CAR-T Moving to Earlier Availability in Multiple Myeloma

There is currently an effort to offer treatment via CAR-T cell therapy to patients with multiple myeloma earlier in their cancer journey, as one expert explained during CURE®’s Educated Patient® Multiple Myeloma Summit.

“A lot of you had asked this question, can we give CAR-T cell therapy earlier?” noted Dr. Doris K. Hansen of theH. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, during her talk on CAR-T cell therapy. “So, there are a lot of clinical trials ongoing.”

CAR-T cell therapy, as defined by the National Cancer Institute, involves a patient’s T cells, part of the immune system, being extracted, changed in a laboratory to attack cancer cells, grown in the laboratory and infused back into the patient.

In 2021, Abecma (idecabtagene vicleucel) became the first CAR-T cell therapy approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma when it was approved for the treatment of adults who did not respond to at least four prior lines of therapy or whose disease returned after the same number of therapies. Abecma became available sooner to patients earlier this year, when the FDA approved it for adults with relapsed or refractory multiple myeloma who had received at least two prior lines of therapy.

Likewise, the FDA initially approved Carvykti (ciltacabtagene-autoleucel) in 2022 for adults with relapsed/refractory multiple myeloma who had received at least four prior lines of treatment. Earlier this year it was announced that the agency had approved Carvykti for patients who received at least one prior line of therapy.

“CAR-T cell therapy certainly has been a revolutionary therapy for patients with relapsed/refractory multiple myeloma, from the original approvals in 2021 [and] 2022, for patients who have had four or more prior lines of therapy,” Hansen said during the summit. “Now in 2024, just a couple of months ago, we had approvals in essentially second and third line of therapy. So significantly earlier in the line of therapy, we see deep and durable responses, patients are doing well.”

The research continues, as Hansen highlighted five current clinical trials that continue to analyze this issue.

The KarMMa-2 trial, findings of which were presented this month at the 2024 European Hematology Association Congress, showed that among patients with newly diagnosed multiple myeloma that progressed within 18 months of treatment initiation, one infusion of Abecma resulted in “frequent, deep, durable responses and a manageable safety profile,” according to researchers.

Similarly, findings of the CARTITUDE-2 trial, published last year in Blood, showed that patients who received Carvykti in earlier lines of treatment “experienced deep and durable responses.”

Additionally, Hansen spotlighted the currently recruiting KarMMa-9 trial evaluating Abecma among patients with newly diagnosed multiple myeloma who experienced a suboptimal response to stem cell transplant as well as CARTITUDE-5 and CARTITUDE-6, which are now recruiting and will evaluate Carvykti among patients with newly diagnosed transplant-ineligible and transplant-eligible multiple myeloma, respectively.

“We all had asked the question, was [stem cell] transplant better or CAR-T better? So, this CARTITUDE-6 study is what will speak to that,” Hansen said. “So, this study is currently ongoing in Europe and in the U.S., but essentially, this will compare randomized patients to transplant versus CAR-T. And then when study matures, you know, we can say, ‘Is one better than the other?’ So I think the study will answer the question, hopefully. And then CARTITUDE-5 is another study where we're giving Carty upfront after induction and this is for patients who are transplant ineligible, followed by [Revlimid (lenalidomide)] maintenance. So [there is] certainly a lot of excitement, a lot of exciting trials.”

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