Two Approvals and a Story

My email notifications have been very busy over the last few days, with news of treatment approvals in the US and in Europe. If I get that many notices, it must be a big deal. I'll tell you about them, but first, a story.

A couple of days ago, I went for my first CT scan in many years. It wasn't for cancer, but for a heart-related issue. (Everything is fine -- just needed to check on something to make sure it really is fine.)  I haven't had a cancer-related scan in a while because I haven't needed one, and my oncologist is pretty firm in his belief that if there isn't a reason to do a scan, we shouldn't do one. "Surveillance" scans, just looking to see if there are any problems, don't usually work that way. Something else happens that calls for a scan, and the scan confirms the problem. 

So that's what happened with my heart-related issue -- something else showed a problem that CT scan could confirm. It was different than any of my cancer-related scans. It was just a CT scan, not a PET scan, so there was no nasty liquid to drink, no IV with a contrast in my arm, no getting undressed. Just me on a table, gliding into a big donut. It took about 5 minutes. 

I've been so busy lately that I really hadn't had time to even think about getting this scan. So it wasn't until I was on the moving table that I even thought "Wow -- it's been a long time since I had a scan. I really don't like scans. There is way too big a chance that a scan is going to bring bad news." That little bit of scanxiety didn't kick in until I was in the middle of it.

And then the voice came on, the one that gives you instructions. So a male voice started speaking to me: "Take a deep breath....now let it all the way out.....take another breath.....now let it all the way out......Now breath in deeply and hold," but his voice went way up when he said "hold," like he was asking a question. Then he continued, "Now you may release your breath." This happened three times.

I almost messed up the scan because I started laughing a little.

The whole "hold" like it was a question was kind of funny. But then I started thinking about the last scan I had, several years ago, at my cancer center. The voice that spoke to me there had a British accent. So instead of saying "Now you may release your breath, " the British voice said "Carry on breathing."

"Carry on breathing" is not a phrase that we use in the US. I remember telling my kids about it, years ago, and them thinking it was very funny. 

So there I was in the CT machine, already smiling at the guy say "hold" like it was question, and now I'm also thinking about the British guy saying "Carry on breathing," and I know I'm about to laugh out loud and ruin this whole scan. 

Thankfully, I was able to hold in my laughter until I was done (thank goodness it was a short scan). But I did tell the technician about it, since she was looking at me funny when I was chuckling a little bit when she came back into the room. She thought it was amusing.

So it's nice to be in a place where I can laugh during a CT scan. I hope that's someplace we can all be someday, with no worries about anything. 

***************

Now, on to those approvals.

The first is from the US. The FDA approved Epcoritamab for two different situations involving Follicular Lymphoma.  

Epcoritamab is a bispecific, attaching itself to B cells with the CD20 protein, ans then to a T cell (an immune cell) with the CD3 protein. In this way, it brings the immune cell close to cancer cell, so the immune cell can take out the cancer cell. Epcoritamab was accelerated approved by the FDA for relapsed/refractory FL in 2024. Accelerated approval is kind of temporary, allowing the treatment to be used on patients while additional data is collected. So the first of the two new approvals is making the accelrated approval into a permanent approval. Epcoritamab can be given as a single agent for patients with Relapsed/Refractory FL who have had at least two treatments already.

The second approval is for Epcoritamab to be used with R-Squared -- Rituxan and Revlimid/Lenalidomode. R-Squared is being used more and more as a substitute for traditional chemotherapy, so just as there are combinations of chemo with new agents, there are also combinations with R-Squared. The potential problem with that kind of combination is that with three treatments, you have the potential for triple the side effects. In fact, safety was a concern when research on Epcoritamab was presented at the ASCO conference in 2024. But apparently there was enough data to lessen those concerns.

So we have a couple of more treatment possibilities in the US. (It has already been approved in Europe and Japan.)

The second approval is for Tafasitamab in Europe. This isn't a full approval just yet, but it's very close. This approval is the last step before it becomes official. It was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which approved it for use with (again) R-Squared for Relapsed/Refractory FL who have had at least one other treatment. It needs to get its final approval from the European Commission.

Tafasitamab (also known as Monjuvi) is a monoclonal antibody, like Rituxan. But unlike Rituxan, which binds to the CD20 protein, Tafasitamab binds to the CD19 protein. So in theory, it should work well with R-Squared, since it works in a slightly different way. The same potential problems with safety can happen with this combination, but the clinical trial data seems to show that it was OK. Given how many notices I received about this, it seems like there won't be any major issues with it getting approval from the European Commission. 

