Cilta-Cel Versus SOC for Refractory, High-Risk Myeloma in the Second Line

Ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR)-T cell therapy, improved outcomes versus the standard of care (SOC) in patients with lenalidomide-refractory, functional high-risk (FHR) multiple myeloma in second-line therapy, according to data presented at the Society of Hematologic Oncology 2024 Annual Meeting in Houston, Texas.

This post-hoc subgroup analysis of the CARTITUDE-4 study was led by Luciano Costa, MD, of the University of Alabama at Birmingham.

The study analyzed a subgroup of 136 patients who received either cilta-cel (n=68) or standard of care (n=68) therapy as second-line therapy. Of these, 79 had FHR disease—40 in the cilta-cel arm and 39 in the SOC arm.

According to the report, overall progression-free survival (PFS) was not reached in the cilta-cel arm (95% CI, not evaluable [NE]-NE) versus 17 months in the SOC arm (95% CI, 11-NE). Results were similar in the FHR subgroups with median PFS not reached in the cilta-cel arm (95% CI, 18-NE) compared with 12 months in the SOC arm (95% CI, 8-NE).

Cilta-cel was also favored versus SOC in rates of overall response (88% vs 80%), complete response or better (68% vs 39%), and measurable residual disease negativity (65% vs 10%). Median duration of response was not reached (range, 16-NE) with cilta-cel versus 16 months (range, 8-NE) with SOC. Grade 3 or higher treatment-emergent adverse events were recorded in 96% of patients in both overall groups.

“Cilta-cel improved outcomes versus [SOC] with a safety profile consistent with the mechanism of action of CAR-T therapies, suggesting cilta-cel may overcome poor prognosis associated with FHR multiple myeloma,” Dr. Costa and colleagues suggested.

Reference

Costa L, Weisel K, van de Donk N, et al. Ciltacabtagene autoleucel vs standard of care in patients with functional high-risk multiple myeloma: CARTITUDE-4 subgroup analysis. Abstract #MM-549. Presented at the Society of Hematologic Oncology 2024 Annual Meeting; September 4-7, 2024; Houston, Texas.