Tafasitamab for Follicular Lymphoma

 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 Follicualr Lymphoma (they've already had at least one treatment that didn't work or stopped working).

Tafasitamab is not new. It was actually approved by the FDA last year as a treatment for Diffuse Large B Cell Lymphoma, in combination with Lenalidomide. The combination of Tafasitamab and Lenalidomide has its own name, and it might be the coolest lymphoma treatment name I've ever heard: Monjuvi. 

The DLBCL approval came after a phase 2 clinical trial, since Tafasitamab was considered a first-in-class treatment -- it works on cancer cells in a way that no other treatment had ever done before. 

Tafasitamab is a monoclonal antibody, like Rituxan (rituximab) and Obinutuzumab. That's why they all end in "-mab" -- short for Monoclonal Anti Body. It's diffeernt from the other two, which both target the protein CD20 on cancer cells. Tafasitamab targets CD19 (the same protein that some CAR-T and bispecific treatments go after -- it's definitely the hot new target these days, the Anya Taylor-Joy of cancer cell targets).

Like Obinutuzumab, Tafasitamabis "humanized," made from human components (Rituxan is made from mice). Tafasitamabis also FC-modified, which means it has been changed so it will do a better job of staying in the blood and finding the cancer cells. (If you want a full, very scientific explanation, you can find one here. I understand enough of it to know that it's an improvement on Rituxan.)

So while this is the first I've heard of it, and it's just the beginning of a phase 3 trial (which means it could still be a few years before FL patients see it become available, it does hold a lot of promise. The trial is planning to enroll 618 patients with FL and Marginal Zone Lymphoma. Half will get the Tafasitamabis + Lenalidomide + Rituxan combo, and half will get just Lenalidomide + Rituxan. As I've said before, it seems like combinations of treatments will be a big part of our future -- several different ways of getting at cancer cells, as long as the combination remains safe. If this combination is moving to phase 3, there has to be some evidence that it is safe and effective.

I take al of this as good news. While I don't like to miss out of things while they are in early stages, it also tells me that there is so much good stuff out there in trials that it is inevitable that I'll miss some. 

That's a good thing.

 

Covid Vaccines and Lymphoma

A couple of days ago (Tuesday), the Lymphoma Research Foundation held a webinar on the Covid-19 vaccination and what it means for lymphoma patients. I wasn't able to listen in live, but I did listen to the recording of it. You can find it here. 

And if you have questions about the vaccine, I hope you'll listen to the recording, which features two experts from Rutgers University, a epidemiologist and an oncologist. I'm going to go though some of the things I thought were important, but I want to emphasize this:

Whether you read what I say below, or listen to the recording, please remember: the best source for advice about any aspect of your cancer is your oncologist. Use the information from this webinar as a first step, not a last step. Use it to begin a conversation with your doctor, not as a substitute for that conversation. As one of the doctors in the webinar says, the information pertains to most cancer patients, but each of us has our own individual situation. Please keep that in mind.

The webinar opens up with information from Dr. Strom, the epidemiologist. He provides some basic information about Covid-19, and then gives some detail about what Rutgers has been doing related to Covid research, testing, and vaccine distribution. (He goes on for a little too long, in my opinion. If you want to move past the Rutgers information, skip ahead to about 14 minutes into the webinar.)

The second speaker is Dr. Evens, the oncologist. His focus is on how the Covid-19 vaccine might affect lymphoma patients. This is the information that most people really wanted to hear.

Dr. Evens begins by reminding us that the Covid virus is serious, and cancer patients in general are at higher risk for death and severe illness if they get Covid-19. To be clear -- that doesn't mean that they will get very sick, just that they (we) are at higher risk. That's based on statistics. Each of us would respond differently to testing positive for Covid. 

I think we all know that, a full year into this pandemic, and I'm sure we've all been especially careful. It's important that we continue to be careful -- wearing masks, staying six feet (or two meters) away from others, and washing our hands often. Even if we do get the vaccine.

As for the vaccine, Dr. Evens gives some general guidance. This is a screen shot from the webinar, but I'll go through it all, too:

First, and most important: When you have the chance to get a Covid vaccine, get the vaccine. There doesn't seem to be any harm in getting the vaccine. It won't hurt you. Chances are very good it will help you. When you have the chance to get a Covid vaccine, then get the vaccine.

Even if you have been diagnosed with Covid, and you think that gives you some natural immunity, then get the vaccine. The vaccine will give you up to 50 times the antibodies that you would get from being diagnosed with Covid.

There are a few instances that need to be considered. Remember -- everyone's situation is different.

