Epcoritamab Gets FDA Priority Review

A quick bit of news: The FDA granted Priority Review status to Epcoritamab for Relapsed/Refractory Follicular Lymphoma.

Epcoritamab is a bispecific antibody. As a bispecific, Epcoritamab acts like a monoclonal antibody like Rituxan, by seeking out and attaching to a protein on the cancer cell (in this case, it attaches to the CD20 protein, just as Rituxan does). But then it dos something else -- it attaches to a protein (CD3) on a T cell, a kind of immune cell. By bringing the T cell close to the cancer cell, it helps the immune system work on the cancer.

The Priority Review means that the FDA thinks Epcoritamab will offer significant improvements in either safety or effectiveness over what is now available for R/R FL patients. It will make a decision in 6 months, rather than the usual 10 months, so it is likely to decide whether or not approve by June 28. 

The Priority Review is based on the phase1/phase 2 EPCORE trial. These results were presented at the ASH convention a couple of months ago. The results of that trial were very good; the Overall Response Rate was 82%, with a Complete Response Rate of 63%, comparable to Mosunetuzumab, the bispecific that is currently approved for FL patients. 

One thing that I find especially interesting is that they are considering approval based on a phase1/2 trial. Though it's fairly large for an early trial (128 patients), the FDA has also been sending signals that they want to slow down on accelerated approvals. They'd rather see full, phase 3 randomized trials instead, which are more reliable and give more time for potential side effects to come to light. I've actually been working on a post on that very subject; I may have to speed it up and get it on the blog soon.

Regardless, this is good news, assuming that everything goes well with the review. As I have said several times before, bispecifics are one of the treatment types that seem to get Lymphoma specialists most excited (and I include my own oncologist in that group). So another bispecific option would be great for all of us. 

More to come, I'm sure -- I'll keep an eye out for news and commentary about Epcoritamab, and share any good stuff I see. 

Survivorship Research

I've been thinking a lot about the idea of "survivorship" lately. 

In cancer terms, survivorship is what happens after treatment is finished, particularly after treatment has been successful. I've known lots of cancer patients who were just kind of on their own at that point (or maybe who felt like they were on their own).  Once the treatment is done, there's no need for a doctor anymore, right? Except for a couple of visits to make sure everything is still OK?

That was certainly the attitude for a long time. But more and more, cancer centers are creating and promoting "survivorship centers," with specialists who focus on helping out patients after they are "done." As many of us know, after a successful round of treatment, there is still a whole lot to deal with -- the many, complex emotions that come with cancer; physical changes, big and small; financial difficulties with lingering bills. There's a lot to deal with, even after the cancer cells are gone. It's great that more and more cancer centers are recognizing that, and equipping them with social workers, psychologists, nutritionists, pain specialists, and others who can provide some help. 

So how do all of these folks know what to do for cancer patients to help them? That's where survivorship research comes in. The ASCO Post has a nice piece about this subject from two people who know a lot about it -- the lead of evidence-based survivorship supportive care and the director of cancer survivorship and supportive care programs at the University of Miami Sylvester Comprehensive Cancer Center.

They  point out the many, many issues that Survivorship Clinics help patients with -- physical, emotional, and financial -- that I mention above. Add to that short list a few more -- issues with pain, fatigue, sleep, attention and memory, sexual function anxiety, depression. All of those things are very common problems for cancer survivors. It's good to know how common they are. I think a lot of cancer patients have difficulties and think "It's all over now. The cancer is gone. Is all of this in my head?" Probably not. It's good to know that there are places to go to get help.

And here's the good part. Survivorship research sometimes gets its data from clinical trials. Just like developing treatments, survivorship benefits from patients who are willing to be a part of a study. And just like trials for new treatments, survivorship trials often have trouble recruiting.

The ASCO Post article doesn't recommend any specific survivorship trials, but they do recommend a couple of places to look if you're interested in participating. The first is by looking at the National Cancer Institute's database of clinical trials and/or at the U.S. government's clinicaltrials.org site. Both are fairly easy to use. (And they're great for seeing all of the Follicular Lymphoma trials near you, not just the survivorship ones.)

The second is by looking at the websites for different patient support organizations. I've done the NHL search for you, so you can find a list of lymphoma organizations here. Some of them may be participating in, or helping to recruit for, survivorship trials. 

Now, I've talked about the importance of clinical trials many times on the blog, and I always try to find out what my oncologist is excited about in research, and whether my cancer center is doing any trials on it. But also know that cancer patients can be very hesitant about participating in a trial, since the treatments are unproven (that's the whole point f a clinical trial).  One of the great things about survivorship trials is that, in some ways, the stakes are lower. If a patient is worried about side effects of a new drug, the interventions for many survivorship trials do not involve physical side effects. Here's an example from the Mayo Clinic in Minnesota (which has an excellent survivorship program) -- breast cancer survivors who are taking endocrine therapy are in a trial to see if motivational interviews and text messages will help them to remember to continue their therapy. There may be some emotional side effects to a study like that, but not the physical ones that scare off lots of cancer patients from participating in a trial. (And just to be clear, it's worth talking to your oncologist about those fears. They may be fears about nothing, and a good talk with lots of honest questions might calm a lot of those fears.) 

