Shorter Obinutuzumab Infusions for FL (Europe)

Good news for those of you in Europe -- The EMA (European Medicines Agency, the equivalent of the FDA in the US) has approved a shorter infusion time for Obinutuzumab. Now, instead of taking 3 to 4 hours for an infusion, it should be done in about 90 minutes.

The change comes from the results of the GAZELLE study, which involves patients with Follicular Lymphoma, some who have not had a treatment yet. The purpose of the study was to find out if the Obinutuzumab infusion could be shortened, and was given as part of a treatment with chemotherapy. 

Patients were given the first round as usual, with the longer time. Those patients who did not have a serious reaction were then given the shorter version for the other rounds of treatment. About 62% of the patients in the study had an infusion-related reaction, but only about 6% has a grade 3 (serious) reaction, and none had a grade 4 or 5 (most serious). 

The faster infusion was based on infusion-related side effects, not side effects that came later (and 99% of patients in the study had some kind of side effect -- it's to be expected).

Obinutuzumab is given as an alternative to Rituxan. It's very similar -- a monoclonal antibody that targets the protein CD20. It is made a little bit differently, using human cells rather the mouse cells used in Rituxan. It has been approved in FL in combination with Bendamustine, followed by Obinutuzumab maintenance. It is slightly more effective that Rituxan, with slightly worse side effects.

I've never had Obinutuzumab, but I know what it's like to sit in a chair in the treatment room for 6 hours to get Rituxan. I had an allergic reaction to my first dose (which is fairly common), so the rest of my doses had to be slowed down. It would have been pretty great to have it all cut down to 90 minutes.

And, of course, that would have other benefits, too, besides the important Quality of Life changes that come with not having to spend all day in a chair. Shorter infusion times should mean a lower cost, which is good for everyone. It also could mean more safety in a more general way -- with a pandemic still going on, it would be great for someone who is immunocompromised to be able to spend less time in a hospital or doctor's office, or anywhere else with lots of people around. And less time in the chair means more space open for other patients.

The approval covers Europe, and starts immediately. No word on when the maker of Obinutuzumab plans to apply for FDA approval as well. But it's good news for a lot of you from  Europe.

Lymphoma Research Foundation Events

I have advertised a few events from the Lymphoma Research Foundation over the last year or so. I think the LRF does a good job of getting information to patients in ways they we can understand.

The LRF has two events coming up that might be of interest to you all.

The first is LRF's North American Educational Forum on Lymphoma. It's coming up very soon -- October 15th to the 17th. You can register for it here.

The forum has many presentations, including Lymphoma Overview for Newly Diagnosed Patients and Caregivers (Jacob Soumerai, MD, Massachusetts General Hospital), Lymphoma Survivorship (Priyanka Pophali, MD, University of Wisconsin) and Relapsed/Refractory – How to Cope When your Lymphoma Returns? (Jennifer Amengual, MD, Columbia University Medical Center). There are others focused on CAR-T, nutrition, and Covid-19. And then there are special sessions on individual Lymphoma types, including Follicular Lymphoma. 

Registration is required, though the event is free. If you're interested, do it soon.

The second LRF event is one of their "Ask the Doctor" events. The North American Forum is probably going to be very large with hundreds of patients and caregivers. "Ask the Doctor" is usually a little smaller and more intimate. The idea is that patients can ask questions of the doctor, and with fewer of them, there's a better chance of getting one answered.

The Ask the Doctor event that is coming up next is with Dr. Caron Jacobson of Dane Farber, on October 26. But there are a few others during the fall, too, including one conducted in Spanish on November 2, if that is your preferred language. The sign-up page for all of the Ask the Doctor events is here.

Knowledge is good. It's nice to have the opportunity to hear form experts, and even better to have the chance to ask questions and get answers.

Trial for a New CAR-T Has Been Paused

The phase 1 clinical trial for a new CAR-T treatment has been paused (not cancelled) while the FDA tries to figure out why one patient is having some problems.

Quick review -- CAR-T involves removing a patient's T cells (a type of immune cell), changing them in a laboratory so they can recognize cancer cells as something to be eliminated, and then putting them back into the patient. Ideally, they do their job of killing off the cancer cells, and the stay in the body (like any other T cell) until they recognize any return of the cancer cells, and take care of them.

This clinical trial involves a different kind of CAR-T, an "off the shelf" version called ALLO-501A. In other words, instead of using the patient's own T cells, ALLO-501A uses the same T cells for every patient. If it works, it should be much easier and less expensive -- there is no lab involved in the process of removing and changing the T cells.