For example, patients who have a Stem Cell Transplant or have had CAR-T might do better to wait about 3 months after treatment has ended to get a vaccine. This is because treatments like these (and some very intensive chemo) mess with the immune system, and it can take 3 months to fully recover. The vaccine works by ramping up the immune system and training it to recognize the Covid virus. If the immune system isn't fully recovered from the treatment, the vaccine won't be effective. Once that 3 months is up, it's a good idea to get the Covid vaccine, according to Dr. Evers.

In the same way, Dr. Evers says, if a patient is going to begin treatment soon, it would be a good idea to get the vaccine before treatment, when the immune system is still strong and hasn't been weakened by the treatment. 

If it's possible to delay treatment when you are considering getting a vaccine, that might be a good idea. Some of us can't delay -- the lymphoma is too aggressive. But others of us have an indolent, slow-growing lymphoma, one that might let us delay treatment. Same with maintenance treatments -- good for us, but not completely necessary. If it's possible, says Dr. Evens, delay a treatment until 2 weeks after you've gotten the final Covid vaccine (if the one you are getting requires two doses), so it is working to its full potential.  

Some other important things to know:

• Seralogic tests -- the tests that show if the vaccine has given you a high level of antibodies after you have received it -- are not really reliable.  If you have gotten the vaccine, and you are not dealing with one of the situations above, then you can assume you have a good level of antibodies.
• If you are in a clinical trial, get a vaccine anyway. The only exception might be a phase 1 trial, where safety of the new treatment hasn't been determined. But otherwise, get the vaccine.
• If you do get the vaccine, keep this in mind: about 16% of people who get the Pfizer or Moderna vaccine have swelling in their lymph nodes afterwards. This is a temporary immune system response, and the nodes should return to normal. So don't panic. But also know that you might not want to get a scan for 4-6 weeks, since it might show swollen nodes that aren't cancerous.
• The vaccine will probably not cause a sleeping lymphoma to wake up. (See above -- if your lymph nodes start to swell up, it's an immune response, not a lymphoma symptom.) On the other hand, there have been some reports of blood cancer patients whose cancer seems to get better after the vaccine. But those are still being investigated. 
• The vaccine does not work differently for different lymphoma subtypes. In other words, it's effective whether you have Follicualr Lymphoma, DLBCL, or whatever. 
• Is it safe for a cancer patient who has been vaccinated to visit with family? Yes, says Dr. Strom. You should follow the same guidelines as everyone else, and assume that the vaccine has worked well after 2 weeks. You can visit with other people who have also been vaccinated. You should stay away from sick people, and avoid crowds of people you don't know, since you don't know if they've been vaccinated. As long as you don't fit one of the situations above (like being actively treated with something that suppresses the immune system), there is no data that says the vaccine won't work effectively for you.
  

All that is good news, but let me emphasize two more things.

First, one important factor in all of this, according to Dr. Evers, is "patient wishes." If, after all of this, you're still not comfortable, then don't take the vaccine. But in my opinion (as a non-expert), there is no evidence that taking the vaccine will be harmful to you just because you are a cancer patient. You may have some other health issues to consider, but cancer isn't one of them. The vaccine should be as safe and effective for you as for anyone else. "Patient wishes" involves your post-vaccine life, too. If you are not comfortable being around others, even those that you know have been vaccinated, then stay away from them. You have to consider your own comfort. We're all going to have to deal with "getting back to normal" in our own way.

Second, I'll end the way I began -- these are general guidelines about how the Covid vaccine affects lymphoma patients. Each of us should talk to our oncologist about our situation. Use what you learn in the webinar to start that converation -- "I heard in a LRF webinar that people who are on maintenance should deal with the vaccine by doing X. Is that true?" If you trust your oncoogist about other things, trust her answer on this question, too.

One last thing: I have had my first dose of the vaccine. I've been lucky enough that I was eligible, and that they were available, where I live. I know that's not true for everyone, and I hope that, wherever you live, you'll be able to get one soon, if you haven't gotten one yet. I'm glad I did it, because everything I have read says the chances that it will hep me are far greater than the chances that it could hurt me in some way. This webinar just confirmed that.

I hope this all helps, and I hope you have that conversation with your oncologist, and that, when it's available and appropriate, you get the vaccine. 

Stay well, everyone.

LRF Webinar on Covid-19 and Lymphoma

I'll be honest -- I've been actively avoiding the subject of Covid-19 in the blog. 

I have my reasons. 

The biggest one is that the science is changing pretty quickly, and I'm reluctant to write about something that could be wrong (or at least need an updating) in just a few weeks. I think, once we have some distance from al of this, we're going to look back on it and see just how remarkable it all was, in terms of science. The ability of researchers to identify information from data, and use that information to make recommendations, has been astounding. It took years -- decades, really -- to make progress in treating cancer. And as much as that has sped up in a few years, the pace of scientific knowledge about Covid has been incredible.