I also know that, for many Follicular Lymphoma patients, the whole idea of "survivorship" can be a tricky thing. The idea that FL is incurable is always in our minds. What does it mean to be a "survivor" if there's a chance that it might come back soon? Is it worth going through the things that "survivors" go through?

I would say yes, absolutely. The National Cancer Survivors Day folks tell us that anyone who has ever been diagnosed and is still alive is a survivor. There's no 5 year waiting period or anything like that. Different survivorship trials might have certain criteria to participate, which is understandable. But being finished with active treatment, no matter what the status, should be enough to make it worth looking into some trials. (Here's another example -- Sloan Kettering in New York has one comparing Music Therapy and Cognitive Behavioral Therapy to treat anxiety in cancer survivors.)

And your status as a survivor certainly opens the door to whatever survivorship benefits are available to you at your cancer center. And if your cancer center doesn't have a survivorship clinic, or you go to a community oncologist in a smaller office, then ask if there are any services for survivors. I'm guessing they're have some suggestions.

Most importantly, be sure to continue to take care of yourselves, physically and emotionally, long after you are finished with any treatment. There's help for you if you need it. 

Upcoming LRF Event

As you may know, I like to promote some of the webinars and workshops the the LRF (the Lymphoma Research Foundation). I've been able to attend them in person and online, and I think they're great. They usually involve one or more oncologists giving a presentation, and then time for questions and answers. Sometimes the topics are very general, and sometimes they are very specific. But the LRF usually does a great job of finding speakers who know the latest research on Lymphoma, and who can explain things clearly. 

There is a big  LRF event coming up that is worth attending -- the "National Lymphoma Workshop: Understanding Lymphoma Basics and Current Treatment Options."

This a virtual workshop, so everything is online. The date is Saturday, March 16, and it runs from 9:30am to 1:30pm. The first part of the webinar is a general overview of Lymphoma. After there, there are individual sessions for different types of lymphoma, including one for Follicular Lymphoma, led by Dr. Laurie Sehn of the British Columbia Cancer Agency. (Dr. Sehn was one of the panelists from the video series that I linked to a couple of weeks ago. She knows her stuff.)

After a break, there are two more general sessions -- one on Nutrition with Peter Adintori of Memorial Sloan Kettering Cancer Center, and one on Integrative Medicine with Dr. Santhosshi Narayanan of MD Anderson Cancer Center. These should be very good. I'm especially interested in the Integrative Medicine session, which will look at the ways traditional cancer treatment can be supplemented with other practices. Always a fascinating topic.

You can use the link above to see the full agenda and to register for the workshop. As I said, the LRF does a good job of finding speakers who can explain things well. This workshop should be the same way.

I hope some of you can find time to attend, and get something out of it.

How to Read Survival Statistics

A couple of weeks ago, a reader made a comment about Overall Survival, and I gave a brief response. But I know there are some new readers here who were diagnosed fairly recently, so I think it's a good time for a reminder about "Overall Survival" and what it means.

It's especially important for folks who are newly diagnosed. For most of us, when we heard those words -- "You have cancer" -- our minds immediately went to some variation of "How long do I have?" Survival statistics serve as a kind of easy way to figure out how worried we should be. 

But survival statistics don't tell us anything about our own situations. It's easy to read a statistic that says the survival rate for a cancer is X years, and say "Well, I only have X years left." That's just not true. That's not how statistics work.

I'll use myself as a quick example. When I was diagnosed in 2008, the Median Overall Survival for Follicular Lymphoma was thought to be 8-10 years. Here I am, 16 years later. 

One of the problems with that 8-10 year statistic is that it was probably already outdated when I saw it. At that point, Rituxan had been in use widespread for FL for about 10 years (it was approved by the FDA in 1997). Rituxan is generally credited with increasing the Median Overall Survival, which had probably already done by the time I was diagnosed. But that 8-10 year figure was from the last large study of  FL survival, done before Rituxan, and looking backwards anyway, measuring the survival rate of people who were diagnosed in the 1980s. 

So that's the first danger with looking at survival statistics and thinking they are a measure of your fate -- they're probably outdated, maybe very outdated, and don't take into account any newer treatments.

As for the other problems, let's look at the term "Median Overall Survival," which is the official term for survival statistics. 

First of all, it's important to remember what "Overall Survival" is measuring. This statistic looks at death from any cause, not from the disease being considered. A statistician looks at a bunch of records of cancer patients, marks which have died, and notes when it happened. Those deaths aren't distinguished by cause. So it includes people who died from their cancer. And people who died from complications of their treatment. But it also includes people who died from heart disease, car accidents, getting too close to wildlife at national parks -- any cause of death. "Overall Survival" simply looks at how many people died, and how long they lived after they were diagnosed.

