My name is Doctor Ciara Freeman.
I work at the Department of Blood and Bone Marrow Cellular Therapy at the Moffitt Cancer Center in Tampa, Florida.
I'm here at the Annual Society of Hematology meeting in San Diego, and I'm excited to share data about a novel CAR-T cell therapy which is being developed.
CAR-T cell therapy is a treatment that has really changed how we treat patients with multiple myeloma.
It's a therapy that's quite involved in that. We have to take a patient's own immune cells out.
We engineer them to recognize our cancer, and then we put them back into the patients to recognize and kill their cancer on the inside.
So it's a really personalized approach to therapy.
And there are two products that have been FDA approved CAR-T cell therapies for patients with relapsed or refractory disease.
And the data that I'm going to present today are preliminary results from a trial called the IMMagine-1 study.
And the CAR T-cell product itself is called anitocabtagene autoleucel.
It's got a big, long name, but its short version is anito-cel.
And this product is different in that it's the way that it binds to the tumor cells.
It's got this little tiny binding motif.
And the reason that that may confer an advantage is because it's easier to get that into the cell.
And so the cell expresses more of it on its surface.
And you can potentially give a more effective dose to patients as a result and maybe have enhanced outcomes in cell killing.
So these preliminary results that I'm going to share at the meeting, here in San Diego,
are about patients who were treated with multiple prior lines of therapy.
So they had to have had at least three prior lines of therapy.
And seeing all the classes of drugs that we commonly use in myeloma.
So immunomodulators like Revlimid, proteasome inhibitors like velcade or kyprolis, patients may know those.
And anti-CD38 monoclonal antibodies like daratumumab.
So they have to have seen all of those and their disease still has to come back.
And to be eligible for the study, they had to be refractory or progressing to the most recent treatment line that they were on.
And these patients all underwent, where we took their cells out of their body, sent them away to be manufactured.
The manufacturing rate was very high.
We were able to make effective cell doses for 99% of the patients enrolled.
And when we put these cells back into the patients, they had very deep and durable responses.
So the overall response rates that we've put in to the preliminary results are at 95%.
That's very high response rates for this kind of patient population.
And over 60% of patients that were treated when we checked their lab work and checked their bone marrow,
there was no evidence of myeloma that we could find.
That's called a complete response or better than continuous forms.
So these cells were able to engineer very deep and durable responses,
the kind of side effects that we see from these products are a lot of patients get a fever that's manageable,
and we take care of that in centers where we use CAR-T cell therapy.
That's something that we do routinely.
And very few patients, less than 10%, developed any kind of neurological side effects that commonly are associated with that fever, that inflammatory storm.
And what was really interesting is that across the whole program with this CAR T-cell product,
there have not been any reports so far of any other neurological toxicity.
So some of the other products that we use can sometimes cause other late-onset neurological toxicities,
like slowness of movement or sometimes, issues with the cranial nerves,
like a Bell's palsy, which some patients may be familiar with.
So far that hasn't been reported at all with this product.
So the early very preliminary data that we're excited to share
looks like these cells are able to engineer very deep and durable responses in patients who got relapsed disease.
It's seen all these previous lines of therapy.
And so we're excited to see with longer follow-up how long these responses last.
And obviously, we will have more follow-up in the future when the whole trial has completed enrollment.
And we finished accrual, as of now.
So the trial has completed accrual now.
So this early phase two portion of the study is now completed accrual.
This is a registration study.
So it may lead to an approval for this product for patients
that is waiting to be seen when they apply for FDA approval.
There is a new trial coming down the line involving this product
where they're going to randomize patients. So flip a coin.
Half of the patients will get standard of care chemotherapy regimens,
combinatorial regimens, and the other half will get CAR-T cell therapy.
And that's basically to demonstrate that compared to an alternative regimen
that's approved in patients who've had 1 to 3 prior lines of therapy,
whether or not CAR-T cell therapy with anito-cel can be better, can improve outcomes.
Other trials similar to this in nature have shown that CAR-T cell therapy
generally does outperform those combinatorial traditional approaches to treating myeloma.
So that trial has just started enrolling, and it's going to be open at multiple
centers across the world.