ASH Review: MedScape on R/R FL

I'm still sifting through some of the commentaries that people are posting about what they saw and learned about Follicular Lymphoma at the ASH meeting. Today's commentary is a video, posted by the website MedScape, called "Charting New Horizons: Emerging Data and Novel Therapies in Relapsed/Refractory Follicular Lymphoma."

I guess it's technically a video, since it's posted on YouTube. But really, it's more like a podcast -- audio commentary without any real visual element. There is the option of seeing a transcript. You'll find a button in the description box below the video.

The post features two Lymphoma experts, Dr. Lori Sen from the University of British Columbia, and Dr. Cammy Maddox from Ohio State University. Their focus is on presentations from ASH that present data from studies on Relapsed and Refractory Follicular Lymphoma.

Of course, the first one they describe is the one that everyone is talking about: Tafasitamab and R-Squared. I've seen it called a "triumph" and a "practice-changer." Dr. Sen and Dr. Maddox seem equally impressed. They point out that the study was very wide, taking place in multiple countries. It was double-blind, meaning there was a direct comparison between two treatments. It had excellent results and good safety. And it showed that it is possible to combine two monoclonal antibodies -- one that targets CD 19 and one that targets CD20 -- and have good effectiveness and safety. I have to say, the more I read about it, the more impressed I am. I'm still not sure it will be the "game-changer" that some seem to think it will be. But that's  more about asking oncologists to break old habits than anything about how good the treatment is. 

The next presentation they describe is "337 Loncastuximab Tesirine with Rituximab Induces Robust and Durable Complete Metabolic Responses in High-Risk Relapsed/Refractory Follicular Lymphoma." Loncastuximab is an antibody conjugate. Basically, it's like Rituxan, targeting a protein on the surface of the lymphoma cell (CD19), but attached to it is a small drop of a chemotherapy drug. This allows the chemo to go directly to the cancer cell. In theory, this results in fewer side effects and better effectiveness. The Overall Response Rate was  97.1% after 12 weeks, with a Complete Response of 68.6%. For the FL patients in the study, the ORR was 100% and the Cr was 80%. Safety was good. A wider study is ongoing, so we may hear more about this one soon. 

The next presentation they look at is Epcoritimab with R-Squared, another one that has gotten lots of commentary since the meeting ended. I was curious about what they had to say about the possible safety issues with this treatment combination. They do mention that the study happened during the Covid pandemic, which likely affected things negatively (since the combination would affect immunity). There were no new side effects -- nothing unexpected. 

They finish by talking about how the data will affect clinical practice. Again, Tafasitamab and R-Squared have a prominent place here. In general, they seem to agree that the various presentations at ASH that excited them most are more proof that we are moving away from traditional chemotherapy and towards treatments that involve the immune system and that target lymphoma cells specifically. This has certainly been the trend for a while, and it's a good thing. They also agree that using these newer treatments effectively takes some learning on the part of oncologists. They will require active surveillance of side effects so things like Cytokine Release Syndrome don't become too dangerous.

It's an interesting video/audio, and it reaffirms a lot of what I've been reading and hearing so far.

Still a few more commentaries to sift through. If there's something good in them, I'll be sure to share.

ASH Review: 5 Year Follow-Up for CAR-T

Continuing our look at what Lymphoma experts have to say about presentations at ASH a couple of weeks ago. I'm seeing lots and lots of commentary about Tafasitamab + R-Squared (the excitement was there even before the ASH meeting began, so no surprise there).

One commetary caught my eye this morning. It's from the lead researcher for abstract #864, "5-Year Follow-up Analysis from ZUMA-5: A Phase 2 Trial of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma." 

The commentary is from an article website Health Day, and features a video (with written transcript) from a Leukemia specialist and a Lymphoma specialist.  The Lymphoma specialist is Dr. Sattva Neelapu from MD Anderson, who discusses the abstract above.

The presentation looks at data from the ZUMA-5 trial. There are a series of ZUMA trials, each looking at the CAR-T known as Axi-cel or Yescarta, but looking at the effects from different patient populations. ZUMA-5 focuses on patients with indolent NHL, including Follicular Lymphoma, who had relapsed or refractory disease. The ZUMA-5 trial actually resulted in Axi-cel being approved for R/R FL in 2021, so this research isn't about trying to show the FDA that it is safe and effective. We already knew that.