That's especially important for Follicular Lymphoma patients. We are generally diagnosed with FL sometime in our 60's (I haven't seen a solid statistic for this anytime recently). So for a group of people who are diagnosed fairly late in life, we can probably expect a lifespan of 15-20 years. That just makes sense -- anyone at the age of 65 (whether they have FL or not) probably has a life expectancy of about 15-20 years. 

And that is indeed about what researchers put as Median Overall Survival -- about 15-20 years. In other words, as a group, we're pretty much in line with the general population.

The other important word in this formulation is "Median." That's a term from statistics. It's different from "average," because one big number can throw off an average. "Median" means the exact middle. So if you had 999 Follicular Lymphoma patients, and you lined them up based on how long they survived after diagnosis, then number 500 in that line up would be the median. (There would 499 on either side of that patient.)

Since the "median" is the exact middle, that means 499 of those patients would have a shorter survival than #500. But it also means that 499 would have a longer survival.

Think about that. If #500 has a survival rate of 20 years, that means half of us will have a survival rate of greater than 20 years. How much greater? Maybe 20 years and 1 day. Maybe 25 years. Maybe 50. 

That's especially important for us who were diagnosed on the young side. Like me -- I was diagnosed at 40 years old. That doesn't mean I can expect to only live a few more years. The patients on the right side of #500 don't have an upper limit. Statistically, I could live until I'm 90 -- a 50 year survival rate. 

(By the way, that's how long I expect to live -- at least.)

But what about those folks who were to the left of #500? That still doesn't mean anything. It includes people who didn't know they had FL until very late in their lives, maybe in their late 70s, and then had a normal life expectancy. It includes people who didn't get a diagnosis until their disease was very far along. It includes people who walked out of the doctor's office after getting a diagnosis and had a piano fall on them 5 minutes later. 

The point is this -- statistics are not destiny. The numbers that describe a group of thousands of people, especially because they are collected by looking at the past, don't tell us anything about us as individuals. Our lives are all different, and our diseases are different.

I personally stopped looking at statistics a long time ago. When I was first diagnosed, the things that threw me into a depression were almost always statistics.  Numbers seem so definite, so correct, so real. And it's very easy to get sucked up into them and take them as the truth about ourselves. But that;s just not how it works. 

So if you want some numbers, here is a good one. 

A long time ago, a reader told me that her doctor was discussing treatments with her, and how excited he was about there being so many new options in the pipeline. The doctor told her "If we can keep a Follicular Lymphoma patient alive for 5 years, we can keep them alive for 50 years."

And that conversation happened before CAR-T, before bispecifics, before R-squared. And who knows what other treatments that might be coming soon.  

If you feel yourself getting pulled down by numbers, keep that one in mind.

I hope this helps some newer folks to better understand what survival statistics actually mean, and how little significance you should give to them. And I hope those of you who have been around for a while appreciate the reminder. Numbers are not destiny.

Take care.

World Cancer Day

Today is World Cancer Day, an event sponsored by the Union for International Cancer Control. In case you are wondering what "cancer control" is, here is how the UICC defines it:

Cancer control aims to reduce the incidence, morbidity and mortality of cancer and to improve the quality of life of cancer patients in a defined population, through the systematic implementation of evidence-based interventions for prevention, early detection, diagnosis, treatment, and palliative care.

 In other words, their aim is to support cancer patients throughout the cancer experience, from preventing it from happening to making them more comfortable when they do have it. 

And so Word Cancer Day is meant as a day of awareness. As I have said in the past, I'm really not in need of awareness -- I am made of aware of cancer literally every day of my life. But cancer awareness is about making others aware, and World Cancer Day is not different from mother awareness campaigns. Making others aware means helping them prevent it, detect it, and support funding for research to get rid of it. All of that matters -- those of us who have been diagnosed know that all too well.

The theme for this year -- actually for the last three years -- has been "Close the Care Gap." The UICC wants to highlight the disparities in cancer. Not everyone is able to get screened, or diagnosed, or treated in an equal way. So over three years, they have highlighted the problem, the ways that action can be taken, and now this year,  they encourage is all to "challenge those in power." Together, we can demand that leaders prioritize cancer and its eradication.

It's a great goal, and anyone who has been unable to get what they need really understands what this theme is all about. In the United States, cancer care is often a problem because of our healthcare system, which certainly creates disparities. I'm guessing many of you have had the experience of not being able to get something you wanted or needed. But that's not just a problem in the United States. Health systems in other countries need to prioritize care, meaning some treatments aren't available to some patients. And in still other countries, some treatments that have been approved in the US or the EU are not available to patients.

So this year's World Cancer Day is about working to make those differences go away. Doing so can be as simple as clicking on the "Call to Action" link on the World Cancer Day website. Or maybe there's more you want to do. A group like the Leukemia and Lymphoma Society would welcome your help in getting our leaders to pay more attention to the needs of cancer patients.

So while World Cancer Day only lasts for one day, the need keeps on going. And there are are lots of opportunities to  help.

Of course, lots of cancer patients don't ave the energy or the resources to do what they'd like, and that's OK, too. We do what we can.

But for those of you who can, please do consider spreading awareness and getting the message out. It can only help you.