FDA Denies Approval for Bispecific (For Now)

The FDA has denied approval for the bispecific Odronextamab -- for now. In giving the denial, the FDA pointed to problems in the trial, rather than concerns about its safety or effectiveness. 

Some background: Odronextamab is a bispecific, meaning that it works in two parts. It is a monoclonal antibody, like Rituxan. (I keep referring back to Rituxan when I talk about monoclonal antibodies, because it's been around for so long and is so widely used in Follicualr Lymphoma that I assume most readers know what it is.) In fact, it attaches to CD20, the same protein on the surface of B cells that Rituxan attaches to. But as a bispecific, Odronextamab also attaches to a T cell, an immune cell that can help kill off the cancer cell when it comes in close contact with it. If you've been reading the blog for the last year or two, you know that bispecifics are one of those treatments that tend to get oncologists very excited.

Odronextamab (which was known as REGN1979 before it got its official name) was granted accelerated review last October by the FDA. As you may know, accelerated review means the FDA will look at a smaller set of data (maybe from a phase 2 trial instead of a larger phase 3 trial) and make a decision in a shorter amount of time (usually about 6 months instead of about 10 months). They usually grant this faster review because the treatment will provide something that is not currently available to patients, and it will help a larger number of people if they can get access to it sooner.

However, accelerated review is also provisional review. Approval will allow the maker of the treatment to make it available, but they also have to keep up their clinical trials and submit data to show that it really is as safe and effective as it seems in that shorter amount of time. 

For Odronextamab, the original application was based on data from phase 1 and phase 2 trials. The results from those trials were strong. In phase 2 trial, patients with Follicular Lymphoma had an Overall Response of 82% and a Complete Response of 75%. The treatment was durable, with a median duration of response of 20.5 months and median Progression Free Survival was 20 months. Safety was decent, though 100% of the 131 patients with FL experienced side effects, with 78% of them experiencing grade 3 (serious) side effects, including Cytokine Release Syndrome (in over 50% of patients in the trial), low blood cell counts, diarrhea, fever, and joint pain. 

Importantly, the denial of the application is based on numbers of patients, not on concerns about safety or effectiveness. Basically, the FDA wants to see how the treatment works in more patients. They aren't denying the application forever, just until more data can be collected.

Of course, that's not what the maker of Odronextamab wanted to hear. There are actually two types of trials required, one focused on dosing (making sure the optimal amount of the treatment is given) and the other focusing on confirming the results f the earlier trials. The company behind Odronextamab says it is actively recruiting patients for these trials and is working with the FDA to have a new schedule later this year.

A couple of things seem significant to me.

First, this seems like a clear signal that the FDA really is getting more serious about accelerated approvals. With problems coming up after a quick approval, the agency wants to make sure treatments are safe and effective. In this case, they don't seem to be switching to an emphasis on Overall Survival, with all of the complications that would come with it (as William and Peter pointed out in their comments to my post earlier this month). They don't necessarily want new or different data here, just more of it. That seems like a reasonable approach.

Second, this confirms the importance of clinical trials, and patient participation in them. New treatments can't be approved without large trials, and large trials need willing patients. As you meet with your oncologist, add that question to your conversation -- are there clinical trials that would be appropriate for me, if and when I need treatment again? It's important to know what might come next for you, and important to all of us that new treatments have the data that they need to be approved (or not approved, which is just as important).

I'm sure there will be updates about Odronextamab in the very near future -- maybe as soon as a couple of months from now at the ASCO conference. But we'll definitely hear something by the end of the year about what the plans are for trying to get permanent approval.

FDA Priority Review for Odronextamab

Big news in the Lymphoma community -- the FDA has granted Priority Review for Odronextamab.  It's being reported on most of the major oncology news sites. 

Odronextamab is a CD20 x CD3 bi-specific.  As a reminder, a bispecific works like a monoclonal antibody like Rituxan by seeking out a protein on the surface of a B cell called CD20 (just like Rituxan). But it also targets the CD3 protein on T cells, a type of immune cell that will be floating in the blood along with the B cells. A bi-specific will attach to both and bring the T cell in contact with the cancerous B cell and help the immune cell to eliminate it. Right now, the only bi-specific available to Follicular Lymphoma patients is Mosunetuzumab.

The Priority Review is based on phase 1 and phase 2 clinical trial results. I first started writing about Odronextamab about four years ago, when it was still known as REGN1979. The application is for both Relapsed/Refractory FL and DLBCL (that is, the patient's last treatment stopped working or did not work at all). Patients need to have had at least two previous treatments.