The trial is small (which is usually the case for phase 1 trials), and involves patients with Diffuse Large B Cell Lymphoma and transformed Follicular Lymphoma. (These were the same patient populations that were in trials that led to the first round of CAR-T treatments for lymphoma patients.)

One of the patients in the trial has bone marrow biopsy after the treatment to look into low blood counts, and the cells were found to have a chromosomal abnormality. Chromosomal changes in cells can lead to a whole bunch of issues, including other cancers. The researchers are pausing to do some investigating, to figure out if the CAR-T treatment caused the abnormality, and if the abnormality might lead to more problems for the patient (and for future patients).

As the article linked above points out, the patient had a partial response to the CAR-T treatment, and after finding the issue from the bone marrow biopsy, was given an allo stem cell transplant, something that happens with certain patients after other CAR-T treatments, too. 

Aside from the issue with this patient, the data fro the trial has been positive, and seemed like the effectiveness was good enough to justify a larger phase 2 trial. However, trials are about both effectiveness and safety, and the pause makes that clear. One patient's safety is important.

"Off the shelf" CAR-T will be a huge benefit to lymphoma patients, if they are shown to be as safe and effective as other treatments. I hope the patient with the issue is doing OK, and I hope researchers can determine that the treatment is safe enough to continue.

The company that makes the treatment is holding a press conference later today (Oct 8). If anything important comes out of it (more than just repeating what we know already), I'll update.

What Survival Statistics Mean

I used to write a column for Lymphoma News Today a few years ago. You can still find it there, under "columns." It's the one with "hope" in the title.

And even though I haven't written for them for a while, people still read them and I still get comments on them. I know this because the system at that website for dealing with comments is to have author approval. So whenever someone writes a comment on my column, I get an email asking me if I want to approve the comment (otherwise, it won't get seen by anyone), and if I want to respond. It's a good way to make sure there isn't any spam or other useless comments on the site. And it means that even though I haven't written for them in more than two years, I still have access to the site.

Without question, the column that keeps getting the most readers, and the most comments, is the one called "We Need to Talk about Survival Statistics." Someone left a comment for me this weekend, which made me think about it some more. Two things I noticed when I looked at it again -- it was published almost three years ago (on October 5, 2018), and it has 71 reviews, with 4.7 out of 5 stars. (My column, "I Find Hope in Cancer-Themed Humor" has 0 stars. It's dangerous for a writer to read reviews. I'm not even going to link to that one. Find it on your own.)

I'm really pleased with the column because I think it gives what is probably the most important message I try to get out -- learning as much about your cancer as possible is a way to become empowered. I'm not going to tell anyone how to be a cancer patient. We all need to deal with this in the way that makes most sense to us, and I know people (especially some with Follicular Lymphoma) who would rather just not think about it all. 

And that's fine. But I also know that the thoughts are going to creep in anyway, whether we want them to or not, and I think it's better to have good answers to nagging questions.

So when we ask things like "How much time do I have?" or "What does it mean if I read that the survival rate is 8 to 10 years?" I know where my mind went when I was diagnosed and I read that. I think it's important for people to have an answer.

I think it's worth reading the column again. For those of you who are new to this, it will help explain what "Overall Survival Rate" means. And for those of you have been dealing with FL for a while, it's worth being reminded about.

And for what it's worth, the survival rate for FL is close to 20 years -- double what it was when I was first diagnosed in 2008. That's good news for everyone, but it also doesn't mean that we're not all individuals, and statistics tell a story about large groups, not single people. 

I like to remind everyone about that every few years. So this is your reminder. Enjoy the column.

Use of Tazemetostat in R/R FL

Cancer Network has a new video series on Follicular Lymphoma. You all know I like these kinds of things, since they usually involve a Lymphoma expert giving their take on what is happening in the world of Lymphoma research. I enjoy watching an expert talk about what they think is exciting.

This series features Dr. Connie Batlevi from Memorial Sloan Kettering Cancer Center in New York. (Dr. Batlevi is a "double doctor" -- she has an MD and a PhD, which I always find impressive as heck. Not only smart, but willing to stick with two programs.)

What I found most interesting about the series is video #3, "Use of Tazemetostat in R/R FL." That link will take you to the video series, which includes transcripts, in case anyone wants to read and/or translate the text.

