HealtheVoices

I spent today participating in a lot of the HealtheVoices Live! conference.

HealtheVoices (that's Health-e-voices, as in electronic voices, but also healthy voices) is usually an in-person conference, a gathering of about 150 online health advocates. People have to apply (it's a popular conference), and I was lucky enough to be chosen to attend in 2017 and 2018, and then again for this year. It would have been in Dallas this weekend, but it was cancelled.

And instead, it was replaced with Super HealtheVoices Live!, online workshops and opportunities to interact with other advocates. Not quite the same thing as being in a room with people, but still nice to be able to "see" some other advocates that I met in the past.

I learned some new things, and some important lessons reinforced. There are some really amazing health advocates out there, helping people with all kinds of health conditions.

But it also kind of reinforced some of the isolation that our world situation has created. As I've said, I'm home with my wife and kids, and that's been nice. We're all keeping busy, staying out of each other's way, but also coming together a few times during the day. We're managing to keep a healthy balance.

Still, it's hard to be isolated from others.

So I have an idea.

One of the sessions I "attended" was about ways to connect with communities. Obviously, I do that through my writing, here on the blog and elsewhere.

What would you all think of trying some other way to connect? What would you think about trying to set up some kind of video conference, so readers who are interested could see one another's faces (including mine) and hear each other's voices, and maybe share some stories? I don't really have an agenda in mind, just thinking of ways to connect. There would lots of details to work out, respecting privacy, finding a time that's good for lots of people, choosing the right platform. But maybe some of you are looking for a way to connect?

Let me know what you think. Write in the comments or send me an email.

Keep staying healthy and safe, everyone.

Free Lymphoma Workshop

The Lymphoma Research Foundation is holding a free workshop for Lymphoma patients next Saturday, April 25, from 9:00am to 12:30pm (Eastern Standard Time).

(This is a workshop that would have been held in person, and was meant for patients in the Northeastern United States. That's why the time is early -- maybe too early for people in the Western U.S., but at a convenient time for folks in Europe.)

I got an email about this, probably because I attended a local LRF workshop a few months ago.

The lineup looks pretty good. Here's the LRF's description of the day:

LRF’s free regional virtual lymphoma workshops are interactive programs led by leading lymphoma experts who discuss lymphoma, treatment options, clinical trials and promising innovative research. These workshops can be listened to live on the telephone or via web streaming.
Program
•    Lymphoma Overview – Pierluigi Porcu, MD, Jefferson University Hospitals
•    Promising New Therapies – Andrew Evens, DO, Rutgers Cancer Institute of New Jersey
•    Clinical Trials – Carla Casulo, MD, University of Rochester
•    Lymphoma Survivorship– Sharyn Kurtz, PA-C, Dana-Farber Cancer Institute

This isn't specific to Follicular Lymphoma, but my guess is that they will have some information that will be useful to FL patients.

I recognize the names of a couple of the speakers; they've done some videos for oncology websites, and they do a good job of explaining things in clear language. I'm sure all four speakers will do an excellent job.

If you're interested, you can find a little more information, and a link to sign up, at
https://beacon360.content.online/xbcs/S1791/catalog/product.xhtml?eid=19477

Alas, I won't be able to attend. I was supposed to be in Dallas, Texas next weekend for the HealthEVoices conference for online health advocates. We won't be able to meet in person this year, of course, but I'll be in online workshops for most of the day on Saturday.

If any of you does the LRF workshop on Saturday, let me know in the comments. I'll be curious about how it goes.

Rituxan Biosimilar Approved in Europe

Earlier this month, the European Commission gave its approval for Ruxience, a biosimilar for Rituxan (Rituximab, MabThera -- all the same treatment). Ruxience was approved for use the United States last year.

As you might remember, a biosimilar is sort of like a generic drug -- a copy of a treatment that is as effective and safe as the original treatment, but maybe cheaper to use.

Biosimilars are a little different from generic drugs, because they are made from somethng that is or was alive ("bio" means "life."). That makes things trickier than a generic drug, which is made from chemicals. Making a generic drug is like following the recipe for a cake. Making a biosimilar is like trying to figure out how to copy the eggs.  