Results have been very good. In the phase 2 trial, patients with Follicular Lymphoma had an Overall Response of 82% and a Complete Response of 75%. The median duration of response was 20.5 months and the median Progression Free Survival was 20 months.

As for safety, 100% of the 131 patients with FL experienced side effects (which isn't surprising -- all cancer treatments result in side effects), and 78% of them experienced grade 3 Adverse Events (more serious side effects). The most common side effects were Cytokine Release Syndrome (over half of patients), low blood cell counts, diarrhea, fever, joint pain, and infusion-related reactions. None of the CRS were grade 4 or 5, which are the most serious.

So it seems like the side effects are manageable. 

If you've been reading for a while, you know that bi-specifics (along with CAR-T) are the Lymphoma treatments that get oncologists most excited. Given some of the issues that Lymphoma treatments have been having in the last few years, I would expect a very thorough vetting by the FDA. The target date for a decision by the FDA is March 31, 2024. I wouldn't be surprised if we saw some updated trial results at ASH in a few months; the last time any results were presented was at last year's ASH. And I would expect it to be positive (maybe updated numbers on duration of response).

Definitely one to keep an eye on.

Concerns about Bispecifics

OK, that didn't last long.

I'm not talking about the whole "2021 is going to be so much better than 2020!" (and that's all I'll say about that).

Clinical trials for Odronextamab have been paused for safety reasons.

Odrenextamab is a bispecific that I wrote about just a few weeks ago. Here's what I said:

"Bispecifics have the potential to be even greater than monoclonal antibodies like Rituxan (also known as MabThera) or Obinutuzumab (also known as Gazyva). Lymphoma experts are excited about that potential, and they had lots to say about some of the presentations at ASH. The first was Odronextamab, which has been going by the name REGN1979. I wrote about this last year. REGN1979 is one of those bispecifics that attaches to the cancer cell (through CD20) and to an immune cell (through the protein CD3). The ASH presentation that is getting people excited is called "Odronextamab (REGN1979), a Human CD20 x CD3 Bispecific Antibody, Induces Durable, Complete Responses in Patients with Highly Refractory B-Cell Non-Hodgkin Lymphoma, Including Patients Refractory to CAR T Therapy." 

I won't give any more background about bispecifics (you can go to the link on your own). But here's the problem (which was announced a couple of weeks after the ASH presentation) -- some patients are having issues with Cytokine Release Syndrome (CRS), a potentially deadly side effect. 

CRS can occur with some immunotherapy treatments (it's fairly common in CAR-T). When the immune system has a sudden rush of white blood cells attacking an invader (or a cancer cell that they have been told is an invader), the cells can send out signals (cytokines) that cause more white blood cells to be released. White blood cells are usually good things, since they fight off invaders. But too many, especially all at once, can cause many problems. Some of them are mild, and some are very serious. Enough patients in the Odronextamab trial had more serious versions of CRS that they put a pause on it.

The company developing and testing the bispecific is pausing the trial, not cancelling it, meaning they are not enrolling any new patients. The FDA has requested that trial protocols (basically, the procedures that need to be followed) be changed to account for the CRS.

The important thing to remember is that CRS, while serious, is also fairly common. One of the problems with early CAR-T trials was CRS, in some cases very serious CRS, resulting in death. (Technically, it was a Cytokine Storm, which happens immediately after a treatment, while CRS is usually what they call a similar reaction that happens over time). Researchers made it a priority to look for signs of CRS so they could be dealt with immediately. 

Just my guess (and this is a good time to remind you that I'm not a doctor or a cancer researcher, just someone who reads a lot) -- the trial will be paused for a while but will probably go on with some changes to manage patient safety. 

It's a also a good time to remind you that all treatments have safety issues -- nothing is without side effects. That's why clinical trials exist. They help determine how effective a treatment is, but also how safe it is, and approval only happens when the side effects are determined to be worth the cost, given the effectiveness. I know I sometimes get caught up in the numbers, and focus on things like Response Rates. I have to remind myself to pay attention to safety, and to make sure I'm making that clear to you, too.

We're getting into a little bit of a doldrums period now, where there isn't as much research news to share for a month or so. But I'll keep looking. 

On the other hand, there's a special day coming up soon, so keep an eye out for that....

ASH: Bispecifics for Follicular Lymphoma

More on ASH.

