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. 

 

ASH Preview: Statistics on Watching and Waiting

 As I said in my last post, there are a lot of interesting presentations about Follicular Lymphoma  coming up at ASH, and I hope to cover a lot of them. And as I said, I want to start off with a presentation about Watching and Waiting.

If you've been reading for a while, you probably know that I was diagnosed with stage 3, grade 1/2 FL in January 2008. My disease was slow-growing enough that I was able to watch and wait for exactly two years -- I started Rituxan on my second diagnosiversary. The treatment began because of swelling in my leg, probably caused by nodes that were pushing up against something. 

Watching and waiting made absolutely no sense to me when I was diagnosed. Why would anyone choose to not get treatment? But I learned that watching and waiting made sense for some FL patients whose disease was slow-growing, because it essentially delayed using up a treatment. Back then, there were fewer treatments available, and it was assumed that the disease would come back and need another new treatment. The hope was there would be enough treatments, and enough time between them, to outlast the disease.

For a while, there was lots of research on W & W, trying to find some negatives about it. But there was never really anything discovered that upset what the previous research showed -- that there was no real difference in Overall Survival between patients who were treated right away and those who waited. I remember a researcher arguing that W & W was unnecessary because we had more treatments available, and something like Rituxan could be used a s first-line treatment because it was less aggressive than other options. That got debated for a while and then people stopped talking about that.

[I've been writing this blog for almost 17 years, so I don't remember a lot of details, but if you want to be a Cancer Nerd and search the blog for everything I've written about watching and waiting, you have that option.]

So let's take a look at this ASH presentation -- "4416 Practices and Outcomes during a Watch and Wait Approach for Follicular Lymphoma: A Study from the Australasian Lymphoma Alliance."It looks at 267 patients from Australia who were diagnosed with FL and then watched and waited.

It doesn't necessarily present anything new, but it gives an interesting snapshot about what happens when patients watch and wait. Given that I've had a couple of conversations recently about this, I'm guessing there are a bunch of you who are curious about this. Here are the bits that I found most interesting:

• For the patients in the study, the median Time to Treatment was 4.88 years (meaning half of them waited for over 5 years). About 30% of the patients were able to continue to watch and wait for 10 years. That's a long time. (I'm thinking of reader Chip, who was getting a little antsy after 3 years. It can go on for a while, obviously.
• While they were waiting, they had a median of 8 appointments with their oncologists and 2 CT or PET scans.This is pretty interesting, too. I know when I was first diagnosed, and we agreed to watching and waiting, I expected to see the doctor very frequently, and at first I did. But then we stretched out the every 3 months. In this study, if patients waited for 5 years and had 8 appointments, then they were seeing their doctor every 7.5 months. If you're newly diagnosed, keep that in mind -- patients don't need to be seen very frequently, if that's something you're concerned about. The reason is related to the second bit of information here -- only 2 scans in 5 years. Again, I thought I would get scanned every few months. But we shouldn't be exposed to that much radiation -- a scan every year is probably the most frequent you'd need, and even that is a lot of scans. I remember reading a study that said that most patients notice symptoms themselves and then alert their doctor about it.  The new symptoms (like my swollen leg) aren't found in scans or during a doctor's visit. They are found by patients. Why? Because we know our bodies and we know when something isn't right. Trust yourself. 
•  Just to be clear -- the range of doctor appointments in the study was 1 to 34, and the range of scans was 0 to 14. Don't take the median to be the goal. If your doc wants to meet or scan more or less than that, then ask why and if you're ok with the answer, then meet more or less frequently. But it's OK to ask to meet more frequently, if only for the peace of mind (I meet my doctor way more frequently than I need to, even 16+ years later, because it gives me a little comfort.)
• Complications, including patients having new symptoms, happened to 28% of the patients in the study. About 13% of them had transformed disease, where their slow-growing FL turned into a more aggressive type of lymphoma. About 12% had pain or discomfort,  3% had hydronephrosis (swollen kidneys) and 2% had thrombosis (blood clots). Most, it seems, it not have serious medical complications.
  
•  Here's a big one: There was no mortality associated with a WW approach. No one died because they watched and waited. That's worth mentioning. I know I had the fear that I or the doctor would miss something important. That doesn't happen.
• Back to scans. For those who did get scans, about 20% were for "surveillance," basically to take a look around and see what's going on. The other 80% were triggered by "clinical findings," either discovered or confirmed by a doctor;s examination.
  