But, like generic drugs, biosimilars should be cheaper than the original. When someone develops a treatment (like Rituxan), they generally have exclusive rights to that "recipe" for a certain number of years. This lets them make back all of the money they spent on developing the treatment, testing it, and marketing it. After that time period, other companies are allowed to try to copy it. They must then test the copy in clinical trials to make sure it really is a copy -- as safe and effective as the original. But because they didn't spend all of that money developing it, they can sell the biosimilar to patients for less money (at least in theory).

Rituxan has been a very successful treatment, not just for Lymphoma, but also for Multiple Sclerosis and Rheumatoid Arthritis.

Ruxience is the second biosimilar for Rituxan/MabThera approved by the FDA (the first is called Truxima).  Both have been approved for use in Europe now, too.

Interestingly, the the application for two other Rituxan/MabThera biosimilars were withdrawn recently. Not sure about the first one, but the second one wasn't able to provide the data necessary to show it would be as safe and effective as the original.

The good news, though, is that many people have access to treatments that may be as effective and safe as Rituxan/MabThera, which we know has been a huge hep for those of us with Follicular Lymphoma.

Blessings

Today is Easter, and a Happy Easter to those who celebrate.

Easter, being a spring holiday in the U.S., is tied up for many people with the things that make spring wonderful: new beginnings, hopefulness, and a kind of cleansing of the mind and spirit. Even if people don't celebrate the religious aspects of Easter, many of them see the day as a reason to celebrate life.

That's a little harder to do this year, given the situation that so many of us find ourselves in.

I'm coping by counting my blessings. I and my family have remained healthy. I live in a town and a neighborhood full of caring people, who encourage one another and make sure to stay away from one another. (Someone from the neighborhood dressed as the Easter Bunny yesterday, and drove through the neighborhood so kids could see him/her, which was a very nice thing to do.)

My kids are home, and we're finding ways to stay busy, stay out of each other's way, and still stay supportive. I am able to work from home, which is a blessing in many ways, despite its difficulties.

The daffodils are at their peak, and when my wife and I take our early morning walks, we see them throughout the neighborhood, waking up and turning toward the sun.

Yesterday, we saw that the the small asparagus patch we planted last summer has come back to life, with a few purple stalks poking through the soil. Hard to describe how much joy that brought us. I prefer daffodils as a sign of hope, but asparagus works, too.

I can't say everything has been amazing. I wish I could tell you that my mental and emotional health has been perfect, but that's just not true. I almost always end up with bad allergies this time of year, with a trip to the doctor's office to tend to my bronchitis. Given the nature of Covid-19, every cough and wheeze, itchy eye rub, and strange back ache (from bending over my work computer) sends me into a small panic. And even if I convince myself that it's just allergies, I worry about the effect of my tired lungs.

Still, I remain hopeful, and I look for signs of hope all around me.

This week, Blood-Cancer.com published a piece I wrote called "Staying Hopeful vs. Staying Positive." It describes my attitude. I don't like the idea of staying positive, even though I'm a pretty positive person. I think staying positive sometimes denies the bad things and looks only at the good. I'd rather stay hopeful, because hope recognizes that things might be bad now, but there's a chance they'll get better.

So that's where I am. I know there's bad stuff. I can't ignore it. But I can focus on the good things, and wish for more of them.

And I hope that's where all of you are now -- staying healthy in the middle of a difficult time, looking around you to find things to be hopeful about. Maybe some daffodils. Maybe some asparagus. Maybe your faith. Maybe just the start of a new day.

Take care everyone. Stay hopeful.

Zevalin Update

Interesting research on Zevalin, the RadioImmunoTherapy (or RIT) treatment. "Real world" data shows that it works well, with good response and survival numbers. The research was presented at the 2020 American Society of Clinical Oncology and Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium in February.

The "real world" data means that this research was not part of a clinical trial. Instead, the researchers looked at the records of 171 Non-Hodgkin's Lymphoma patients (107 of them with Follicular Lymphoma) who had been given Zevalin between 2005 and 2017.

As a reminder: Zevalin is a kind of RIT. Basically, RIT is a type of treatment that target cancer cells, the way something like Rituxan does, but grabbing on to a protein on the surface of the cancer cell. But RIT also adds a little bit of radiation to that Rituxan, so the radiation can be delivered right to the cell. Traditional radiation doesn't work as well on lymphoma because the blood cells are always moving, making it hard to hit them with a beam. RIT is a way to deliver the radiation right to the cell. 

