Phase III CARTITUDE-4 study of cilta-cel shows a reduced risk of death or disease progression by 74% in multiple myeloma

Eligible patients in the cartitude-4 study had one to three prior lines of treatment, including proteasome inhibitors (pi) and immunomodulatory drugs and were lenalidomide-refractory. four hundred and nineteen patients were randomized, with 208 patients in the cilta-cel arm and 211 patients in the soc arm. at the median follow up of 16 months, the median pfs had not yet been reached in the cilta-cel arm (95% ci, 22.8-ne), compared to a median pfs of 11.8 months in the soc arm (95% ci: 9.7-13.8). in patients who had one prior line of therapy, there was a 65 percent (hr="0.35;" 95 percent ci, 0.19-0.66; p><0.0001) reduction in the risk of disease progression or death. among the secondary endpoints, the overall response rate (orr) was 85 percent, 73 percent achieved a complete response (cr) or better, and the rate of overall minimal residual disease (mrd) negativity reached 61 percent in the cilta-cel arm.

In the study, 97 percent and 94 percent of patients treated in the cilta-cel and SOC groups, respectively, had grade 3 or 4 adverse events, including infections (27 percent versus 25 percent) and cytopenias (94 percent versus 86 percent). Overall, 39 patients in the cilta-cel arm and 46 patients in the SOC arms died, of which 10 cilta-cel and 5 SOC patients passed due to treatment-emergent adverse events (TEAEs). In patients who received cilta-cel as study treatment (n=176), 76 percent had cytokine release syndrome (1 percent grade 3; no grade 4 or 5) and 5 percent had immune effector cell associated neurotoxicity syndrome (all grade 1 or 2). One grade 1 movement and neurocognitive treatment-emergent adverse event was reported in the cilta-cel group. Among patients treated with SOC therapies, the ORR was 67 percent, and 22 percent achieved a CR or better, while 33 percent of patients treated with SOC therapies were MRD negative.

The study data were featured in a press briefing and presented in an oral session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA106) and were presented in the New England Journal of Medicine. On Saturday, June 10, 2023, results will also be presented in a plenary session at the 2023 European Hematology Association (EHA) Hybrid Congress (Abstract #S100).