Hello.
My name is Luciano Costa.
I'm a myeloma physician at University of Alabama at Birmingham.
Glad to be here at ASH 2025 and be able to address my friends at the HealthTree.
At this meeting, I had a chance to present the long-term follow-up of Cilta-cel on the CARTITUDE-4 trial for patients with standard-risk multiple myeloma.
As some of you may recall, the CARTITUDE trial was a trial that brought Cilta-cel, a BCMA-directed autologous CAR-T cell therapy, for patients with 1 to 3 prior lines of therapy.
There was lenalidomide-refractory, NPI-exposed, and this trial was a very positive trial with improvement in progression-free survival and overall survival.
Because this therapy has unique toxicities and has some complexity in delivery, due to the need to facilitate therapy center apheresis and so forth, many of us have prioritized it for high-risk patients.
And so it's important to analyze and examine the outcomes of patients who have standard cytogenetic risk who go on this therapy.
On this trial, there were close to 60 patients who had standard cytogenetic risk yet fit eligibility for CARTITUDE-4.
That definition was patients without 1q gain/amplification, t(4;14), t(14;16), or deletion of 17p.
We looked at that patient population, but also looked at a patient population that included 1q, in order to make a parallel with the CARTITUDE-1 trial, which is a trial for much later, more refractory disease, also treated with Cilta-cel.
What we saw is that for standard-risk patients treated with this therapy, the progression-free survival at 30 months is over 80%, and 73% for patients with standard risk including 1q gain.
If you compare this with the patient population in CARTITUDE-1 with more refractory disease, the PFS was about 60%.
So clearly, the use of this therapy early on gives, not surprisingly, far better results.
Another important point is that patients who made it to the end of the first year—the majority of them, more than 80%—93% are progression-free at a year and a half later, two and a half years from treatment.
And that is quite remarkable, speaking to the sustainability of this response.
If you look at the patients who were MRD negative at one year, which are 86% of those patients, not a single one had a progression for the duration of follow-up of this study.
Of course, we love to see longer-term data, like five years, so it could have a parallel with CARTITUDE-1.
In CARTITUDE-1, we saw that one in every three patients are alive, disease-free, and disease undetectable for five years.
This data gives us the expectation that that proportion is going to be much higher in patients with standard risk who receive this very effective therapy early on.
HealthTree • December 12, 2025