles with a treatment that is the most likely to control the lymphoma, get rid of the lymphoma and offer patients a cure.

Is the COVID Vaccine Effective for CLL Patients?

Is the COVID Vaccine Effective for CLL Patients? from Patient Empowerment Network on Vimeo.

Is the COVID vaccine effective for chronic lymphocytic leukemia (CLL) patients? Dr. Paul Barr shares insight about mRNA-based COVID-19 vaccine effectiveness in CLL patients – both for those in remission and those in active treatment.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

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An Expert’s Perspective on CLL Research Advances

Transcript:

Katherine:

I understand that researchers have been looking into whether the COVID vaccination is as effective in people with CLL. What can you tell us about that? The research?

Dr. Barr:

Sure. Everyone knew this was going to be an important question. We’ve known for a long time that riff CLL responses to vaccines in general aren’t as good as some of the normal population. So, there’ve been a whole host of studies over the years where patients didn’t quite respond as well to flu vaccines or pneumonia vaccines. Nonetheless, we typically recommend standard vaccinations, because there’s can be some degree of response. And our testing isn’t always perfect in terms of how well vaccines work.

So, when it typically, is felt to be a relatively safe procedure, is something we typically recommend.

More recently, we looked at studies on the shingles vaccine, and actually that works better than perhaps the flu shot, for example. Because patients probably were previously exposed to that virus earlier in life when they get vaccinated. So, recall response, which is a little bit easier for the immune system.

So, that brings us up to the COVID vaccines, which is obviously critically important ever on everyone’s mind. And the data’s still early. But what we’ve learned so, far is that, like what we might have predicted, our patients, the CLL patients don’t respond as well to the mRNA-based COVID vaccines.

So, in the media we saw, in the larger 20- and 40,000 patients studies that maybe, 95 percent of patients didn’t experience infection. It looks like in the general population, those vaccines work very well. In a cohort of 160, some CLL patients who are vaccinated early on in Israel, it looked like maybe about 40 percent of patients responded.

For the patients who hadn’t previously been treated but had measurable CLL, maybe about half of patients responded adequately in terms of generating antibodies. So, kind of a flip of a coin. For patients who have been treated and were in remission for more than a year, we’ll say the responses were better, maybe 80 percent or so.

For patients who are on active treatment, even our novel treatments, like the BTK inhibitors or venetoclax (Venclexta), the BCL-2 inhibitor, the responses were pretty poor, 18 or so percent.

So, you can see for patients with active disease, their responses are impaired. For those that are in remission, a little better. For those who are on active treatment, the antibody responses aren’t very good. So, I honestly think this is important information, but tell patients, don’t lose hope.

It’s still important to take the precautions. Some degree of wearing masks and social distancing. They will be better protected if their friends and family around them are vaccinated, and they still may respond to some degree. It’s not like the vaccines aren’t working at all. It’s just that the responses aren’t quite as good as the general population. So, again, another long-winded answer, but hopefully that helps patients understand some of the limitations in vaccinations.

But also that generally things are getting safer in that they still can venture out in society, but still have to take some precautions.

What Is a CLL Biomarker?

What Is a CLL Biomarker? from Patient Empowerment Network on Vimeo.

What is a chronic lymphocytic leukemia (CLL) biomarker? Dr. Paul Barr provides the definition of a biomarker and explains how they may assist in determining a CLL patient’s prognosis and treatment approach.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

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An Expert’s Perspective on CLL Research Advances

Transcript:

Katherine:

Often patients are confused with the term biomarker or biomarker testing. Would you define that for us?

Dr. Barr:

Sure. Biomarkers, I think of them as surrogates to understand the bigger picture. A lot of times what we really want to know when we’re meeting a patient is what’s going to happen in the future? What’s going to happen in five and 10 years from now? Or maybe we want to know as we’re getting closer to treatment, how well is this going to work and how long is it going to work for?

So, we do a lot of research in developing surrogate tests to try to give us an idea of what the future might hold. And so, we have developed a number of molecular genetic tests that we test for, and they give us an estimate of what to expect in terms of the patient’s prognosis.

Or perhaps they help predict for which treatment might work best. So, we often, will look at some molecular aberrations or some genetic tests that tell us about abnormalities just within the CLL cells in the leukemia cell. And they can predict for more slowly or rapidly growing disease. And other tests, might predict for, which drug might serve a patient best in terms of efficacy or how long would it work or for safety.

So, think of that as useful tools to help us give the patients an idea of what to expect over time.

