Carvykti Associated With Improved Survival in R/R Multiple Myeloma

One infusion of the CAR-T cell therapy Carvykti (ciltacabtagene autoleucel; cilta-cel) was associated with positive overall survival (the time a patient lives following treatment, regardless of disease status) results, according to recently announced study findings.

Legend Biotech Corporation announced in a news release that the ongoing phase 3 CARTITUDE-4 trial displayed “statistically significant and clinically meaningful” improvements to patients’ overall survival. Furthermore, the company stated that no new safety signals were identified.

CARTITUDE-4 is evaluating Carvykti versus Pomalyst (pomalidomide), Velcade (bortezomib) and dexamethasone, known as PVd, or Darzalex (daratumumab), Pomalyst, and dexamethasone, known as DPd, in adults with relapsed and Revlimid (lenalidomide)-refractory multiple myeloma. Patients must also have received one to three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

“We are gratified to have observed an overall survival benefit with a one-time infusion of Carvykti in the latest analysis of the CARTITUDE-4 study,” said Ying Huang, Chief Executive Officer of Legend Biotech Corporation, in the news release. “This latest data point builds on the growing body of evidence from CARTITUDE-4 that shows the significant benefit Carvykti offers multiple myeloma patients battling an incurable disease.”

The results will be presented at an upcoming medical meeting, according to the news release.

In April, based on the findings of CARTITUDE-4, Carvykti was approved by the Food and Drug Administration for the treatment of patients with relapsed or refractory multiple myeloma who are refractory to Revlimid and had previously received a proteasome inhibitor and an immunomodulatory drug. The treatment, according to Legend Biotech Corporation, is the first BCMA-targeted CAR-T cell therapy approved by the agency for the treatment of patients with multiple myeloma who have received at least one line of prior therapy.

In findings from CARTITUDE-4 published in The New England Journal of Medicine, researchers reported that 96.6% of patients experienced grade 3 or 4 (severe or life-threatening) side effects, with the most common being neutropenia (low count of neutrophils, a type of white blood cell; 89.9% of patients), thrombocytopenia (low platelet count; 41.3% of patients), anemia (low red blood cell count; 35.6% of patients), infection (26.9% of patients) and lymphopenia (low level of lymphocytes, a type of white blood cell; 20.7% of patients).

With 419 participants, CARTITUDE-4 is estimated to be completed in June 2027, according to its listing on clincialtrials.gov.

LEARN MORE: CAR-T Moving to Earlier Availability in Multiple Myeloma

CAR-T cell therapy such as Carvykti, as explained 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.

The FDA initially approved Carvykti in 2022 for adults with relapsed/refractory multiple myeloma who had received at least four prior lines of treatment. Following April’s approval, it is now available as a second line of treatment.

There has been a push in 2024 to move CAR-T cell therapy into earlier lines of treatment, as one expert previously noted during the CURE® Educated Patient® Multiple Myeloma Summit.

“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,” said Dr. Doris K. Hansen of the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, during the June 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.”

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