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  • Phase III CARTITUDE-4 study of cilta-cel shows a r...

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

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Published:6th Jun 2023

Legend Biotech Corp announced that results from the Phase III CARTITUDE-4 study showed that, at a median follow up of 16 months, cilta-cel (ciltacabtagene autoleucel) reduced the risk of disease progression or death by 74 percent compared to standard of care regimens in adult patients with multiple myeloma who have received one to three prior lines of therapy and are refractory to lenalidomide (Hazard ratio [HR]=0.26 (95% CI, 0.18–0.38); P-value [P] <0.0001)

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).

Condition: Multiple Myeloma
Type: drug

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