Dr Lin on the Rationale for Evaluating Cilta-Cel–Associated Late-Onset Toxicities in Myeloma

“We’ve had FDA-approved CAR T-cell [therapies] for patients with multiple myeloma for multiple years now. With the growing number of patients treated for multiple myeloma, we’re seeing some emerging signals in both clinical trials and standard practice, that … somewhere in that first 6 months, there may be some late[-onset] toxicities showing up.”

Yi Lin, MD, PhD, an assistant professor of oncology; consultant in the Division of Hematology in the Department of Internal Medicine; and enterprise leader of Cancer Regenerative Medicine, Biotherapeutics, and Biomanufacturing at the Mayo Clinic Comprehensive Cancer Center, shared the rationale for evaluating potential predictive factors for delayed infusion-related toxicities following the administration of ciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with multiple myeloma.

On April 5, 2024, the FDA approved cilta-cel and idecabtagene vicleucel (ide-cel; Abecma) for the treatment of patients with relapsed/refractory multiple myeloma. Cilta-cel was approved for the treatment of patients with relapsed/refractory multiple myeloma who received at least 1 prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and were refractory to lenalidomide (Revlimid). Ide-cel was approved for the treatment of adult patients with relapsed/refractory multiple myeloma after 2 or more prior lines of therapy, which included a PI, IMiD, and an anti-CD38 monoclonal antibody.

With a growing population of patients receiving CAR T-cell therapies, late-onset toxicities have increasingly been observed within the first 6 months post-infusion in both clinical trials and standard practice, Lin began. However, these delayed toxicities are not common, with an incidence of 5% or less, she noted. Of note, these adverse effects (AEs) include immune effector cell–related nerve palsies, parkinsonism, and enterocolitis, with the latter potentially causing hospitalizations due to extreme weight loss and lack of hydration, she explained. Determining which patients are at risk for developing these late-onset toxicities through real-world analysis could better inform toxicity prevention and increase vigilance when monitoring these toxicities, Lin concluded.