When Tazemetostat was approved for Relapsed/Refractory Follicular Lymphoma last year, I was kind of unimpressed with the numbers, and a little unsure of why everyone was so excited about it. It seemed like a relatively small number of patients would benefit from it. And the company that makes Tazemetostat was fairly aggressive in marketing it; I was seeing ads for it all over the place.

(And before I go on, this is a good time to remind everyone that I am not a doctor or a cancer researcher. I'm a patient who reads a lot and tries to stay informed. So when I say I was "unimpressed with the numbers," take that for what it's worth. An informed opinion, but not an expert opinion.)

The video does a good job of explaining why Tazemetostat is something to be excited about.

Tazemetostat is an EZH2 inhibitor. We know that inhibitors work by inhibiting things -- stopping something from doing what it wants to do. In this case, it stops EZH2, an enzyme that is involved with winding and unwinding DNA, and helping cancerous B cells to grow. So inhibiting, or stopping EZH2 will help stop FL cells from growing. (I think Dr. Batlevi does a very good job of explaining this.)

Not every FL patient has mutated EZH2, and Tazemetostat works best on the 25% or so of FL patients that do have this mutation -- about 70% of those patients had a response, and about 20% of those had a durable response, one that lasted more than 18 months. About 35% of patients with a "wild type" EZH2 had a response, with about 20% of those having the same 18 month response.

So why the excitement? Two reasons.

First, as Dr. Betlavi explains, Tazemetostat is one of the first truly targeted treatments for FL. There needs to be some genetic testing to figure out if the patient has mutated EZH2. Having a treatment that uses this kind of approach successfully "opens doors in terms of how we can use genetic profiling and personalized medicine to do more treatments in lymphoma," as she says. That happens a lot -- someone shows that a particular approach works, and other researchers build on that approach in new ways. 

The other important thing is that Tazemetostat has a good safety profile -- there aren't many side effects, and those that exist aren't too severe. That makes it a good candidate for combination with other treatments. If two treatments kill cancer cells in different ways, and their combined side effects aren't too harsh, then we may have a treatment combination that is effective and helps maintain quality of life -- something very important in a cancer like FL that may involve many treatments over many years.

So it's a good video. I like video series like this because they usually reinforce what I know about FL, but this one was great because it taught me some new things.

And since I'm a non-cancer professional who shares my opinions about cancer, that's good for all of us. 

 

My Many Doctors

I had my annual physical exam this morning. Everything looks good. 

To be clear, this is the exam I do every year with my "regular" doctor, the GP (general practitioner), not my oncologist. The point of the exam is to make sure everything is working properly, and my mental and physical health are OK. If something doesn't seem right, or if I have complaints, then this appointment is the time where I'd be referred to a specialist. 

The doctor asked the usual questions at first, about my smoking and drinking habits, if I'm exercising enough, how work is going, any new sources of stress, etc. All good there. 

The she asked, "Do you have any questions for me?"

I laughed. "No. I have so many other doctors that I see, that I get all of my questions answered by them."

And it's true. As she was doing the physical exam, taking my blood pressure, and all that, I tried counting the number of doctors that I see on a regular basis.

There's the oncologist, my cancer doctor. I see him every six months or so. I have an appointment coming up next month.

I also see a dermatologist, my skin doctor. The oncologist encouraged me to see her at least once a year, though it seems like a see her twice a year to check up on something that came up when I see her once a year.

Then there's the cardiologist, my heart doctor. My heart is actually in pretty good shape. I had a stress test a few months ago, and the report came back as "excellent." But I do have an "electrical problem," with a strange fast heartbeat that comes around every few months. Plus some high blood pressure.

The cardiologist sent me to a pulmonologist/sleep specialist. There's a not in my online medical records that I'm supposed to make a follow-up appointment with her soon.

Which reminds me -- I'm also due for a 10 year colonoscopy with my gastroenterologist. I don't see him as often as I used to, which is nice. But I do see the Otalaryngologist for my ears a couple of time a year. Too much Black Sabbath at high volume when I was young.

But it all got me thinking about how amazing the body is. Amazing enough that we need a whole bunch of people whose focus is on just one thing.We are such complex creatures. It's kind if fascinating.

At the same time, it's easy for doctors to see us as individual body parts, and not as one whole, amazing, complex creature. I don't know how much one of my health conditions affects the others, but it's certainly possible. Rituxan can cause heart rhythm issues -- did my cancer treatment affect my heart? Or was it sleep problems that cause the heart issue? And that medication the gastro doctor had me on for years -- will I end up with the kidney problems, or the dementia, or the bone loss, that I'm at higher risk of by taking the medication for so long?