I know that there is going to be some new data for Epcoritamab at ASH in a couple of weeks. I haven't looked to see if there will be anything new for Tafasitamab. I know I need to get moving on ASH previews. I hope to have some for you soon.

Dealing With Fear of Cancer Recurrence

The journal JAMA Network Open just published a study called "E-Health Intervention for Fear of Cancer Recurrence: A Randomized Clinical Trial." To me, the details matter less than the lesson that we should be reminded of.

The study looks at survivors of Colorectal Cancer, not a blood cancer. In this trial, 95 survivors were divided into two groups to measure their fear of their cancer returning (certainly something that we can all relate to, no matter which of our body parts was affected by cancer). All were given something called the Fear of Recurrence Inventory (Short Form). You can see the Inventory here -- it asks questions about how anxious one is about their cancer returning, using a scale of 0-4. With 9 questions of the form, the lowest possible score is a 0 (no fear at all), and the highest is 36. 

One group was given a specific intervention, the one that was being tested. It involved 6 modules that included written responses from a trained therapist, "delivered remotely, individually, and asynchronously over 10 weeks." In other words, the survivor didn't meet with a therapist, but was given personal written responses online to their fears and concerns. The other group was the control group. After taking the Inventory, they were given a diagnostic interview and then referred to a website with self-help exercises (no therapist gave them personal advice).

The trial found that the first group, who got the help from a therapist, had a much more successful time lowering their fear of recurrence. Between the two groups, there was a difference of about 19 points at the end of the trial (on that scale of 0 to 36). The score from the Inventory that signals a need for intervention is only a 3. By the end of the study, 81% of the first group has scores below 3, while only 43% of the second group did.

It seems like the trial showed that the specific intervention was very helpful for that group of Colorectal Cancer survivors.

But stepping back a little bit, I think it's a great reminder for all of us.

Sometimes we can deal with our own cancer-related mental health problems. And sometimes we need some help. 

In some ways, it's hard to compare Follicular Lymphoma patients/survivors with those who have had Colorectal Cancer -- or most cancers, really. Folks with other cancers have that whole "5 year" thing, where they can be told that they are likely cured after that time. That's harder for us. We have it drilled into our heads that our cancer is "incurable." I'm not sure what that means, and it's awfully hard to measure it with a cancer that is slow-growing and that typically gets diagnosed when folks are on the older side. But I think it's true for most of us that we understand that we'll likely live with this cancer for the rest of our lives, whether it comes back or not. (And remember I'm saying this as someone who was diagnosed almost 18 years ago and hasn't needed treatment in almost 16 years.)

There's a different type of mental burden for us, but it's a burden none the less. I know for me, personally, it has gotten easier over time to not think about it coming back. But it's always there, quietly lingering, and some days, it comes back loudly. But I've learned to live with it. 

My point is, there might be times when we can deal with the fear on our own. And there might be times when we need some help.

And it's OK to need some help. 

Even if it doesn't involve us directly, this study shows that there is lots of help available, and it can come in many forms. It might be, like in this study, getting written responses online from a professional. It might mean seeing a professional face-to-face. It might mean being part of a support group at our cancer center. It could mean being part of a support group online.  It could be something as simple as having coffee with a friend or loved one and talking.

I'm a big believer in talking about what we fear, and I think sometimes we need the reminder that it's OK to seek help when we need it. 

Where I live, the leaves are changing, the days are getting colder, and the songs about Santa Claus are starting to show up in stores. It's a joyous time for a lot of people. 

But it;s a stressful time for lots of people, too. A good time to start paying attention to how you're feeling and what you might need to do about it.

So this is just a reminder. If you need help, it's OK to ask for some.  

I hope everyone is doing well.  

50 Years of Lymphoma Lessons

I like to think I've learned a lot in my almost 18 years as a Lymphoma patient. Of course, I'm not an expert -- not like the actual doctors and researchers who have made Lymphoma their life's work. But I've read and written enough to know that there have been some major changes to the Lymphoma world since 2008.

But someone who has seen all of that and so much more is Dr. Bruce Cheson.