• During the 5.5 years of follow up, 138 of the 267 patients started treatment -- just over half. For those who did start treatment, 38% did so because of tumors getting larger, 25% transformed, 17% had organ compromise, 7% was for potential organ compromise (I think this was technically the reason I started treatment), 7% had cytopenia (low blood counts). So for those of you who wonder when to start treatment, there are lots of reasons, and I think it's safe to say that you'll know when something is up.
  
•  This is important too: 1 of the 138 patients who started treatment did so by choice. That is, there weren't any symptoms or complications that made the doctor say "It's time to start." The patient said, "I can't do this anymore. I need to start treatment." And that's OK.  Honestly, I'm surprised it was only one. As I have said many times before, we have a disease that has emotional symptoms as much as it has physical symptoms, and for those who are watching and waiting, there are more emotional than physical symptoms. If a treatment results in too great of a physical toll, we stop doing it. If the choice to watch and wait takes too much of an emotional toll, then ask to stop. that's a legitimate choice.
• And finally, it's the same story as I heard 16+ years ago -- Overall survival was similar for watching and waiting than it was for patients being treated. 

So there you have it -- as up-to-date a picture of watching and waiting as we have. If you're watching and waiting now, and you have questions, I hope this answers them. It's such a strange situation to be in, it's only natural to have questions. At least for now, I hope you have something to compare to, and you can see that watching and waiting can be a good choice -- one that won't results in any special problems, as long as you pay attention to your body and let your doctor know when something is off.

There's another interesting watching and waiting presentation that I may write about. But maybe not  -- this one answers lots of questions, and there is so much more to share with you.

Come back soon.

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One final push for patients and caregivers to take that FLF survey. It closes on November 19, so do it soon if you haven't yet!

ASH Abstracts Are Here!

Before I get the Cancer Nerd stuff, I want to remind you about the Follicular Lymphoma Foundation survey that I linked to in my last post. 

The survey is about how patients with FL make decisions about treatment. It should take about 10 minutes to complete, and will provide valuable information that hopefully will be presented at a medical conference next year, where it can be seen by oncologists and researchers and those who manufacture the treatments. 

This link will take you directly to the survey.

UPDATE: The FLF is getting a good response from this survey from patients, but they'd love to hear fro more caregivers -- a spouse or partner or family member or friend who helps you as a patient. If you're a patient, could you please share the link with your caregiver and ask them to take it? Caregivers don't get enough credit for how important they are in the decision-making process. This is a great opportunity for their voice to be heard.

 Thanks for considering it.

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Now, back to that Cancer Nerd stuff.

The abstracts for the ASH meeting are now available!

ASH is the American Society of Hematology, and their annual meeting is the largest gathering of blood cancer specialists in the United States. It takes place in early December every year. This year is it December 7-10.

Much of the meeting involves presentations of research on blood cancers and other blood-related diseases. (It's in San Diego, California, so I assume some of the meeting involves brightly-colored drinks with little umbrellas in them, too.)  About a month before the meeting, ASH published the abstracts -- summaries of what the presentations will be about, so those in attendance can plan out which sessions they want to go to. 

Every year, I like to go through the abstracts related to Follicular Lymphoma and preview some of the more interesting ones. My quick search says there are 329 abstracts for Follicular Lymphoma. You can see them yourself here.  

Some years, there isn't much that's very interesting. But this year, even a quick look at the titles is getting me excited. 

First, though, a few things that I am not seeing in my quick look at the abstracts.

First, I'm not seeing any game-changers. Some years there's a presentation that is so important that they move it to a very big room so they can fit all of the people who want to hear about it. (The last one of those for FL was when they discussed the results of the R-squared trial.) I don't see any of those this year. And that's OK.

I'm also not seeing too many new treatments. There are a few, but not as many as some years. These re usually reports of phase 1 and 2 clinical trials, which means they are very early in their process. They're always exciting, but don't always play out as one would hope, and they aren't heard from again. I do see a few, though, and I'll try to highlight the exciting ones.

What I am seeing is a lot of research on treatments that have already been approved. Some are "real world" studies, looking at a treatment outside of a clinical trial, so there are fewer restrictions on who can actually receive the treatment. Some are combination studies, looking at treatments that have been approved on their own to see how they work together. Some are long-term follow-ups to approved treatments.

Those kinds of presentations are really interesting, too, because they teach us more about the treatment and how effective it is for certain patients. They can be less exciting than a presentation for a treatment that hasn't been approved yet, and that comes with the promise of big change. But those less-exciting presentations often give us incremental change. No big leaps forward, but they do move us forward. And that's a great thing, too.