As I said in my last post, now that the ASH conference is over, and companies and researchers have made their presentations and seen the reaction to them, there has been more discussion online about them. I've been seeing a lot of discussion about three things related to Follicular Lymphoma. The first one (which I discussed last time) is the ZUMA-5 trial, which looked at CAR-T for slow-growing, indolent lymphomas like FL. 

The second one is the excitement about bispecifics. A bispecific is a treatment that attaches to two proteins instead of one (which is where the "bi" comes from).

Think of it this way: a treatment like Rituxan is a monoclonal antibody. It works by seeking out a specific protein on blood cancer cells, called CD20. When the Rituxan finds a B lymphocyte (the white blood cell that turns cancerous for us, and which has CD20 on the surface), it attaches to it and kills it. I haven't linked to this in a while, but here's a cool video that shows how Rituxan kills cancer cells. 

I bispecific works in a very similar way, but instead of attaching to one protein, it attaches to two of them. Since we're looking at cool videos today, here's one from Genentech that describes how bispecifics work. Because bispecifics are created antibodies, they can be manipulated to go after cancer in a bunch of ways. For instance, they can attach to two different proteins on the surface of a cancer cell, doubling the chances of the treatment finding the cancer. Or they can find and attach to two different cells -- one cancer cell, and one immune cell, so the immune cell can more easily get to the cancer cell. 

If you've been reading the blog for a while (or if you're just a cancer nerd), you know that Rituxan has played a big role in the jump in Overall Survival for Follicular Lymphoma in the last 20 years or so. Rituxan can do a great job on its own for some people (like me), but really shines when it is combined with other treatments, whether traditional chemotherapy (think R-CHOP or B-R) or non-chemo (think R-squared). But bispecifics have the potential to be even greater than monoclonal antibodies like Rituxan (also known as MabThera) or Obinutuzumab (also known as Gazyva). 

Lymphoma experts are excited about that potential, and they had lots to say about some of the presentations at ASH.

The first was Odronextamab, which has been going by the name REGN1979. I wrote about this last year. REGN1979 is one of those bispecifics that attaches to the cancer cell (through CD20) and to an immune cell (through the protein CD3). The ASH presentation that is getting people excited is called "Odronextamab (REGN1979), a Human CD20 x CD3 Bispecific Antibody, Induces Durable, Complete Responses in Patients with Highly Refractory B-Cell Non-Hodgkin Lymphoma, Including Patients Refractory to CAR T Therapy." 

In this study, 127 patients with Relapsed or Refractory B cell Lymphomas (including 37 with Follicular Lymphoma) were given Odronextamab. The FL patients did well. This was a dose-escalation study, which meant they tried different doses to see which was most effective. For FL patients who received a particular dose, the Overall Response Rate was 93%, and the Complete Response Rate was 75%. The median duration of response was 7.7 months, and the median duration of Complete Response was 8.1 months. Pretty good.

What really got researchers excited, though, was in some of the patients with Diffuse Large B Cell Lymphoma, a more aggressive lymphoma than FL. In particular, there were some patients who had CAR-T, but whose cancer returned. For those patients, the ORR was 33%, and the CRR was 23.8%, with all 5 of the CRR patients still having a response. That's pretty cool, and should provide some hope to that population, especially if researchers find ways to improve on that number. 

Another bispecific that got some attention was Mosunetuzumab.  This bispecific has been getting some buzz for three years in a row now. The presentation is called "Mosunetuzumab Shows Promising Efficacy in Patients with Multiply Relapsed Follicular Lymphoma: Updated Clinical Experience from a Phase I Dose-Escalation Trial." 

Like Odronextamab, Mosunetuzumab is a CD20/CD3 bispecific, attaching to a cancer cell and to an immune cell. This study focuses only on FL patients (62 of them), though all were relapsed or refractory. Numbers were good here, too. The Overall Response Rate was 68%, with a 50% Complete Response Rate. CRR was good for high-risk patients, including POD24 (53%) and the 4 who received CAR-T (50%). The median duration of response was a little over 20 months.

Of course, all treatments come with side effects, and bispecifics are no different. They included many of the side effects that come with blood cancer treatments, including nerve issues and blood count issues. See the links for more information.

I think this all looks promising. I've been especially interested in bispecifics because my oncologist mentioned them as a possible treatment, if and when I need treatment again. (There was a bispecific trial happening at the hospital I go to.) I don't particularly want treatment, but I really like the idea of bispecifics, and the excitement they are generating. 