If you're a long-time reader of the blog, you might recognize his name. He is a now sort-of retired Lymphoma expert. I linked to him a lot because he wasn't just a well-known and influential researcher (he was responsible for introducing Bendamustine to the U.S.), but because he was very good at explaining things in a clear and often entertaining way. (I have a memory of him making a presentation at a conference somewhere with a glass of wine on the podium as he speaks.)

Dr. Cheson retired a few years ago, though he's still very active in many ways in the Lymphoma community.

A couple of weeks ago, he published something in the ASCO Post, the blog for the American Society for Clinical Oncology. The piece is called "My 50 Years in Lymphoma: Lessons Learned?" 

From the title, I expected a celebration of all of the progress we have made in 50 years in treating Lymphomas. But it's not quite that -- it's more of a list of the things that the research and treatment community still needs to make better.

He looks at different elements of the Lymphoma diagnosis and treatment spectrum -- classifying it, staging it, grading it, treating it, and deciding how successful the treatment was. For each, he gives a brief history (something a Cancer Nerd like me finds very interesting).

But he also points out how stuck we are in the past in many ways.

Take FLIPI for an example, which he discusses under "Prognotic Scoring Systems. I sometimes get emails or comments from readers asking me what FLIPI is, so I've seen how confusing it can be. FLIPI is the Follicular Lymphoma International Prognostic Index. Originally, FLIPI was used to categorize patients in clinical trials. The idea was that using a kind of "quiz" could help make sure everyone in the trial was basically the same, as far as their disease goes, so the can be more easily compared to one another. It doesn't make sense to see if a treatment worked on an asymptomatic stage 1/grade 1 patient who is 40 years old and then compare it to a 70 year old with stage 4/grade 3 bulky disease. So the FLIPI used categories like age, stage, and LDH levels to give a score from 1 to 5. A score of 0 is "low risk" and a score of 5 is "high risk."

One of the problems with FLIPI is that it is sometimes used by patients to guess their future. The link above will take you to a quiz that gives you a FLIPI score and prognosis. A score of 0 means you have a 70% survival rate for 10 years -- at least according to the quiz. A score of 5 means your 10 year survival is about 35%.

But the FLIPI is so general that it really tells you nothing about YOU as an individual. There are so many more factors that determine your situation than something like age. FLIPI is not a crystal ball. It cannot predict YOUR future. 

Back to Dr. Cheson. As he pints out, different versions of FLIPI have been prposed over the years, like FLIPI2 and FLIPI-m7, which looked at other biomarkers, but which really never caught on. (It was tried out on larger groups of patients and found that it didn't really hold up. Biomarkers have always been an issue for FL.) For Dr. Cheson, the problem is kind of the opposite of the one that I point out (which is that FLIPI probably makes your future look worse than it is). For him, the problem is that FLIPI doesn't accurately identify high-risk populations. It's that biomarker problem again. Being over 60 doesn't make you higher risk. It makes you average. 

He thinks most prognostic systems like FLIPI are decades old and do not reflect what we have learned about Lymphoma biology (despite the attempt at FLIPI-m7). They are useless in helping a clinical oncologist figure out the best way to treat a patient. And certain factors have changed with more effective treatments. Have three sites with swollen nodes instead of four sites doesn't change the recommended treatment. It's really not helpful -- not for patients who are worried about their futures, and not for the doctors who are trying to help them. 

Dr. Cheson points out lots of other things that are similar -- old habits that don't really apply any more. 

The question is, what to do about it? 

For Dr. Cheson, the answer is "a revolution": "To improve patient outcomes, a revolution is clearly needed for integrating staging, prognosis, treatment, and response assessment in the context of the remarkable proliferation of exciting new, nonchemo therapeutic agents for lymphoma." 

I hope the solution isn't quite as drastic as a revolution would suggest. But I can also see where someone like him, with a 50 year perspective, would think so. There is so much exciting news in the world of treatment that the basics of diagnosis and staging still haven't caught up with it. 

Here's hoping that revolutionary spirit spreads through the whole Lymphoma community.

Bispecifics vs CAR-T: The Difference in Cost

Good news: It's November, so the ASH abstracts are now available online.

For those who don't know or who need a reminder, ASH is the American Society for Hematology, and every year in early December, they hod their annual conference. It's the largest gathering of blood cancer specialists in the U.S., so there is usually some good research on Follicular Lymphoma that is presented. 

