Susan Bal, MD, discusses the clinical implications for the use of ciltacabtagene autoleucel in patients with relapsed/refractory multiple myeloma.
Susan Bal, MD, assistant professor, Hematology, Medical Oncology, University of Alabama at Birmingham (UAB), UAB Health, O’Neal Comprehensive Cancer Center, discusses the clinical implications for the use ofciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with relapsed/refractory multiple myeloma.
In February 2022, the FDA approved cilta-cel for the treatment of adult patients with relapsed/refractory multiple myeloma following 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This made cilta-cel the second CAR T-cell therapy approved in the multiple myeloma space, following idecabtagene vicleucel (ide-cel; Abecma), which was FDA approved in March 2021 in the same indication.
The approval of cilta-cel was supported by data from the phase 1b/2 CARTITUDE-1 trial (NCT03548207), where patients were treated with a single infusion at a target dose of 0.75 x 106 CAR-positive viable T cells/kg (range, 0.5 x 106-1.0 x 106).
The baseline characteristics of the patients enrolled in this study were similar to those included in the phase 2 KarMMA trial (NCT03361748), which supported the FDA approval of ide-cel, Bal says. Notably, 88% of patients were triple-class refractory, and 99% were refractory to their last lane of therapy received.
Although 95% of patients in the cilta-cel arm experienced any-grade cytokine release syndrome (CRS), only 5% of patients had grade 3 or higher CRS. Among 97 patients who received cilta-cel during the trial, immune effector cell–associated neurotoxicity syndrome (ICANS) occurred in 23% of patients. Three patients had grade 3 or 4 ICANS, and 2 patients had grade 5 ICANS. Late onset neurotoxicity, such as peripheral neuropathies and neurocognitive changes, were also reported, Bal expands.
To better understand the differences between cilta-cel and ide-cel, ongoing monitoring of evaluable patients is required, Bal details. Treating clinicians continue to be excited with the efficacy that has been seen with these FDA-approved CAR T-cell therapies in clinical practice, Bal concludes.