One complaint -- Follicular Lymphoma treatments roll out pretty regularly, but not so regularly that I can't learn their names.  But these two seem harder than most. I won't complain if they eventually get approved in a few years, but I'm warning you now to look out for spelling errors.

A little more ASH news to talk about. Come back soon.

ASH Follow-Up Videos on Follicular Lymphoma

I think this will be the last of the ASH posts for this year. (Though, who knows? Maybe I'll surprise you with another one.)

Just like every year, there are lots of experts who give their opinion on the research that was presented at ASH. (Real, actual experts -- not just Cancer Nerds like me who have an informed but un-expert opinion about things.)

A lot of the commentary comes in video form. And sometimes the videos are produced during the ASH conference. A lot of times it's the researchers themselves who talk on video for a few minutes. Sometimes it's other experts talking about the research that excited them.

So here are a few videos for you that focus on research on Follicular Lymphoma at this year's ASH.

First up is "Stephen Schuster: Mosunetuzumab Leads to Durable Complete Remissions in Non-Hodgkin Lymphoma." Dr. Schuster discusses the exciting (but very early) results of research on Mosunetuzumab, the bispecific antibody that some see as a less expensive alternative to CAR-T.

Next: "Should we treat patients with high tumor burden FL with a chemo-free regimen?" In this video, Dr. Loretta Nastoupil of the MD Anderson Cancer Center discusses a phase 2 clinical trial that looked at Obinutuzumab + Lanalidomide. Basically, it's R-Squared but with a different (maybe better?) version of Rituxan. Results were very positive and an improvement (maybe?) on R-Squared.

Third is "AUGMENT: Is the combination of lenalidomide & rituximab efficacious in elderly patients with iNHL?" This one does look at R-Squared. There were a bunch of presentations about R-Squared at ASH this year (I already looked at a couple of them, but not this one.) One of the reasons people were so excited about R-Squared being approved for some types of Follicular Lymphoma is that it is an alternative to traditional chemotherapy. As a more focused treatment, R-Squared should do a better job of not killing healthy cells, and will have different (though not necessarily fewer) side effects than chemo. The AUGMENT trial has been looking at a bunch of data from its R-Squared research, and this presentation focuses on elderly FL patients.  Depending on their health, chemo can be rough on elderly patients. R-Squared, according to Dr. Marek Trněný of Charles University Hospital in Prague, elderly patients seem to tolerate R-Squared better than chemo. That's great -- a better option for a lot of patients (since most FL patients are diagnosed around age 65).

Finally, there's "When should patients with R/R NHL receive the bispecific antibody REGN1979?" The bispecific Mosunetuzumab has received most of the big news this year at ASH, but another bispecific also showed good results. REGN1979 is another bispecific (it attaches to two different cells, the cancer cell and the immune cell that  can destroy it) and has also shown some positive updated trial results. Dr. Rajat Bannerji of the Rutgers Cancer Institute of New Jersey gives the results in this video.


Lots of good stuff at ASH this year for Follicular Lymphoma patients. As I said a few weeks ago, there weren't any real blockbusters this year -- nothing that's going to change the way people are treated anytime soon. Mosunetuzumab might have that promise, but it's very early to say for sure.

But even small improvements are good for us.

REGN1979: Bispecific for Follicular Lymphoma

Following up on a comment from William, who linked to an article about the Bispecific REGN1979. Lymphoma News Today reported on the results of a Phase I trial for REGN1979, with very positive outcomes for patients with Follicular Lymphoma.

(I'm going to be shameless for a second, and remind everyone that I write a monthly column for Lymphoma News Today called "Things That Give Me Hope." I might as well make my editors happy and see if I can't increase our readership a little bit.)

Anyway, REGN1979 is a Bispecific, a fairly new type of treatment. The "Bi" in "Bispecific" usually means "two." In this case, it means the Bispecific attracts and attaches to two different proteins. It's kind of like a double-sided Rituxan. As you probably know, Rituxan works by finding the CD20 protein on a B cell and attaching itself to it. REGN1979, as a Bispecific, does just that -- it finds the CD20 on a cancerous B cell. But then it also finds the CD3 protein on an immune cell -- the cells that kill invaders in the blood. By connecting a cancer cell to an immune cell, the Bispecific can bring them together and let the immune cell do its thing.