Instead, this presentation is meant to show that Axi-cel remains safe and effective. 

The study involved 159 patients, with 127 of them having been diagnosed with Follicular Lymphoma. The patients in the study had already received at least two other treatments, including immuno-chemotherapy (like R-CHOP or B-R). This presentation looks at what happened to the patients after 5 years. 

In the video, Dr. Neelapu says the Overall Response Rate was 90% and the Complete Response Rate was 75% -- even higher in patients with Follicular Lymphoma at 79%.

The median Duration of Response -- how long it kept the cancer away -- was a median of 60.4 months, or a little over 5 years. (Median means half had a longer response and half had a shorter response).

Among patients who achieved a CR, 58% remained in response after 5 years. The Progression Free Survival rate was similar at 50.4%. For patients with a Partial Response, the PFS was 6.9 months. The median Overall Survival was not reached. To get a median, you need half of the patients to have died, so after 5 years, more than half were still alive -- the researchers estimated 69% of the patients were still alive after 5 years.

Among patients with Follicualr Lymphoma, the OS was estimated at about 65%, meaning 35% of the patients had died, whether from disease progression or from some other cause. These other causes included some secondary cancers and infections, as well as non-cancer-related causes.

I their conclusion to the abstract, and in the video, the researchers say that the results show that Axi-cel may have the potential to be a cure for a certain subset of patients.

I have a couple of thoughts.

First, looking at the numbers, it's clear that CAR-T is improving. The early results from CAR-T showed that roughly 33% of patients had a long duration of response, 33% had a duration of about a year, and 33% did not respond at all. The numbers here after 5 years are a lot better. CAR-T is working, and after some time, oncologists are getting better at dealing with side effects and with identifying who will be helped by CAR-T. 

Second, that word "cure." It's a funny word when it comes to Follicular Lymphoma. Clearly, CAR-T was not a cure for a whole lot of patients in the study. But clearly, it has been a huge help to a whole lot of others. The problem with using that word is that "cure" is hard to measure. In other cancers, the 5 year mark is often used to declare someone as "cured." But FL has a habit of coming back even after 5 years, at least for some people. 

But many oncologists use the term "functional cure." If an FL patient is diagnosed at a later age and has a treatment that lasts for as long as they live, we can call that "cured." And for others, the disease may return, but in a less-aggressive way that doesn't require treatment. That makes them "cured," in a sense.

Many FL patients use the phrase "Dying with the disease, not from the disease." And that amounts to a "cure" in a way, too.

I have my own issues with the word "cure," obviously, and I may write more about that sometime soon. But for now, we at least agree that for many patients, Axi-cel CAR-T has been very successful.

I'm still sifting through some other post-ASH commentaries. I'll share more soon.

ASH Review: Epcoritimab + R-Squared

 OK, SH is over, and it's time to continue to look at some of the presentations that made some noise. We already looked at some of the FL presentations that got some attention (those presentations on diet and blood cancer had some people talking on Twitter/X). 

So now it's time to look at the presentations that are getting attention after the meeting is over. 

Let me first respond to a comment from a reader named Peter, who wrote about my post on the "triumph" of Tasafitamab. He wrote "I’m always a bit skeptical of headlines that use superlatives (like “triumph”), especially when they’re from less scientifically rigorous sources (like fiercepharma)....A good mantra I learned to repeat to myself, back when I was first getting diagnosed and learning about lymphoma, is “if something sounds too good to be true, it probably is”. I found it the best way to try to control my own confirmation bias."

Amen to that. And it is with Peter's words echoing that I present to you "342 Fixed-Duration Epcoritamab + R² Drives Deep and Durable Responses in Patients with Relapsed or Refractory Follicular Lymphoma: 2-Year Follow-up from Arm 2 of the Epcore NHL-2 Trial." 

This presentation looks at data from a phase 1b/2 clinical trial. (This means they have combined the phase 1 study, which focuses on safety, and the phase 2 study, which focuses on effectiveness -- they use many of the same patients rather than having to start a whole new trial). There were 111 patients in the trial, and they received the bispecific antibody Epcoritamab as well as the combination R-Squared (Rituxan + Revlimid, also known as Ledalidomide). The patients all had relapsed or refractory disease (their last treatment didn't work or had stopped working). 

