Continuing our look at what Lymphoma experts have to say about presentations at ASH a couple of weeks ago. I'm seeing lots and lots of commentary about Tafasitamab + R-Squared (the excitement was there even before the ASH meeting began, so no surprise there).
One commetary caught my eye this morning. It's from the lead researcher for abstract #864, "5-Year Follow-up Analysis from ZUMA-5: A Phase 2 Trial of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma."
The commentary is from an article website Health Day, and features a video (with written transcript) from a Leukemia specialist and a Lymphoma specialist. The Lymphoma specialist is Dr. Sattva Neelapu from MD Anderson, who discusses the abstract above.
The presentation looks at data from the ZUMA-5 trial. There are a series of ZUMA trials, each looking at the CAR-T known as Axi-cel or Yescarta, but looking at the effects from different patient populations. ZUMA-5 focuses on patients with indolent NHL, including Follicular Lymphoma, who had relapsed or refractory disease. The ZUMA-5 trial actually resulted in Axi-cel being approved for R/R FL in 2021, so this research isn't about trying to show the FDA that it is safe and effective. We already knew that.
Instead, this presentation is meant to show that Axi-cel remains safe and effective.
The study involved 159 patients, with 127 of them having been diagnosed with Follicular Lymphoma. The patients in the study had already received at least two other treatments, including immuno-chemotherapy (like R-CHOP or B-R). This presentation looks at what happened to the patients after 5 years.
In the video, Dr. Neelapu says the Overall Response Rate was 90% and the Complete Response Rate was 75% -- even higher in patients with Follicular Lymphoma at 79%.
The median Duration of Response -- how long it kept the cancer away -- was a median of 60.4 months, or a little over 5 years. (Median means half had a longer response and half had a shorter response).
Among patients who achieved a CR, 58% remained in response after 5 years. The Progression Free Survival rate was similar at 50.4%. For patients with a Partial Response, the PFS was 6.9 months. The median Overall Survival was not reached. To get a median, you need half of the patients to have died, so after 5 years, more than half were still alive -- the researchers estimated 69% of the patients were still alive after 5 years.
Among patients with Follicualr Lymphoma, the OS was estimated at about 65%, meaning 35% of the patients had died, whether from disease progression or from some other cause. These other causes included some secondary cancers and infections, as well as non-cancer-related causes.
I their conclusion to the abstract, and in the video, the researchers say that the results show that Axi-cel may have the potential to be a cure for a certain subset of patients.
I have a couple of thoughts.
First, looking at the numbers, it's clear that CAR-T is improving. The early results from CAR-T showed that roughly 33% of patients had a long duration of response, 33% had a duration of about a year, and 33% did not respond at all. The numbers here after 5 years are a lot better. CAR-T is working, and after some time, oncologists are getting better at dealing with side effects and with identifying who will be helped by CAR-T.
Second, that word "cure." It's a funny word when it comes to Follicular Lymphoma. Clearly, CAR-T was not a cure for a whole lot of patients in the study. But clearly, it has been a huge help to a whole lot of others. The problem with using that word is that "cure" is hard to measure. In other cancers, the 5 year mark is often used to declare someone as "cured." But FL has a habit of coming back even after 5 years, at least for some people.
But many oncologists use the term "functional cure." If an FL patient is diagnosed at a later age and has a treatment that lasts for as long as they live, we can call that "cured." And for others, the disease may return, but in a less-aggressive way that doesn't require treatment. That makes them "cured," in a sense.
Many FL patients use the phrase "Dying with the disease, not from the disease." And that amounts to a "cure" in a way, too.
I have my own issues with the word "cure," obviously, and I may write more about that sometime soon. But for now, we at least agree that for many patients, Axi-cel CAR-T has been very successful.
I'm still sifting through some other post-ASH commentaries. I'll share more soon.
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