Yi Lin, MD, PhD, discusses the promise of the CAR T-cell products ciltacabtagene autoleucel and idecabtagene vicleucel in patients with myeloma.
Yi Lin, MD, PhD, an assistant professor of oncology, associate professor of medicine, and a consultant in the Division of Hematology and Division of Experimental Pathology and Laboratory Medicine at Mayo Clinic, discusses the promise of the CAR T-cell products ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel) in patients with myeloma.
Both cilta-cel and ide-cel are under evaluation in pivotal clinical trials, says Lin. A biologics license application (BLA) has been submitted to the FDA for ide-cel, and the regulatory agency has granted the application priority review. The FDA is anticipated to make a decision on the BLA by March 27, 2021. Additionally, a rolling submission of a BLA for cilta-cel has also been initiated. Both CD19-directed CAR T-cell products could potentially be available for clinical practice in 2021, says Lin. The trials that have examined these products have evaluated their use in heavily pretreated patient populations with poor-risk cytogenetics and penta-refractory disease.
A single-dose infusion of either of these products in this patient population has been shown to elicit high overall response rates, with many patients achieving complete remissions or stringent complete responses, adds Lin. Notably, many of the patients who achieve remission are also found to have minimal residual disease negativity. These responses are significant in myeloma, especially because they have also proven to be durable, concludes Lin.