The results were very good -- the patients had an Overall Response Rate of 96%, and a Complete Response Rate of 87%. That's pretty great. The treatment worked well no matter what the patients' treatment history was. Patients with POD24 had a CRR of 79%, for example. After a median follow up of 24 months, an estimated 69% of patients were still responding to the treatment, and 75% of those with a Complete Response had maintained their Complete Response.

The researchers note that the study took place during the Covid pandemic, and 57% of patients reported getting Covid at some point, resulting in a number of health problems, though there were no Covid-related decisions to stop Epcoritamab.  The most common side effects were were neutropenia (62%) and Cytokine Release Syndrome (51%). At a median of 25.3 months, 17 patients (15%) were still on the treatment; 41 patients (37%) had completed treatment as it was described in the study description; and 53 (48%) had stopped treatment for several reasons: 18 of them had their disease progress, 22 had severe side effects, 7 withdrew from the study on their own, 1 died, one left because of Covid, and 4 left becuase of a doctor's decision.

So why the "If it's too good to be true, it probably is" attitude? 

A lot of the post-meeting analysis will come in the next few weeks or months, at least from oncologists and oncology-focused web sites. The more immediate analysis come from other web sites, and that's where almost all of the news that I got about this presentation came from, namely, finance and investment web sites.

In other words, at least immediately after the ASH meeting, the folks who are most excited about this are the ones who will make some money off of it. 

I've struggled with this for years, and in the United States, we're in the middle of a very controversial situation that is related to it. I won't get into that, because I don't think I can describe my feelings about it very well. 

But I also have to have a little skepticism about the excitement that a new treatment regiment is generating based mostly on a press release from the company that has developed it. It might very well be one of the ASH presentations that oncologists are excited about, and that they'll discuss elsewhere. But I'm going to hold off on my excitement until then, especially given that almost half of the trial participants dropped out before they finished. In their abstract conclusion, the researchers point out that there are no new side effects, compared to the Epcoritamab trial that resulted in its being approved for FL by the FDA and the EU. (And despite there being some safety concerns about Epcoritamab, too.) A few people are talking about it online, but no one is really bursting with excitement.

The clinical trial had a few arms, so there were patients who received Epcoritamab and B-R, for example. It will be interesting to see what oncologists have to say about all of it in the next few weeks and months. I'll keep you posted.

In the meantime, be the good critical thinkers that you are. Stay hopeful, but realistic.

ASH Preview: Practice Changers?

The ASH conference is in full swing today, so I won't be calling my ASH posts "previews" after this. But I'll do it once more in looking at an article from Oncology News Central that was published earlier this week. 

It's really easy to get excited about a conference presentation, and even easier to get excited about an abstract. the presentation itself might last an hour, and involve more detail and some audience questions. the abstract is just the summary -- the good stuff. As Dr. Leonard points out in his Leonard List podcast, that can leave out a lot of the complications that can make it a little less exciting.

And then there's the place that a conference presentation has in the whole life cycle of a research project. The best look at research comes from a publication in a medical journal. That's where it will be peer-reviewed -- other experts in the subject will look it over and point out problems and ask for changes, and if it looks good after that, it will be published. A conference presentation doesn't go through all of that review.

My point is, remember that my ASH previews, that look at abstracts, are only the first step in a long process. The things I look at here -- and that I get excited about -- won't necessarily make their way to the doctor's office any time soon, if they do at all.

Which is why the article from Oncology News Central is so interesting. 

It asks the question, "What Blood Cancer Advances Could Change Practice?" In other words, which presentations at ASH really will end up in the doctor's office some day? They asked some blood cancer experts which abstracts could be important enough to change the way blood cancer patients are treated in the future.

Follicularr Lymphoma makes an appearance. they asked Dr. Cunthia Dunbar from the National Institues of Health, who also serves as Secretary of ASH. One of her picks is "LBA-1 Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Results from a Phase 3 Study (inMIND)." It's the late-breaking abstract that I wrote about a couple of weeks ago, looking at Tafasitamab added to R Squared. As I said then, "I'm guessing this is going to be the Big Story about Follicular Lymphoma when the ASH conference is over, and we'll be hearing more excitement about it from the experts who give their opinions about things." So we're getting some of the excitement a little early.