I haven't had a chance to look deeply into the abstracts yet, but I will soon. And as I usually do, I'll try to write about some the research that interests me and that I think will interest you, too. 

I've been so busy lately that I actually forgot that ASH was coming up soon. I got an email from Wendy, a very well-informed reader who reminded me that it was coming up.

And that reminded me to look at some of the links I have been collecting for the last month or so. I'm assuming there will be more research on bispecifics and CAR-T, the two treatments that, in my opinion, are the ones that get blood cancer specialists the most excited.  

One of those links that I saw very recently was about a presentation at the Academy of Managed Care Pharmacy (AMCP) Nexus, a gathering of pharmacists in managed care networks. Managed care refers to health care systems that aim to manage costs while not sacrificing quality. That's the aim, anyway. The important point is, the folks at this conference are as interested in how much a treatment costs as they are in how safe or effective it is.

The presentation that caught my eye is called "Total Cost of Care and Adverse Effects Assessment of Bispecific T-cell Engagers and Chimeric Antigen Receptor T-cell Therapies for Relapsed Refractory Follicular Lymphoma." The point of the research was the heart of what I said about managed care -- it wanted to look at how bispecifics compared to CAR-T, in effectiveness and safety, but also cost.

 I probably could have predicted the outcome of this. CAR-T is an exciting development in treatment, but it's also very expensive. The cost, when it was first approved, was about $500,000, give or take $100,000. That's a lot of money. I was in a meeting recently with some other FL patients, and one mentioned that she had been told that CAR-T, without health insurance, could cost as much as $2 million. (I don't know if that's true, but it certainly made me take notice.) 

In the research from this conference, the researcher looked at TCOC -- Total Cost of Care. That would help the high cost of CAR-T make sense. CAR-T is a personalized treatment, in which T cells are removed from a patient, changed in a lab, and then put back into the patient. That personalization is going to add to the cost. In addition, because of some potentially dangerous side effects, CAR-T patients are typically admitted to the hospital for as long as two weeks -- another factor adding to the cost. 

For some health care systems, that might make the treatment worth the cost, if it is so effective that the patient will never need another treatment again.

Ultimately, the study found that bispecifics might be a better choice for managed care. That is, they can be as effective, and as safe, but cost less. 

The Total Cost of Care for the CAR-T patients in the study averaged $702,000, while the bispecific patients' average total cost was $372,000. The total cost of the drug itself (as opposed to including hospitalization and other costs) was $521,000 for CAR-T, and $183,000 for bispecifics. 

The researchers also found the cost included having to deal with side effects. 52% of the CAR-T patients had significant side effects, adding about $9000 to the cost of care, while 23% of bispecific patients had side effects that added about $500 to the cost. 

(If you're not in the U.S. and all of these costs confuse you, try using a currency calculator. I'll post one here for your convenience, but there are plenty online.) 

I really hate thinking about treatment in terms of cost. I'd much rather write about the happy news that a brand new treatment had a 90% Complete Response Rate with manageable side effects. And that's what I usually write about.

But I know it's not the reality. I know many of us get certain treatments because if someone else is paying else is paying for them, they want to spend as little as they can. And that's true whether it's a private insurance company like in the U.S. or a public system like in Canada or the U.K. And I also know that sometimes I write about exciting new treatments that aren't even available in some countries -- at any cost -- because the cost is so high that it's not worth even making them available.

So it's probably good to know some of this insider information on how much things cost and how decisions get made.

One of the frustrating things about FL treatment is that there are no easy answers, no one clear path for treatment. It would be great if we could say the first line treatment should be X, and then if a second treatment is needed, it should be Y, etc. We don't have that certainty. There are lots of treatment options available that can do a good job.

But maybe there's some comfort in that, too. Maybe if we think a certain treatment that excites our oncologist would be the right one for us, but which a payer refuses to pay for, then we know there are other options. They will be less expensive, and maybe less effective, and maybe with a few more side effects. But we have options, anyway.

That's not necessarily the happiest way to think about it. But it's certainly realistic. And cancer makes us all realists.

I hope it's a long time before you need to make any tough choices. Take care.

  

Restoration

 Hello all. I want to let you know about a new piece that I have written that was just published in Intima: A Journal of Narrative Medicine.

It's called "Restoration," and I have to say, even with as much as I write, I'm more proud of this piece of writing than I have been of anything I have written in a long time.