This study was actually presented at the ASH conference last December. The results then were excellent, with all 7 Follicular Lymphoma patients getting a response (5 Complete and 2 Partial). The Lymphoma News Today article reports on updated results that were presented at the European Hematology Association conference last month. Results are still excellent, though with a few more patients, they are not quite as high: 13 of 14 patients (91%) had a response, with 10 of 14 (71%) getting a Complete Response.

The side effects were "manageable," and included (83% of patients), cytokine release syndrome (57%), chills (54%), and infections (49%), as well as the blood count and nerve issues that are common in FL treatments. Four patients had to drop the trial because of the side effects they experienced, and more had their disease progress. Also, 27 patients dropped the trial due to disease progression and several patients enrolled in the trial died (though this seems to have come from issues unrelated to the treatment itself, but because they already had advanced disease or other health issues, which is not uncommon in phase 1 trials).

I'm interested in Bispecifics (there are a few of them out there in trials) because my oncologist thought I would be a good candidate for a trial for this treatment. I'm sure William was interested in REGN1979 because the article points out that two of the patients who had a response were also former CAR-T patients. As I have been writing about lately, CAR-T works very well for some patients, but not alll of them. So it's great to see that a Bispecific could work for them.

It will be interesting to see how REGN1979 and other Bispecifics work in the longer term, and if a phase 2 trial would show different results, especially in terms of side effects. A significant number of patients had to drop out of this phase 1 trial. But phase 1 trials often include patients who have disease that has progressed a lot, and are willing to try things. That can throw off the results (whoch is why they don't include the entire group, including the drop-outs).

As I said, I'm very interested in this type of treatment. I'm hoping I won't need any treatment for a while, but I'd like to see some updated results at some point in the future.

Bispecifics for Follicular Lymphoma

I've mentioned bispecifics in my last two posts, so I thought I'd look into them a little more.

BioPharmaDive published a nice piece last week called "At ASH, Bispecific Cancer Therapies Make a Mark." It does a nice job of explaining what bispecifics are and why they made a mark at ASH.

Maybe the easiest way to understand a bispecific is to compare it to a monoclonal antibody like Rituxan. Rituxan (as you may know) works by looking for a protein on the cancerous B cell called CD20 and attaching itself to it. From there, it can kill off the cell in a few different ways. (Watch this cool animation video to see cancer cells die.)

The important thing here is that the one side of the Rituxan attaches the the cell.

A bispecific works in a similar way, but instead of attaching with one side, it attaches to two -- the the cancer cell on one end (like Rituxan), but to an immune cell on the other. Like Rituxan, one end attaches to the CD20 protein, while the other end attaches to a CD3 protein on the immune cell. In this way, the bispecific brings the two cells together -- the cancer cell and the immune cell that is meant to kill it off.

There were three bispecifics discussed at ASH that target B cell lymphomas. All of them target CD20 on on end and CD3 on the other.

The first is Mosunetuzumab. In its phase 1 trial, 98 patients were enrolled. 55 of them had DLBCL or transformed Follicular Lymphoma, and 29 more had regular old FL. There was a 41% Response Rate (33% for the DLBCL/transformed group, but 61% for the FL group), with 27% having a Complete Response (21% of the Diffuse/transformed group and 50% of the FL group). Side efefcts were tolerable. The responses even came for patients who culd no longer take Rituxan, or who tried CAR-T but did not have success. The median follow-up for the study was a little over a year.


The second one is called REGN1979. It was also tested in a phase 1 trial, with 54 patients (16 of them had FL). A number of patients had to withdraw from the study because it didn't work, and their disease got worse. Phaee 1 trials focus on side effects (again, they were called manageable) and figuring out what the best dose would be. For patients who had a particular dose (more than 5mg), there was a 100% response rate for FL patients (5 Complete and 2 Partial Responses).

The third is RG6026.  Again, patients were in a phase 1 clinical trial -- 64 with aggressive B cell lymphomas, including transformed FL, and 17 with FL. Again, at a certain dose (300 µg or above), 3 of 5 FL patients had a Response, with 2 of them having a CR. Side effects were manageable.

One of the issues that is discussed in the abstracts is Cytokine Release Syndrome. This is also a problem with CAR-T treatments. When the body has so much T cell activity, the patient can develop flu-like symptoms, and they can be life-threatening. Researchers were aware of this possibility and took steps to deal with it.

The important thing to remember with these, of course, is that they are all phase 1 studies, and they haven't involved a lot of patients. Larger phase 2 studies will be necessary to figure out if they are as effective as they seem, and then even larger phase 3 studies will really let us know.