Dr. Dunbar says “Tumor cells can evolve to escape targeted therapies via loss of a single target molecule, such as CD20. This approach of using two antibodies simultaneously aims to prevent this escape, resulting in better outcomes.”

That's the only abstract that deals directly with FL to make the list in this article. But there are a few others that get at Quality of Life issues that are worth looking at. The article has a section called "Diet and Lifestyle Focus “Bold and Different” From Previous ASH Meetings." A couple of abstracts look at the influence of higher fiber intake after Stem Cell Transplant, with the idea that they may improve gut bacteria in positive ways. Another looks at a ketogenic diet–derived metabolite that might have the potential to help CAR T be more effective.

I know there's a lot of interest among many FL patients for things like dietary changes that could help us. To be very clear, all of these studies are in very early stages. They are discussed in the article by Dr. Mikkael Sekeres of the University of Miami (a Lymphoma Rock Star, to be sure). But he cautions, "We need to wait for clinical trials before we recommend more restrictive diets whole hog."

You'll notice I have not linked to those studies directly. You can find links in the Oncology News Central article if you want to take a look.  But I'm going to make you work for it. Consider it symbolic -- we often look for quick answers when it comes to things like lifestyle changes to help our cancer.  But they're never that quick and easy. So if you want to read more about them, you'll need to work for it. 

And keep in mind that these abstracts aren't saying that a high fiber or keto diet will cure your cancer. They're looking at how dietary choices may influence how well a specific treatment works. that's a very different thing.

Still, I look forward to seeing the reactions to ASH. I'll share them as they come about over the next few days and weeks.

 

ASH Preview: The Leonard List 2024

I'm doing another ASH post, this time looking at several ASH presentations at once. I'll look at them through the lens of the Leonard List.

The Leonard List comes from Dr. John Leonard of Weill Cornell Medicine. Dr. Leonard is one of the best-known Lymphoma specialists in the U.S., and every year he publishes his List of the 10 most interesting abstracts from ASH, about a week or so before the meeting happens. He discusses them, plus a few bonus ones, on the "CancerCast" podcast from Weill Cornell. You can listen to the full podcast episode here; there's also a transcript if you want to read along or translate it more easily.

I always enjoy listening to Dr. Leonard go through his list, especially when I have already written about something that he finds interesting. I will only focus on his choices that are related to Follicular Lymphoma, but if you are interested in other types of blood cancer, I encourage you to listen to or read the whole podcast for some other great commentary.

The first time FL makes the lost is at number 7, and it actually shows up twice -- Dr. Leonard lists two related abstracts as 7A and 7B on his list.

7A is  "3749 Subsequent Primary Malignancies in Patients with Indolent B Cell Non-Hodgkin Lymphoma Receiving Frontline Bendamustine Rituximab Therapy.” In this presentation, the researchers look at the records of 6284 patients with slow-growing lymphoma (inlcuding FL, but some others, too) who received Bendamustine as their first treatment. They were interested in how many patients went on to develop another cancer after the treatment. According to their research, about 15% of them developed a second cancer, with a median time to diagnosis of 2.36 years, including lung cancer, digestive system cancer, and other blood cancers. Did the Bendamustine cause the other cancers? It's hard to say, as Dr. Leonard says, since many of the patients went on to other treatments, including radiation and Stem Cell Transplants, or simply have immune systems that make them susceptible to other cancers. The takeaway, says Dr. Leonard, is not that Bendamustine is bad or that one treatment is better than another. "To me, the takeaway here is that patients need to be monitored for other cancer. And I think that that is a really important issue for all lymphoma patients. You have to think about lung cancers and GI cancers and monitor for blood cancers, breast cancer, et cetera. And so to me, the takeaway actionable item here is really just to make sure that patients are followed and get the appropriate cancer-related screenings because they are at risk for other cancers." That's an important distinction. We're all at higher risk for other cancers; the scar on my scalp is a reminder of that. Be sure to keep up with cancer screenings.

