Surbhi Sidana, MD, on Cilta-Cel's Efficacy in Second-Line Relapsed/Refractory Multiple Myeloma

This video originally appeared on our sister site, OncLive®.

“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.”

The chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel; Carvykti) was evaluated for the treatment of relapsed/refractory (r/r) multiple myeloma (MM) in the phase 3 CARTITUDE-4 clinical trial (NCT04181827). Specifically, the CAR-T was compared to standard-of-care (SOC) pomalidomide (Pomalyst) plus bortezomib (Velcade), and dexamethasone (PVd) or daratumumab (Darzalex) plus pomalidomide and dexamethasone (DPd).

In an interview with CGTLive®'s sister site, OncLive®, 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, spoke about the efficacy of the CAR-T, explaining that data from the study previously demonstrated a progression-free survival (PFS) benefit with cilta-cel, supporting the FDA approval of the CAR-T for the second-line. She noted that cilta-cel is approved for use in patients with r/r MM who received 1 or more prior lines of therapy, which must have included a proteasome inhibitor and an immunomodulatory agent, and whose disease is 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.