So I'm just trying to stay out of it. I can't keep up enough to be able to give you accurate information, so I don't give you any. And those of you who have emailed me wanting to talk about it, that's fine. You know I've been saying the same thing, encouraging you to talk to your doctor (because I'm not a doctor), and then telling you how I have been trying to handle things myself.

That's not very satisfying, I know. We'd al like to have answers to our questions. Especially about Covid vaccines.

So I'm happy to provide a resource to you.

The Lymphoma Research Foundation is hosting a webinar called "COVID-19 Vaccines: What the Lymphoma Community Needs to Know."

More details can be found here, including a link to register. 

I would consider the LRF one of the most credible sources of information around, so I would expect what they tell us will be as current as we can find. The presenters, Dr. Brian Strom (an epidemiologist) and Dr. Andrew Evens (a Lymphoma specialist) should provide a great combination for how infectious disease vaccinations affect cancer patients.

The time for the webinar (this Tuesday, April 13, at 12 noon EDT) is not the most convenient of times, and I'm sure that will prevent some people from listening in. That includes me -- I won't be able to make it. But I plan to register anyway, in case they send out a link to a recording later on. 

If any of you are able to make the webinar, feel free to send along an update. I'm sure many readers would like to hear the advice that's given.

Given the number of people who have contacted me to talk about vaccines, I think this is going to be a very popular, and very necessary, resource for lymphoma patients. 

In the meantime, stay safe, stay healthy, and take care of yourselves.

The Daffodils Are Blooming (and So Is Hope)

The daffodils are blooming around here.

I look forward to this every year.  Daffodils are symbols of hope, probably because they are one of the most colorful flowers to pop up in early spring. I love to see the bright yellow against the brown dirt, still-brown grass, and brown foliage of the plants all around them.

My favorite daffodils are the ones that are planted in my blackberry patch.

 I've written about this before, in the blog and in an article on The Mighty. My blackberry patch was an accident. A squirrel must have dropped a blackberry, and the canes grew up into a thorny patch. Before I knew they were blackberries, I tried to get rid of the canes. Now I look forward to them every year -- making some blackberry jam, and sharing our bounty with the birds. 

But those canes are very thorny. Picking the blackberries usually means a lot of scratches on my arms. So when the daffodils come up, it's a beautiful sight. The blackberry canes are still brown and without leaves. And the bright yellow daffodil shines right through.

As I say in the article (you should really click the link and read it -- of all of the stuff I've ever written, it's one of my most favorite), daffodils are about hope, and hope growing up around all of those thorns is as nice a symbol as I can think of. Even in the middle of all of that bad stuff, there's still beauty and hope. Sometimes you don't even have to look that hard to find it. It just shines through.

So my suggestion for you today: look for the hope and beauty in your life. Maybe it's easier to find than you think.

(And as a thank you for reading, here's a bonus picture of Katara smelling the daffodils. Don't worry -- she's not among the thorns. She is safely behind them.)

Two Treatment Approvals for Follicular Lymphoma (Outside the U.S.)

As you probably figured out, I like to share news about good things happening in clinical trials for Follicular Lymphoma treatments. And I really like to share news about approvals for new treatments.

And I am very aware that the news I share is almost always about FDA approvals -- those approved for use in the United States. Which makes sense, since that's where I'm from. 

But I also know that many of you live outside the U.S. So FDA approvals don't necessarily mean much to you (though I get the sense, anyway, that FDA approvals give you some hope, if it means a new treatment might be available to you at some point in the near future).

I try to keep an eye out for any non-U.S. approvals, and I'm happy to be able to share a couple of them with here.

The first is from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP gave a positive recommendation for Duvelisib (also known as Copiktra). Duvelisib is a PI3K inhibitor (Phosphoinositide 3-kinase inhibitor). It works like other inhibitors work) by stopping something from happening, in this case, some signals that cancer cells receive that allow them to live and grow and not die. There are a few PI3K inhibitors out there. Duvelisib is different because it works on two different isoforms of PI3K, the delta and gamma isoforms.It is taken as a pill, twice every day, which should make it easy to take (easier than sitting in a treatment room with an intravenous drip, anyway). 

The CHMP makes a recommendation to the EMA, which then gives the final approval for use throughout the European Union. I don't known enough about the EMA to know how long that process will take, but from what I can tell, a CHMP recommendation is pretty much a guarantee that the treatment will be approved. So that means (hopefully soon) our friends in Europe who have had at lest two other treatments will now have another option.

The other recent approval is for a CAR-T treatment in Japan. The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Breyanzi (also known as Liso-cel) for aggressive Diffuse Large B Cell Lymphoma, and for Relapsed/Refractory Follicular Lymphoma. Breyanzi was approved by the FDA in February. 

The price for the treatment has not yet been set, so I assume it is not available immediately. But I also assume that will happen very soon.

As much as I enjoy giving news from the FDA, it's even nicer when I come across news for those of you in other countries as well. I get to celebrate all over again.

