Dr Sidana on the Efficacy of Second-Line Cilta-Cel in Relapsed/Refractory Myeloma

“What we have seen in the couple of years is that there is a PFS benefit that led to the FDA approval of cilta-cel in the second line.”

Surbhi Sidana, MD, an associate professor of medicine and associate director for Clinical Research in the Bone Marrow Transplantation and Cell Therapy Division at Stanford University, discussed the efficacy of ciltacabtagene autoleucel (cilta-cel; Carvykti) for the treatment of patients with relapsed/refractory multiple myeloma.

The phase 3 CARTITUDE-4 trial (NCT04181827) evaluated cilta-cel compared with standard-of-care (SOC) pomalidomide (Pomalyst) plus bortezomib (Velcade), and dexamethasone (PVd) or daratumumab (Darzalex) plus pomalidomide and dexamethasone (DPd) for the treatment of patients with relapsed/refractory multiple myeloma. Previously, data from the study demonstrated a progression-free survival (PFS) benefit with cilta-cel, which supported the April 2024 FDA approval of this agent as second-line therapy, Sidana began. The agent is indicated for patients with relapsed/refractory multiple myeloma who have been previously treated with at least 1 line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide (Revlimid).

Furthermore, data from survival subgroup analyses, presented at the 2025 ASCO Annual Meeting, revealed that patients with high-risk cytogenetics had improved PFS and overall survival (OS) with cilta-cel compared with SOC, Sidana continued. The analysis also included patients with extramedullary disease that was not contagious to the bone, she explained. Although this was a small subset of patients, those treated with cilta-cel had a median PFS of 12.6 months compared with only 4.0 months in those treated with SOC, she asserted. However, the 12.6-month median PFS demonstrated that this is an area of improvement and requires additional strategies.

Additionally, the subgroup analysis evaluated cilta-cel after 1, 2, and 3 prior lines of therapy, Sidana continued. Notably, there was benefit observed in all these subgroups, which suggested that cilta-cel is a superior therapy regarding PFS. Additionally, OS trends supported cilta-cel in each subgroup, she concluded.