And that's the problem. To one doctor, I might be just lymph nodes. To another, I'm just ears. To another, a weirdly beating heart. 

That's the danger, and I know people in a similar situation (seeing lots of different specialists) who don't ever seem to have their many doctors communicate with one another. I'm lucky that I do have a few doctors who at least who see me as more of a whole -- making sure I talk to someone else about potential problems.

For me, as someone who sees lots of doctors (and nurses, physician's assistants, etc.) to just kind of let it all wash over me. Another day, another appointment, something to get over with and move on. 

And it's also easy to think about everything that's wrong with me, and wish that I had a better heart, smaller lymph nodes, a shoulder that didn't act up if I sleep the wrong way.

It's nice to stop and marvel, for just a minute, at how amazing the human body is, in all its complexity. And to think about how much we don't know about it yet. And about how wonderful it will be when we learn those new things, and use that knowledge to make us feel better. 

World Lymphoma Awareness Day

 Today is World Lymphoma Awareness Day.

The World Lymphoma Coalition, which is made up of 80 lymphoma-related organizations in over 50 countries, has chosen a theme for this year: "We Can't Wait." They are looking to highlight the ways that the Covid-19 pandemic has affected lymphoma patients around the world.

And there have certainly been many ways we have been affected. A lot of us have compromised immune systems, which make us more vulnerable to the disease. Others have tried a vaccine, but have not gotten a benefit from it, because of their "imperfect" immune systems. All of us are affected in the long-term by the slowing down of research, when hospitals and university labs were closed last year, and by research money that was shifted to pandemic-related causes.

We can't let people forget about us. We can't wait for things to get back to "normal," whatever that was, and whatever is now is.

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I almost always say the same thing on World Lymphoma Awareness Day: personally, I don't need the reminder. I'm aware of my lymphoma every day. I think about it and read about and write about. Every day.

But it's other people who need to be made aware.

Yesterday, we got the news that the comedian Norm MacDonald died. I liked his comedy. I saw one obituary that described him as a "patient" comic. He would spend a full five minutes on a story that had a goofy punchline, the kind of thing my kids would tell me when they were 8 years old. But he could also tell jokes that were incredibly caustic and biting and adult. Someone once described him to me as saying he really liked to make people "uncomfortable" with his comedy. He was unpredictable that way. that's partly why I liked listening to him. I like to laugh at uncomfortable things. It's helped me deal with cancer.

Yesterday, I heard a replay of an interview he did once, where he was critical of people (particularly celebrities) who publicized their illnesses. He thought talking about it was just a way of getting sympathy. The braver choice, he thought, was to not talk about it or burden others with it. "I might have a specific ailment," he said. "Maybe I do. You don't know. But I wouldn't talk about it."

Of course, he did a specific ailment. The obituaries and tributes mention that he died of cancer (I don't know what type). A friend of his confirmed that he had been keeping his diagnosis private for about 10 years.

Now, given that I write a lot about my own cancer, I obviously disagree with Norm MacDonald on this. I'm more of a "shout it from the roof tops" kind of person when it comes to cancer.

And let me be clear: I am not in any way criticizing Norm MacDonald for wanting to keep it to himself. I've known as many roof-top-shouters as I have people who wanted to keep their diagnoses private. And they keep things private for many, many reasons. I would never tell another cancer patient that they were somehow "doing it wrong." We all need to find the best way to deal with our diagnosis -- our own best way. Every cancer patient has had one common experience: we've heard the words "You have cancer." That's enough to unite us. What happens after that is whatever makes sense to each of us individually.

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And that's why "awareness" matters so much. I shout so Norm MacDonald, and others like him, didn't have to.

Someone has to tell the stories, because as individual as our stories are, there's always something in them that someone else -- maybe just one person -- can connect to. One small detail to make another cancer patient realize that they aren't alone in feeling a certain way.

Someone has to ride the bike or run the marathon or sell the lemonade, or whatever else gets done to raise money for research.

Someone has to share the meme, or take the quiz, or post the story on social media. 

Those of us who are able to do those things need to do them, so other people don't have to. So they can deal with things in the way that makes most sense to them, that helps and supports them in their own best way.

That's what "awareness" is really about. Not making yourself aware, but using yourself to make it easier for others, even in small ways.

As I always say, there's lots to be hopeful about in the world of lymphoma. Do what you can to let others know that, too.