In this study, 73 patients achieved a Complete Response from the Zevalin, and 23 had a partial response, for a 70% Overall Response. The median Progression Free Survival (PFS) was 31 months. Not bad for a group that had a median of two prior chemotherapies.

Zevalin has been around for a long time, and has been very effective for a lot of patients. Data presented at the ASH conference last December showed how successful Zevalin was as a long-term treatment. In a study of 137 patients with Follicular Lymphoma who had a Zevalin treatment, patients who had it as their first treatment had a 100% Overall Response Rate, and a 93% Complete Response Rate. For patients who had Zevalin as a second or later treatment, the OR was 93%, and the CR was 73%.

So why isn't RIT used more often?

Well, in the United States, there are particular rules about who is allowed to administer RIT. The amount of training required means that only a small number of Radiation specialists will qualify 9or want to). If oncologists and hematologists, the doctors we typically go to, are not able to administer it, then they likely will look to other treatments when figuring out what to recommend. As FL patients, we are fortunate to have lots of  choices, and most oncologists will go with those choices. And because it's not used often, there's a chance that some oncologists don't fully understand it, or misunderstand the risks involved. Lymphomation.org has a very good section on RadioImmunoTherapy, including some great reading on why it is not used as much as it should be.)

There is an RIT treatment that has been Fast-Tracked by the FDA, called Betalutin. It is still in trials, though if the company that makes it is still excited about it being approved, then I have to think they also have a strategy for getting it understood and recommended by oncologists. I sure hope so.

I've known a few people who had RIT and continue to have very good long-term results, so I've been fascinated with it for a long time. Perhaps the day will come soon when we see a change in attitude toward it, and more use of it.

Accelerated Approval for ME-401

I'm certainly paying attention to COVID-19 (and still working through my own anxieties about it), but I'm not sure I have a whole lot more to say about it than I've already said. Thinking and reading about kind of puts me in a holding pattern. I'm focusing on the present, trying to take things day by day.

But, at the same time, I need to look ahead. Hope is all about looking ahead, isn't it? Recognizing that things aren't necessarily great right now, and wishing that the future will be better?

With that in mind, it's time to get back to some Follicular Lymphoma news.

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

The FDA has designated ME-401 for Fast Track consideration. I've seen a few notices for this online, but not really any details beyond what you'll see here.

The application is for patients with Relapsed or Refractory Follicular Lymphoma (their last treatment stopped working, or didn't work at all) who have received at least 2 prior systemic therapies (chemo, immunotherapy, etc.)

Fast Track designation by the FDA means the treatment is "serious" (likely to result in death if not treated), and the treatments "meets an unmet need" (it is shown to either be more effective or safer than what is available).  Fast Tracking might mean more frequent communication between the FDA and the company making the treatment, so that approval (if it comes) can come sooner.

There's no guarantee, of course, that approval will come at all.

ME-401 is a PI3K, or Phosphoinositide 3-Kinase, inhibitor. As you know from reading, inhibitors work by inhibiting, or stopping, processes that go on in a cell that make it cancerous. Inhibiting Phosphoinositide 3-Kinase means the treatment will stop one of the PI3K enzymes that tell cells to grow. When cells grow without knowing when to stop, they become cancer cells. PI3K inhibitors tell them to stop growing.

ME-401 is, in particular, a PI3K Delta inhibitor. There are four different PI3K enyzmes (alpha, beta, gamma, and delta), and a few different inhibitors that try to target one or more of those different enzymes. They are kind of a common treatment in the Follicular Lymphoma pipeline these days, with some familiar names -- Idelalisib, Duvelisib, and Copanlisib.

The Fast Track designation seems to be based on the results of a phase 1b trial, announced last fall. It's a small trial, with 55 Follicular Lymphoma patients (as of last fall, anyway). But the results were very promising, with 78% of patients in the trial responding. That seems more effective than other PI3K inhibitors.