7B is related: "3009 Impact of Prior Bendamustine Exposure on Bispecific Antibody Treatment Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma." This one looks at FL patients, specifically, who have had Bendamustine, and the went to receive a bispecific antibody. Since Bendamustine can affect T cells, and bispecifics work by engaging T cells to go after the cancer cells, the researchers wanted to know if receiving Benda would make the bispecifics less effective. This is tough, as Dr. Leonard points out, becuase there can be lots of reasons why a treatment doesn't work, and like 7A on the list, lots of patients in this study received other treatments besides Benda. No matter -- the patients in the study didn't seem worse off than other patients receiving Benda when they went on to receive a bispecific. By the time most patients receive a bispecific after Benda, it's been at least a year, and their T cells have had time to recover. It's one less thing to worry about if you've had Bendamustine.

Next on the list is number 2, which isn't directly about Follicular Lymphoma, but it's really interesting to me. It's "2267 Toxicity Outcomes in Phase 1 Lymphoma Trials: Variable Reporting with High Use of Minimizing Language in Published Abstracts at International Conferences." I'm especially interested in this because I have a real interest in the language we use to talk about cancer, but also because this research affects the way I write the blog. The researchers looked at presentations from major cancer conferences (like ASH) that reported results from phase 1 clinical trials. They were interested in how safety was discussed in these presentations. There's kind of a tension here. On the one hand, phase 1 trials are all about safety; the whole idea is to figure out what dose of a new treatment will work well but do the least harm. On the other hand, someone presenting data about a new treatment wants to make it sound as good as they can, so there's a temptation to be more positive than they should be. As the research points out, you'll se a lot of language like "tolerable" or "safe" or "manageable" when talking about side effects, but there's no accepted definition for what those words mean. So it's important to look carefully at the numbers and not just rely on the language being used.

(This hits home for me, as someone who writes about clinical trials all the time. I have to force myself sometimes to bring up the potential safety issues. Just a couple of days ago, my wife was reading my last post, in which I mention that several patients died during the study. She really doesn't like to read about that. I pointed out that, first, a number of those patients died because the study happened during the Covid pandemic and had weak immune systems, something I didn't mention in the blog post, and second, it's important information and needs to be mentioned. I remember a few years ago someone talked about me on a Facebook group, and someone else said I could be too negative sometimes in my writing. It's true, I can be negative but I try hard to be just the right amount of negative, not too negative. I don't see much point in not giving you the potential bad with the good. False hope isn't good for anyone. Every treatment comes with some trade off,and we need to remember that.)

Number 1 on the Leonard List is about Follicular Lymphoma: "1652 Outcomes in Early Relapse of Follicular Lymphoma Versus Early Histologic Transformation Following Firstline Immunochemotherapy in Follicular Lymphoma." In this presentation, the researchers look at the two situations that are most troubling for FL patients: transformation and POD24. First, POD24 stands for "Progressio of Disease within 24 months." FL patients with POD24 are those who have received immunochemotherapy (like R-CHOP or R-Benda) and then have their disease get worse with the next 24 months. About 20% of FL patients will fall into this category. Transformation happens when our nice slow-growing cancer turns into a different type of lymphoma, one that is fast-growing. Both POD24 and Transformation lead to a lower Overall Survival rate. The researchers here show some evidence that there is overlap in these two groups. That is, many patients with POD24 also have transformed disease. But in looking at the bigger picture, they are being counted twice. In other words, look at 10 FL patients and see that 2 have POD24 and 2 have Transformed disease, but really it's one of each, plus one with both -- 3 patients instead of 4. That matters when statistics are put together about POD24 -- maybe the Overall Survival numbers are better of patients with Transformed disease are separated out from those POD24 patients who have not transformed. Dr. Leonard wants to see the details of the research next week, but thinks this could put even more emphasis on Transformed disease. POD24 is really a label that needs to be separated into at least two groups. It will be interesting to see what the Lymphoma experts have to say about this presentation later on. It's a big deal if it ended up #1 on the Leonard List.

Dr. Leonard also gives 5 bonus presentations on the podcast, and FL makes an appearance here, too. It's one that I have already written about a few days in the blog-- "782 Travel Burden and Travel Costs of Bispecific Antibodies in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Relapsed/Refractory Follicular Lymphoma. I am pleased that Dr. Leonard chose a study that looks at Quality of Life and the time and money that comes with treatment, even apart from the cost of the treatment itself. As Dr. Leonard says, "My takeaway is just that this is a factor that is interesting and important to our patients and something we don't take into account and probably we should be thinking about a little bit more. Taking 50 or 80 hours or longer out of work or other things you have to do if you're a family member or a patient, and the cost of $2,000 and $3,000 in some cases for patients to travel, this is a burden of care that we don't always think about in our practice and probably should be paying some attention to."

