Posted: Monday, June 12, 2023
Patients with lenalidomide-refractory multiple myeloma appeared to derive a progression-free survival benefit from a single infusion of ciltacabtagene autoleucel versus standard-of-care treatments, according to Binod Dhakal, MD, of the Medical College of Wisconsin, Milwaukee, and colleagues. The first results from the phase III CARTITUDE-4 trial, which were presented during the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract LBA106), highlight the potential for this B-cell maturation antigen–targeting chimeric antigen receptor (CAR) T-cell therapy to become a key therapeutic approach after first relapse.
“Ciltacabtagene autoleucel has not only shown that it delivers remarkably effective outcomes compared to patients’ current options, but also that it can be used safely earlier in the treatment phase,” said ASCO expert Oreofe Odejide, MD, of Dana-Farber Cancer Institute, in an ASCO news release.
After undergoing apheresis, patients who previously received one to three lines of treatment, including lenalidomide, were randomly assigned to receive ciltacabtagene autoleucel (n = 208) or standard-of-care treatment with either pomalidomide plus bortezomib and dexamethasone (n = 28) or daratumumab plus pomalidomide and dexamethasone (n = 183). In the ciltacabtagene autoleucel arm, patients underwent bridging therapy with the physician’s choice of the aforementioned standard treatments, followed by a single infusion of the experimental agent 5 to 7 days after lymphodepletion.
After a median follow-up of 16 months, ciltacabtagene autoleucel reduced the risk of disease progression or death by 74% (hazard ratio [HR] = 0.26; P < .0001). Compared with the standard treatments, ciltacabtagene autoleucel was found to significantly improve the rates of objective response, complete response or better, and measurable residual disease negativity; there was an observed trend toward significance for an overall survival benefit (HR = 0.78).
Most patients in both groups experienced grade 3 or 4 adverse events, including and cytopenias. Of those treated with ciltacabtagene autoleucel, 76% had cytokine-release syndrome, and 5% developed immune effector cell–associated neurotoxicity syndrome.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.