It will be interesting to see hoe the FDA responds. A phase 1b trial is pretty small, so they may ask for more updated results (it has moved on to a phase II trial now, with 120 participants). I haven't seen a breakdown of how many of the responses were Complete and how many were Partial, which makes me think there were a lot more Partial Responses than Complete Responses. So maybe this ends up being one of those treatments that is taken every day for a year or two to help hold off the need for additional, more aggressive treatment? Certainly patients who would be interested in that.

The good news is, there is another treatment being considered for us. Not the best news, but good news. We'll wait for additional trial results, and more from the FDA, before we start getting especially positive about it.

But we can be hopeful.

COVID-19: Managing Anxiety and Fear

I hope everyone is doing well during this difficult time.

My family and I are doing OK.  We're keeping busy, which is good. My wife and I are able to work from home, which is a blessing. My two younger kids, both college students, are taking all of their classes online. They have plenty of work to do -- also a blessing. My oldest, who finished college a few months ago, has moved back in with us. He's been working a job that cannot be done at home. I'm glad they've given him and his colleagues the time to stay at home (with a little bit of pay), but he's the least busy of us. He is taking a course online, which is good, and he has created a Dungeons and Dragons campaign for the family, so as Dungeon Master, he has a lot of work to do.

(If you're not a D & D fan, and you don't care what it is, that's fine. If you're curious, you can find out the basics here. If you are a fan, know that I am a Dragonborn Rogue, and not a good one, since I rolled a natural 1 the first time I tried to use my Thieve's Tools and almost got us all killed by palace guards. Also, my best friend is a Gnome Barbarian, and a really bad influence.)

The point is, we're managing to stay home and stay safe.

Which isn't to say my mental and emotional health is completely good.

My wife and I have been trying to take a walk every day, which is good for us, physically. We live in a neighborhood of friendly and kind people who say hello as they are crossing the street so we can all keep a safe distance from one another.

On one of our walks, I told my wife that, in some ways, being a Follicular lymphoma patient has been pretty good preparation for all of this. I've always been very careful about staying away from sick people, washing my hands frequently, and generally trying to stay healthy.

I've also been preparing myself mentally for this. I have long followed a "3 Day Rule." All the cancer patients and survivors I know get that awful feeling when we find a new bump or unexplained pain. I've learned to give it 3 days. If I can't come up with an explanation for it, or it doesn't get better in 3 days, then I can call the doctor. It gives me a little time to stay calm. I rarely have to call the doctor.

But the last two weeks have been tough. I know the COVID-19 symptoms. I know what to look for. But it seems like every day, I've been feeling something. A headache. A slight cough. A scratchy throat. And I keep saying to myself, "Dammit. Here we go. It's starting." And then a half hour later, the headache is gone. Or I take a big drink of water, and the sore throat disappears.

It happens every day. I don't even have to wait 3 days -- the "symptoms" go pretty quickly. And I do have a reasonable explanation, as I look out the window and see trees budding and spring allergies kicking up.

But the stress is still awful. 

As you know, I try to pay attention to mental and emotional health. It's a really important part of our overall health as Follicular Lymphoma patients. It's a disease (as you know) where physical symptoms are sometimes easier to deal with than emotional symptoms.

So if you're feeling the kind of stress and anxiety that I'm feeling, maybe one of these resources will help. Some of the advice is repeated, but maybe that means it's good advice worth listening to.

 The Yale School of Medicine (with which I have a relationship) offers some general advice about Anxiety and COVID-19.

Blood-Cancer.com (a website that I write for) has some self-care tips.

The American Psychiatric Association's Center for Workplace Mental Health has a guide to maintaining well-being while working from home.

And finally, the National Alliance on Mental Illness has some coping strategies for dealing with COVID-19.


I think they are all useful, and if you are struggling with stress and anxiety, one or more of them may speak to you.

And if nothing else, know that there are plenty of us who are feeling the same way. I often take comfort in knowing that I'm not the only one who has certain feelings.

Most of all, if you're feeling isolated, reach out. Online communities aren't always great (I'm spending a lot less time on Twitter these days, because there's a lot there that upsets me), but online communities can be a great source of interaction and connection, too, if you find the right ones.

Feel free to reach out to me. Tell me how you're feeling. Share some coping strategies. And any D & D tips would be greatly appreciated.

Take care of yourselves.