An Expert’s Perspective on CLL Research Advances

An Expert’s Perspective on CLL Research Advances from Patient Empowerment Network on Vimeo

What chronic lymphocytic leukemia (CLL) research advances have emerged recently? Dr. Paul Barr shares how CLL treatments have advanced in recent years and how progress has impacted quality of life for patients.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

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CLL Treatment and Research Update: News From ASCO 2021

Transcript:

Katherine:

What are you excited about when it comes to CLL research?

Dr. Barr:

Well, it’s hard not to be excited, honestly. Five years ago, roughly, we were largely using chemotherapy.

And while patients could do very well, not all of them did. And in such a short period of time, everything has been turned on its head. We have better treatments for safer, patients are doing better, they’re living longer. There are more novel treatments being studied now. And we start to wonder if with some of the newer treatments, if maybe we actually can cure this disease. Maybe if the majority of them, they might be able to live a normal lifespan. So, we’re incredibly optimistic.

Those are very general statements, but they really are, they come from just the impressive outcomes that we’ve seen from patients being able to be at home, take their treatment, go into deeper remissions and do better in the long-term.

So, yeah, there’s a lot to be excited about. And that’s why my answer is just kind of general. There’s a lot to focus on, from the different novel agents to MRD-guided therapy, to some of the CAR-T products that are coming out. I really think it’ll continue to change at a pretty rapid pace.

Katherine:

That sounds very promising. When it comes to new developments in research, how can patients discuss this type of information with their doctor to find out if there’s a new approach or a clinical trial that might be right for them?

Dr. Barr:

Well, I honestly think they should feel empowered to simply ask. I know a lot of my patients they will want to know anything new. They can ask us, generally is that, they know that we have these major meetings twice a year. And what’s new with these treatments. Or many of them are on clinical trials and want to know, “Do we have any results yet? What’s been changing?” And sometimes at the end of every visit, we’ll spend five minutes just talking about the new developments or what’s coming down the pike or how practice is changing.

I’m just in the routine of having this conversation with most of the patients on a recurring basis. And honestly, they feel well-served, like we’re keeping them up to date. I think patients enjoy that sort of conversation. So, I wouldn’t feel shy about simply asking.

How Can You Engage in Your CLL Care?

How Can You Engage in Your CLL Care? from Patient Empowerment Network on Vimeo.

How can chronic lymphocytic leukemia (CLL) patients become more engaged in their care? Dr. Paul Barr explains steps that patients can take to activate shared decision-making with their provider for optimal care.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

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An Expert’s Perspective on CLL Research Advances

Transcript:

Katherine:

We’ve been hearing a lot about shared decision-making lately. In your opinion, how is this concept best put into practice?

Dr. Barr:

So, I honestly think shared decision-making is not just useless term. This is something we actually really use in our clinics, and it’s very important for the care of CLL patients, where we have patients who do very well for a long period of time. And there are a lot of different management decisions and a variety of treatment options that we have to discuss.

So, when we have that luxury, it’s really important to help educate patients on the different options and to better understand what their goals of care are, so they can help us decide what’s best for them. When we’re deciding just, one example is that, when we’re deciding on various treatments, we can use agents that are given orally, taken at home, but patients may be on them for many years.

Alternatively, we have fixed duration regimens, but may involve trips to the infusion center. And a lot of these different treatments all work very well. So, involving the patient in that decision making process, makes the process that much easier for the patient and enables you just to take better care of them over the long run.

Katherine:

What is the role of the patient to making treatment decisions?

Dr. Barr:

Well, I think that the role of the patient is really to be their own advocate. Take all the information and then, help us make decisions together. And to just be very honest about what they want from, not just a simple decision about a treatment, but from their overall care. To really just to be as involved as possible and to make sure all of their concerns are heard, all of their questions are answered.

Katherine:

For those who might have trouble speaking up for themselves, what advice do you have for them?

Dr. Barr:

Oh, I would say, especially for our patients with CLL, often there are many,

many appointments along the way, where there may not be urgent decisions being made and there are opportunities to slowly learn more to ask questions. So, as much as possible, try not to be intimidated by that visit to the cancer center, which obviously can be anxiety provoking, but to develop a relationship with your hematologist, your oncologist, your care team so, that they can take better care of you.

I honestly think it works best when you slowly get to know your team, understand the field, some of the decisions that need to be made and that the team only wants what’s best for you. So, yeah, I honestly think it’s – think of it as a process. It’s not a one-time visit where you have to get everything out and get everything answered. It should be a relationship.

CLL Treatment and Research Update: News from ASCO 2021

CLL Treatment and Research Update: News from ASCO 2021 from Patient Empowerment Network on Vimeo

What’s the latest chronic lymphocytic leukemia (CLL) treatment and research news out of the American Society of Clinical Oncology (ASCO) 2021 meeting? Dr. Paul Barr shares study results and explains how they could impact CLL care.

