Dr. Jagannath on the FDA Approval of Cilta-Cel in Relapsed/Refractory Multiple Myeloma

Sundar Jagannath, MBBS, director of the Center of Excellence for Multiple Myeloma and a professor of medicine (hematology and medical oncology) at The Tisch Cancer Institute, Mount Sinai, discusses the FDA approval of ciltacabtagene autoleucel (cilta-cel; Carvykti) in relapsed/refractory multiple myeloma.

On February 28, 2021, 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. The approval was based on findings from the phase 1b/2 CARTITUDE-1 trial (NCT03548207), which demonstrated an objective response rate of 98% (95% CI, 92.7%-99.7%) with cilta-cel in this patient population. Additionally, the stringent complete response rate was 78% (95% CI, 68.8%-86.1%). The median duration of response was 21.8 months at a median follow-up of 18 months.

Updated findings from the study, which were presented at the 2021 ASH Annual Meeting and Exposition, demonstrated progression-free survival and overall survival rates of 60.5% and 74.0% at a median follow-up of 2 years, respectively. These data exceed historical responses with other novel agents, such as selinexor (Xpovio) and belantamab mafodotin-blmf (Blenrep), rendering the approval a significant breakthrough in multiple myeloma management that brings the field one step closer to cure, Jagannath concludes.