I won't spoil it for you, but I can tell you that the "restoration" in the title refers to two things. The first is furniture restoration. It's a hobby of mine -- finding old wooden furniture that someone is throwing away, and  fixing it up, either to keep or to donate to someone else who might need it. "Restoration" of furniture is about trying to bring the furniture back to what it once was, before age and use made it something different.

"Restoration" also refers to our attempts to restore ourselves. As cancer patients and survivors, sometimes we wish that things could go back to the way they were, before diagnosis, before treatment, before everything else that comes with cancer. But furniture can never really be "restored." You can never bring it back to the way it was when it was created, as much as it might look like it used to be. And it's the same for us -- we can never really be the person we once were. And that's OK. Sometimes "renovation" is good enough for an old chair or side table -- making it something new, not making it was it was. And maybe we're the same way ourselves.

As I said, I was really happy with the way it turned out, because it was an idea that I had been turning over in my head for a long time, trying to make sense of it. I was finally able to say what I wanted to say, in the way I wanted to say it. I hope some folks find it valuable. Writing is good that way.

So if you'd like to read it, you can find it here. Thanks for clicking.

More Follicular Lymphoma stuff coming very soon. 

Take care.  

Music Therapy for Cancer Anxiety

My most recent email from CURE Today had an article on a recent clinical trial that looked at the benefits of music therapy on anxiety in cancer survivors.

The trial results were actually presented at the ASCO conference in the spring. The presentation was called "Music therapy versus cognitive behavioral therapy for anxiety in cancer survivors: A telehealth-based randomized clinical trial." In the trial, 300 survivors of different types of cancer were split into two groups. All of them had reported anxiety for at least one month. (It probably was not hard to find cancer survivors with some anxiety.) The people in the first group were given Cognitive Behavioral Therapy. (You can read more about CBT here; in the trial, it was considered the standard of care -- the treatment that most people would get if they had anxiety.) The folks in this group met with the therapist once per week for seven weeks by Zoom or other telehealth system.

The other group had music therapy once a week for seven weeks. A separate description of the trial said this consisted of "custom treatments" created by a music therapist "that may involve listening to music, singing or writing a song."

The results showed that the music therapy was non-inferior to the CBT. In other words, the folks in each group experienced about the same reduction in anxiety. The goal of the trial was to show non-inferiority, not superiority. In other words, the researchers wanted to show that both options were useful, rather than showing one was better than the other. CBT works, but some survivors can't do, or don't like it, so having another options -- especially one that is convenient because it can be delivered virtually -- is important. 

One of the big conclusions of the study is that Music Therapy has a long-term benefit. Listening to music, or singing, or writing a song can have a short-term effect that we've probably all experienced.  Your favorite song comes on (Maybe Lizzo's "Good As Hell," to give a completely random example), and it makes you feel good to hear it or sing it or dance to it. But doing it consistently, or time, can have positive effects on anxiety as well.

 I write about music here occasionally. I'm one of those people who remember song lyrics. I'm getting to an age where I forget why I walked into a room and have to turn back around and try to trace my steps and thoughts to remember. But I can sing all the words to the theme song from the TV show "Hello Larry" from when I was 12. So I have millions of words stored somewhere in my brain that show up at times without my asking. Some songs kind of haunt me. They have innocent lyrics that make me think about difficult things. And some that are just fun and make me happy. And some that are really sad, and I like them too, because they can make me sad for just a few minutes and kind of get it out of my system. (Aristotle figured all of that out about 2300 years ago.)

All of this got me thinking about conversations I've had with other cancer patients and survivors who have told me about their favorite Cancer Songs, the ones that they listen to to when they need that short-term boost. Many of them of meant to be inspirational. Some seem to have no connection to the idea of trying to pick yourself up. And a bunch of them, I confess, are songs that I don't like at all, and if I had to hear them every morning to inspire me to face the day, I'd probably stay in bed. What inspired one of us doesn't inspire all of us -- and doesn't need to.

I'm going to share the Cancer Song that I enjoy most.  I've shared it here before. It's called "Swim" by a band callad Jack's Mannequin. Their lead singer and songwriter, Andrew McMahon, is a survivor of Acute Lymphoblastic Leukemia. The song is about trying to stay afloat when things are difficult. You can read the lyrics here -- it's pretty easy to believe it was written by someone who had been given a cancer diagnosis.