Dr. Paul Barr is Professor of Hematology/Oncology at University of Rochester Medical Center. Learn more about Dr. Barr, here.

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An Expert’s Perspective on CLL Research Advances

Transcript:

Katherine:

I’m Katherine Banwell, your host for today’s program. Joining me is Dr. Paul Barr. Dr. Barr, would you please introduce yourself?

Dr. Barr:

Sure. Hi, Paul Barr from the University of Rochester. Glad to be here.

Katherine:

Thank you so, much. Cancer researchers came together recently to share findings at the annual American Society of Clinical Oncology meeting, also known as ASCO. Is there news from the meeting that CLL patients should know about?

Dr. Barr:

There is. It seems like at every major meeting, we have a potentially practice-changing dataset that we like to scrutinize and talk about. This ASCO is no exception. I think probably the most impactful abstract was a report.

The first time we’ve seen the results from a study that was called The ELEVATE Relapsed Refractory Study. This was a randomized trial, enrolling previously treated CLL patients who had high-risk disease and randomizing them to two of our very important BTK inhibitor treatments.

Half the patients got acalabrutinib (Calquence), and the other half received ibrutinib (Imbruvica). And both groups were treated until the drug essentially either stopped working, the disease became resistant or was stopped for side effects. So, this was a study we have waited on the results for a long time given that we don’t often see these randomized studies comparing two such active agents. And the results showed us that both drugs work really almost equally as well.

The progression-free survival or the roughly the average amount of time patients are taking the drug was just over three years, 38 months in both arms. So, they really work very well and equally as well. But we did see less side effects with the acalabrutinib. And one of the most important side effects that the study was powered around was, atrial fibrillation or flutter.

There was less AFib or less new AFib in patients that were treated with the acalabrutinib. There was also less minor bleeding, arthralgia, diarrhea. So, a number of, perhaps less severe type side effects, were less common. There was more headache and more cough in the acalabrutinib-treated patients. But I think overall, most of us took from this abstract that both drugs work exceptionally well.

And overall, are very well tolerated treatments although there does look to be lower rates of a number of important side effects with acalabrutinib.

Katherine:

Dr. Barr, is there any other news from the conference that patients should know about?

Dr. Barr:

There is. I’ll give you a couple other additional findings. One was an update of a study, we’ve seen the results before. It’s sort of a partner study to the one I just mentioned. It was called The ELEVATE TN or ELEVATE Treatment Naive Study.

These were previously untreated patients, treated with an old standard, randomized study where the patients received either chlorambucil-based therapy (Leukeran). It was combined with a CD20 antibody obinutuzumab (Gazyva). The second arm was single agent acalabrutinib and the third arm was acalabrutinib plus obinutuzumab. Not surprisingly both of the acalabrutinibs continue to perform very well. The treatments work much better than chlorambucil. But now, we have four-year data. And that’s important for us to really understand what to expect as time goes on.

And I think that the major take-homes are that, acalabrutinib continues to work very well in the first-line setting. There is a hint that acalabrutinib, I’m sorry, that obinutuzumub may prolong the remissions, which is a little bit surprising to us.

But again, small differences in the study weren’t powered to really look at that comparison. And also, the major take home from that dataset is that the safety still looks very good at four years for the patients receiving acalabrutinib. So, I think that continues to shape our practice. And I think the last dataset or abstract to comment on, was one actually we saw at a different meeting at the European Hematology Association meeting, EHA. And this was another randomized study comparing two different BTK inhibitors in relapsed CLL patients.

This one compared ibrutinib and zanubrutinib (Brukinsa). Like acalabrutinib, zanubrutinib is another more specific BTK inhibitor. And when you compare it to ibrutinib and perhaps somewhat similarly to The ELEVATE Relapsed Refractory Study in this zanubrutinib-ibrutinib comparison, so-called ALPINE study, we saw similar efficacy.

Zanubrutinib actually looked like it performed a little better than ibrutinib, but also again here, lower rates of side effects. So, the theme continues for the more specific BTK inhibitors. They seem to work just as well, maybe a little better in some respects, compared to Ibrutinib and somewhat lower rates of side effects. So, when you put it all together, all of the BTK inhibitors work exceptionally well.

We have varying degrees of follow-up and confidence. We have the most follow-up in our ibrutinib treated patients so, we know what to expect for patients six, seven years out after being on ibrutinib.

But we’re now seeing in these earlier studies that lower rates of various toxicities for the newer more specific BTK inhibitors. So, kind of a long-winded answer to your simple question, but hopefully that shows how the new and emerging data continues to shape how we take care of patients.