Excellent analysis, Dr. Leonard.

So there's the Leonard List for 2024. Follicular Lymphoma played a pretty big role this year, bigger than most years. I'm pleased I was able to describe a few important studies all at one time for you. 

I'll try to get one more preview in before the meeting starts at the end of the week. Once that happens, the previews are over and the reviews begin. I'll report on what the cancer news websites are excited about, and what the experts have to say in the days and weeks after the meeting.

Stay tuned for more.

ASH Preview: A "Triumph" for Tafasitamab

OK, this next ASH preview is an interesting one, not just because of the content of the presentation, but also the situation surrounding it. 

The presentation is called "LBA-1 Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Results from a Phase 3 Study (inMIND)." The "LBA-1" means "Late Breaking Abstract," one that was added very recently, so it's not part of the regular numbering system.  

The abstract describes a very successful phase 3 clinical trial in which Tafasitamab, a monoclonal antibody, was added to the already well-known combination known as R-squared (Revlimid and Rituxan). An article on the Fierce Pharma web site says it "triumphs," which is why I used that word in my title for this post. It will likely go to the FDA for approval as a treatment for relapsed/refractory Follicular Lymphoma.

Before I get into the specifics of the trial, I want to explain why I think the situation is so interesting.

It's partly because I had no idea this was coming. I'm not an expert, as I have said many times before. I'm not an oncologist or a cancer biology researcher. I'm a Cancer Nerd, someone who was diagnosed with FL in 2008, and who reads and writes a whole lot about FL. I'm not an expert, but I consider myself pretty well informed when it comes to Follicular Lymphoma.

And yet, when I saw this headline on Fierce Pharma, I had no idea what Tafasitamab was, or that it was close to finishing a phase 3 trial.

The other reason it's so interesting is that I immediately searched this blog to see if I had written about it before and had just forgotten about it. And I found one post from the past that I had written. This how that post, written April 22, 2021, started out:

I like surprises.And I have to admit, this one surprised me. As much as I follow what's happening in the world of Follicular Lymphoma, I think this is the first I've heard of Tafasitamab. I searched the blog, and couldn't find any mention of it anywhere. But a phase 3 trial is just starting, looking at Tafasitamab combined with Lenalidomide (Revlimid)  and Rituxan (the two treatments that make up R-Squared). The trial involves patients with Relapsed and Refractory Follicular Lymphoma (they've already had at least one treatment that didn't work or stopped working).

 I laughed out loud when I read that. Apparently, I have heard about this treatment twice -- once at the start of the phase 3 clinical trial, and now at the end of the trial. 

This probably says more about the treatment and its maker than it does about me. Tafasitamab is also known as Monjuvi, and it was approved for use on DLBCL by the FDA in 2020 and by the EU in 2021. So it had already gone through all of the really heavy marketing and advertising that would have put it in the news. By the time I read about it, and especially since it was in a trial as part of a combination, it wasn't so "in your face" as it probably was its first time around.

So on to that "triumph" of a trial.

Tafasitamab is a monoclonal antibody, like Rituxan. But it's different in a couple of ways. First, it is "humanized," meaning it was developed from human cells, not mouse cells, like Rituxan. That has the potential to make it more effective and safer )fewer allergic reactions). The second difference is that is targets CD19, a protein on the FL cell. Rituxan targets CD20. So you have two different ways for an antibody to get to the cell. 

Tafasitamab has already been approved in combination with Revlemid (also known as Lenolidamide) for DLBCL. So you had the potential for a really great combination -- everything works together, compliments each other, and should have few new serious side effects,

And that's pretty much what the Tafasitamab + Rituxan + Revlimid combination does. The trial involved 548 patients with r/r FL. Half were given R-squared, and the other half had R-squared plus the Tafasitamab. 

The results were great. The patients in the TRR group had a median Progression Free Survival (their disease did not get worse) of 22.4 months, versus 13.9 months in the RR group. And that increased PFS was true no matter what group they looked at  -- POD24 patients, those who had received Rituxan, rhose who had recieved multiple treatments. The Complete Response Rate for the TRR group was 49.4%, versus 39.8% for the RR group. The Overall Response Rate was 83.5% versus 72.4%. 