(Dr. H, my new oncologist, told me that this kind of treatment might be one that I would want to consider. My new hospital is part of the clinical trial for one of the three treatments.)

Interestingly, according to the BioPharmaDive article, one of the people involved in one of the trials thinks the bispecifics might work even better as part of a combination (which is, of course, the direction that lots of new treatments are going in).

However, another person looking at the results was a lot less impressed after looking at the numbers.

Time will tell. Perhaps one or more of them will move on to a phase 2 trial, and we will see how things go.

For now, though, I'll take my new oncologist's excitement about them as a a good sign, and hope for the best.

ASH: New Treatments (Without Rituxan)

Today is the last day of the ASH conference, and I've been too busy to fully enjoy everything that has been happening. I've barely been on Twitter lately, and that's where I get a lot of my ASH news. So I'm behind on reporting what's been happening there.

Before the ASH meeting begins, I get my information by looking at the abstracts to see what kind of Follicular Lymphoma research is being presented. Once the meeting starts, I get press releases and news stories about some of the more exciting presentations. Pharmaceutical companies and universities and hospitals like to brag about their good work. And I like to read it.

So I want to look at some of the good stuff that's been coming out of ASH, but maybe not in as much detail as usual. So here's a good excuse to do that -- a comment from reader Shelly from a couple of days ago:

Bob,
Are you finding any new info on "other" treatments that are showing PFS in patients that DON'T involve Rituxan??? Especially for relapsed.
Shelly

Thanks for the comment, Shelly. Yes, there are some other treatments that don't involve Rituxan. And some of them have been talked about at ASH this year.

Rituxan is kind of a miracle treatment. Overall Survival has increased for FL patients in the last 20 years or so, which is about how long Rituxan has been around. Rituxan seems to make other treatments better, which is why it's almost always included with things like CHOP or Bendamustine. And newer treatments are often tested in trials as part of combinations, very often with Rituxan as a part of the combo.

But some people have allergic reactions to it, and some have used it a few times and it no longer works for them. So Shelly's question about new treatments that don't involve Rituxan makes some sense.

Here are some that have been talked about at ASH this year:

• In a phase 2 clinical trial, a treatment called G100 showed some success when combined with another called Pembrolizumab for relapsed/refractory patients. G100 is an immunotherapy that works on cancer cells to make them more receptive to the immune system. The G100 is injected into the tumor, where it reaches the cancer cells. Pembrolizumab is also known as Keytruda. It goers after the PD-1 receptor on lymphoma cells, and turns of the signal that keeps the cell from dying. In this trial, the combo had a PFS of just under a year (so far). the combo had an Overall Response Rate of 46%, and kept the disease under control for 92% of patients.
• In a phase 1 trial, a treatment called Mosunetuzumab showed a lot of promise. Mosunetuzumab is another immunotherapy -- it activates an immune cell called a T cell to go after the B cells that are causing the lymphoma. In patients with relapsed/refractory FL, the Response rate was 69%, with a 38% Complete Response. This is a phase 1 trial, so it was fairly small, but the treatment does get people excited.
• Another treatment, REGN1979, also showed lots of promise. Like Mosunetuzumab, REGN1979 is bispecific, meaning it can attach itself to two different targets, a T cell and a B cell. REGN1979 was tested in a very small phase 1 study of just 10 relapsed/refractory FL patients, all of them showed a response, with 8 of the 10 showing a Complete Response. The news was good enough to have the developers want to move on to a larger phase 2 trial.

There are more, but that's a good answer to Shelly's question -- yes, there are options that don't involve Rituxan.

A few important things to keep in mind:

First, I'm not a doctor. Talk to an oncologist about treatment options. But take all of this as reason for hope that we will have some good options in the future. (There are some really exciting things happening with immunotherapy.)

Second, remember that a lot of what happens at ASH and other oncology meetings involve treatments in clinical trials. That means they are still being developed and tested. They show promise, but they haven't been approved. It's not uncommon for something to do really well in a phase 2 trial and then not as well in a larger phase 3 trial when it gets tested on more patients. Be hopeful, but be realistic.

Finally, the only way for new treatments to be tested and then approved is if patients sign up for clinical trials. There are a decent number of options already approved for Follicular Lymphoma, but if you do need treatment, talk to your oncologist about clinical trial options, or get a second opinion from someone who knows about them. It may help you, and it will certainly help the rest of us.

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

Once ASH is over, there will be lots of experts talking about what excited them most. I'll keep an eye out for those articles and videos, and pass along the good stuff.