And it's all a great reminder that there are great advances happening in the world of Lymphoma. Lots of reasons to be hopeful.

Thanks for Reading

 Just a quick comment about something that's been on my mind for the last few days.

A little more than a week ago, I posted the news that my wife and I have a new puppy. I appreciate all of those who said she was really cute. (I agree -- she is.)

As I was looking at the comments and trying to find time to respond while my dog was taking a nap, I couldn't help but notice that the commenters were from California and Virginia, on both sides of the U.S., plus Ireland and Brazil. And while that conversation was going on, I was having email exchanges with readers from Italy and Canada.

I really love how far and wide the blog has traveled. It was never really intended to be something like that. I started it, as some of you know, as a way to let family and friends know what was happening with my diagnosis and (what I assumed would be upcoming) treatment. At some point, I got a comment from someone from Florida (about 1200 miles away). A few months later, another comments from a reader in Scotland. And since then, more readers from all over the world.

I can't tell you how happy that makes me. 

One of the great things about being a cancer advocate is hearing from people that I've said or done something that has helped them. To know that I've helped so many people, from so many parts of the world, is really amazing. 

And that says something about how connected we are. Not just as cancer patients, or Follicular Lymphoma patients and survivors and caregivers, but just as people. We all have some of the same needs. To find information that we didn't have before. To connect with others who have shared the same experiences. To know someone else is out there. 

I'm happy to be the person who can give the information and be the one whose experiences are being shared. 

But you all should know that you do the same thing for me. 

I've always said that I'd write the blog even if I didn't know anyone was reading it. It does me good to read and write and stay informed, and to work through some things that are on my mind.

But it's even better to hear back from people and know that someone is out there.

So thank you again for reading. All of you, wherever you are. 

And as always, feel free to comment, or to email me (address is in the profile). I love to hear your stories, and I'm happy to help whenever I can.

Stay well.

Bob

Glofitamab: Bispecific for Follicular Lymphoma

Some exciting news from the world of Lymphoma this week. A bispecific had some excellent results in a phase 1 clinical trial. 

The results were published in The Journal of Clinical Oncology article called "Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial." 

Some background first. A bispecific is a treatment that connects to two different cells (which is where the "bi" comes from in the name). Think of Rituxan, the monoclonal antibody. It attaches itself to the CD20 protein on a B cell (the kind of cell that turns cancerous in Follicular Lymphoma). Very effective for lots of people. Now imagine something like that, but double-ended. One side can find a protein on a cancer cell and stick to it. But the other side can also find a cell and stick to it. In this case, a T cell, the kind of immune cell that kills invaders. The bispecific acts as a way to bring the cancer cell, and its worst enemy, right next to each other. A very cool idea.

And a very effective one, apparently. There are a few different bispecifics being tested  in trials for blood cancers. This one, called Glofitamab, works as I just described. That "-mab" on the end shows that it is a Monolonal Antibody, and it connects to the same protein as Rituxan does (CD20). But it also connects on the other end to the protein CD3, found on T cells. 

T cells can be very powerful, as long as they can figure out that cancer cells shouldn't be ignored. (The "T" in CAR-T stands for "T cell.")

 The study described in the article is a phase 1 trial, meaning its main focus was on "dose escalation" -- figuring out how much of the treatment to give to be most effective while staying safe. There were patients with lots of different blood cancers in the trial, mostly aggressive (like DLBCL and transformed FL), but with some indolent FL as well.

In an interview with the lead researcher, he pointed out that the treatment seemed to be even more effective as they increased the dose, while keeping side effects manageable. Patients in the trial were first given Obinutuzumab to cut down on the number of cancer cells, and then given the Glofitamab.

The Overall Response Rate was 53.8%, including Complete Responses in 36.8%. Different types of lymphoma had different response rates. Transformed Follicular Lymphoma's ORR was 41.4%, but indolent FL had a response rate of 70.5%. That's excellent.

Of course, there were side effects. Cytokine Release Syndrome was a problem for about half of the patients, with severe CRS in a small number (3.5%). Five patients had to withdraw because of serious side effects. Other side effects included nerve issues and low blood counts, which are common in blood cancer treatments.

The lead researcher is optimistic that this treatment could eventually be as effective as CAR-T, though less expensive, since it is "off the shelf," while CAR-T needs to be manufactured specially for each individual patient.

I like optimism, but a phase 1 trial is a long way away from the doctor's treatment room. I hope he's right. We'll have to wait and see.

The phase 2 trial will use the dose that was most effective in the phase 1 trial. There may be separate trials for the different types of lymphoma being studied.

I have a feeling this bispecific, and some others, will be a big topic of conversation at the ASCO conference in a few months. Which I'm excited about, since it will be online ad I'll be able to attend again this year!