As for safety, the results were similar for both groups. 99% of patients had some side effects in both groups (not a surprise). Grade 3 or 4 side effects happened in 71% of patients in the TRR group versus 69.5% of RR, and serious side effects were 36% versus 32%. During the study, 15 patients in the TRR group died, 5 because of disease progression and 6 because of side effects, versus 23 in the RR group (17 due to disease progression and 6 from side effects). Those death statistics are a good reminder that no treatment is without side effects, often very serious side effects.

But the bigger picture is this: adding Tafasitamab to R-Squared makes a very good treatment even more effective, and without a great increase in safety issues. 

I'm guessing this is going to be the Big Story about Follicular Lymphoma when the ASH conference is over, and we'll be hearing more excitement about it from the experts who give their opinions about things. The conclusion to the presentation abstract says this combination "represents a potential new standard of care option for patients with R/R FL." In other words, this will be the one everyone defaults to. That's a big claim. We'll see how the FDA process goes. But it will be really interesting to see what the experts have to say. Those are some very good numbers.

More to come, about this treatment and others.

ASH Preview: Travel Costs for Treatment

The Follicular Lymphoma Foundation has left their survey open for a few more days. Click here to fill it out, and be sure to ask your caregivers, spouses, and partners to fill it out as well. 

I bring this up for two reasons. First, because I want people to take the survey (especially caregivers, whose voices aren't usually heard). But second, because one of the features of the survey involves how long you'd be willing to travel to receive a treatment. It's a really interesting question that doesn't get asked much. For someone like me, with a medical school,and cancer center pretty close by, this isn't a big deal. But for lots of folks, travel to a cancer center can take a very long time, especially for a newer or more complicated treatment that can't be done in a doctor's office treatment room (something like CAR-T comes to mind).

So I'm highlighting an ASH presentation that looks at this problem: "782 Travel Burden and Travel Costs of Bispecific Antibodies in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Relapsed/Refractory Follicular Lymphoma."It's one of those Quality of Life research projects that needs more attention.

The research looks at patients with both DLBCL and Follicular Lymphoma, but I'm going to focus on the FL patients. (The difference between them is in how often they are given this particular treatment.)

Specifically, the research looks at Bispecifics -- Mosunetuzumab and Epcoritamab, which have been aproved for FL. These are among the "newer or more complicated" treatments that aren't available in every treatment room, so some patients with FL need to travel to get to them. Travel costs money, but it also costs time -- time in the car, in the treatment room, and away from a job. 

The researchers looked at 114 patients with FL and DLBCL over a year. They looked at the distance that the patients had to travel to get to their treatment, and how much time it took. Then they calculated the financial cost by applying U.S. government standard mileage rates (the amount per mile that people can be reimbursed for in some jobs) and how much money they lost from missing work (using average wages).

Because Mosunetuzumab and Epcoritamab require different schedules, they figured out how many doses each would require over a year, and calculated them separately.

So what did they find?

The overall average one-way distance traveled was 80.1 miles, and took 84.5 minutes. About 56% of the patients traveled less than 30 miles and 24% traveled more than 60 miles.  

When they added things up, the FL patients who had Epcoritamab traveled 4486 miles over 70 hours, costing the, $5758. The patients who had Mosunetuzumab traveled 3,044 miles for 54 hours, costing them $3907. That's significant.

I don't think the researchers are saying Mosunetuzumab is better than Epcoritamab because of the costs associated with travel. That's a very individual thing -- for someone like me, close to a cancer center, where I could receive either one, the costs probably don't matter all that much. The larger point is to make oncologists aware of these costs -- in money and time -- and to make sure they are a part of the conversation that they have with patients about treatment. It's easy to look at an article in a medical journal and say "My patients have a choice of treatment, and X looks like it is 5% more effective that Y, so that's what I will recommend." That 5% difference might not mean much if there's a 2 hour drive involved every week.

(And that, of course, is exactly what the FLF survey is getting at -- trying to get enough data to show oncologists that these things matter to patients, and that Quality of Life should be a part of any treatment decisions that they make.)

It complicates things for everyone when you start bringing in more factors to consider at treatment time. But it's so important to get that bigger picture. 

I'll keep looking for interesting Quality of Life research in the ASH abstracts, along with interesting research on treatments. Look for more soon.