I'm also seeing some presentations about Quality of Life issues. That's excellent -- researchers are paying attention to it, and oncologists will be hearing about it. There's more to treatment than just how effective it is. There's everything that happens when we live our lives outside of the treatment room. That matters a lot.

I see a couple of presentations about watching and waiting that I'm excited about (and might start off with, since I'm always interested in it).

Finally, there's an "Education Program" about FL that;s in a big room. It's not presenting anything new, just educating oncologists about what the latest is for Follicular Lymphoma. There's one presentation during the session called "Follicular Lymphoma: In Pursuit of a Functional Cure."  The description of the presentation, from Dr. Judith Trotman, and Australian oncologist, says "In this talk, Dr. Trotman will provide the survival data to equip clinicians in framing optimistic initial conversations with most patients at diagnosis of advanced stage FL. She outlines the expectations of longevity and a"functional cure" for many." A functional cure is the idea that many of us will get a treatment that lasts so long that we don't need another, even if we still have some evidence of the disease still hanging around and remaining stable.

That one looks great, and I hope I can get access to a recording of it after it is over. Unfortunately, ASH doesn't provide special registration rates for independent cancer advocates the way ASCO does, so I'd have to pay for access. Maybe I'll get lucky and they'll post the video for free someplace.

So look for some interesting ASH previews in the next few weeks. Always a special time.

(And don't forget that FLF survey! Caregivers, too!)

More to come very soon.

 

Please Take This Survey about Follicular Lymphoma

Hello all.

I'm finally putting up that post that I promised last time. 

I'm linking to a survey here, and I'm asking you to please consider taking it. The link comes directly from the Follicular Lymphoma Foundation, so it is safe.

https://hab.medefield.com/wix/01234/p979123129511.aspx

The FLF developed this survey (I helped a little bit!) to better understand how patients with Follicular Lymphoma make decisions about treatments. It can also be taken by caregivers and physicians to get their input as well. (The survey will direct you to a different version after it asks you if you are a patient, a caregiver, or a physician.)

The survey is open to residents of the United States, United Kingdom, Canada, Australia, and Spain. You can see the survey in English or Spanish. The announcement for the survey is available on the FLF website if you'd like to read a little more about it.

The survey should take about 10 minutes to finish (maybe 15 minutes if you read slowly and carefully like I do). It is completely anonymous.

The survey will first ask you some basic information, and then it will describe the survey methods for a few screens to make sure you fully understand what you need to do. I don't want to give too much detail here, but it will basically ask you to choose between two hypothetical treatments (they aren't real, or even in development). They will distinguish between the two treatments by showing how type are different, in terms of how long you are likely to be in remission, what kinds of side effects are common, and how it is administered. You'll choose the treatment that you would prefer. You'll do that 11 times. 

It's not hard at all, once you read through the descriptions of how it all works. 

The FLF plans to present this information at a future medical conference. They hope the information will be seen by researchers and influence how they develop new treatments. (For example, if the survey showed that patients with FL would overwhelming prefer one way of administering treatments, then maybe researchers will be sure to develop treatments that can be administered that way.)

So this is your way to potentially have a hand in how research gets done in the future. Very cool. 

 

Thanks for taking the survey. It helps all of us.

 

National Workshop: Lymphoma Research Foundation

Well, I have a post that's all written, that I had planned to put up this weekend, but I need to hold off on showing it to you. I'll explain later.

For now, here's a reminder that the Lymphoma Research Foundation is holding its virtual National Lymphoma Workshop on November 16. This is a day-long event, completely online, and it's all about the latest research in Lymphoma ("Understanding Lymphoma Basics and Current Treatment Options").

The workshop is chaired by Dr. Neha Mehta-Shah of Washington University in St. Louis, Dr. Craig Portell of the University of Virginia, and Dr. Carrie Thompson of the Mayo Clinic. I'm not as familiar with the work that Drs. Mehta-Sha and Portell do, but I've written before about Dr. Thompson, who does  a lot of research on Surviorship and Quality of Life. I think she's great. I'm sure the other two will be equally good. 

I attended one of these in the past, and it was excellent. You can expect to hear information that it meant for patients who are newly diagnosed,  those who are relapsed/refractory, and information about survivorship. There will also be a session devoted to Follicular Lymphoma, where they may talk about treatment options, clinical trials, and new therapies. And there will be a chance to submit questions for the experts to answer.

Registration is required. You can find out more details and get the registration link here.

I'll have more for you soon. This is about my busiest time of the year for me, with lots of work stuff, plus some really interesting cancer-related advocacy work that I'm doing. I'll try to share more about it when I can stop and take a breath.

Stay well.