So here's my question for you -- what's your Cancer Song? What music inspires you when you're having one of those tough days? Share in the comments. I'm always looking for new inspiration.

And this research is a good reminder that you don't have to struggle alone when things seem overwhelming. The trial is about survivors, but remember that anyone who has been diagnosed, and is still alive, is a survivor.  If you're having a bad day, and putting on some music makes you feel better, that's fantastic. But if things seem overwhelming, and Taylor Swift isn't helping, it's OK to find help. The study is about people working with trained therapists, not about people trying to do it alone. 

Take care of yourself.

 

FDA Fast Track Designation for EO2463

Last week, the FDA grated Fast Track designation for a new immunotherapy treatment called EO2463. (It will probably get a cooler name soon.)

Some reminders before we go any further: Fast Track designation means that a proposed treatment has the potential to do something new, and so it gets extra help from the FDA to help it through the approval process. Its a way of trying to get treatment to a group that has great need for treatment. In this case, that group is Follicular Lymphoma patients. (The news article about this is not clear about the specific population of FL patients, though the National Cancer Institute page for the clinical trial specifies relapsed/refractory patients with FL and some other indolent blood cancers.)

 Immunotherapy is a group of treatments (like chemotherapy is a group of treatments) that uses the body's immune system to work against the cancer. Our immune systems are usually good at fighting off invaders, like bacteria or viruses). But cancer cells aren't invaders -- they are our own cells, but they refuse to die like they are supposed to. So immunotherapy treatments usually work by either changing our immune cells to find and fight the cancer c ells, or changing the cancer cells so they can be recognized by our immune system as invaders.

EO2463 is a very interesting treatment that takes a unique approach to identifying tumor cells. It's a little complicated, so I've tried to do a bunch of reading and watching to help me understand it. (This video helped.)

The company that makes the treatment focuses on bacteria in our guts. Gut bacteria is kind of big news these days, as researchers are looking into all kinds of ways that our gut biome affects our health. (Though not all of those claims have solid evidence.)

The role of gut bacteria in this treatment is different. The company uses Artificial Intelligence to identify over 20 million different proteins that exist in the gut. Their AI program can help identify proteins that are very similar to those that exist in the body, especially proteins that exist on certain cancer cells.

That distinction between the gut bacteria proteins and the human proteins is important. The bacteria in our gut play important roles, but they aren't meant to leave the gut. If they do leave it, our immune system takes over. Immune cells are meant to recognize and fight off invaders (like bacteria or viruses). When they encounter one, they eliminate it and then remember it, so if they encounter it again, they can eliminate it very quickly. Gut bacteria are included on that list of invaders. As long as they stay in the gut, they are welcome to hang around, and the immune system leaves them alone.

So we have two things happening here. First, you have gut bacteria that are considered invaders if they leave the gut. Second, you have proteins from the bacteria that are very similar to proteins on cancer cells, like the CD20 protein that is on the surface of Follicular Lymphoma B cells. 

When you put those two things together, you can develop a cancer treatment. Create a treatment that targets CD20 (and some other proteins) but create it in such a way that it tells immune cells that the cancer cell is really a bacteria that escaped from the gut and needs to be eliminated. Because the treatment is engaging an immune cell called a Memory T Cell, which remembers invaders, the thinking is that the treatment will be long-lasting.

[A note to you language nerds: I know that "bacteria" is the plural form of "bacterium," but I'm calling a single one a "bacteria" anyway because I think it sounds better. Shakespeare made up words, too, and it's my blog, so I do what I want.] 

The Fast Track designation was earned by the results of the SIDNEY clinical trial. This is a phase 2 trial involving 60 patients split into 4 cohorts. As I said above, there are several different blood cancers being targeted in the trial. Patients are given EO2463 on its own and in combination with R-Squared or one of its components, Rituxan or Lenalidomide/Revlimid. 

The early results are promising. The first 13 patients have an Overall Response rate of 46%, with no severe side effects. The makers of the treatment see this as a possible alternative to watching and waiting (though it's not clear if they are targeting untreated patients.)

I have to say, I'm kind of fascinated by the approach, using AI to identify possible targets based on gut bacteria. But there are also lots of questions to be answered -- as is always the case with a phase 2 study. My guess is that there will be more information at the ASH conference, which is happening in less than 2 months. 

But Fast Track is no guarantee of success. This is definitely one that I will keep an eye on.