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Anti-BCMA CAR-T Cell Therapy Found Safe, Effective in Extramedullary MM
Two phase 1 investigations evaluated the safety and pharmacokinetic (PK) efficacy of anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cells in patients with relapsed or refractory (R/R) extramedullary multiple myeloma (EMM) and non-EMM. (Front Immunol. 2021 Aug 5. Epub ahead of print).
“The prognosis of R/R MM patients with extramedullary disease is significantly poor. EMM patients generally gain limited benefits from traditional drugs. BCMA CAR-T cell therapy seems to be a promising approach to treat this patient population,” explained Que Yimei, Huazhong University of Science and Technology, China, and co-researchers.
Both trials were conducted in single arm settings with a total of 61 patients (EMM 25 and non-EMM 36) who were inducted to anti-BCMA CAR-T cell infusion.
Findings show no statistical differences between EMM and non-EMM groups regarding adverse events (AEs), particularly cytokine release syndrome (CRS). The most common AEs of grade 3 or higher in both groups were hematologic toxicities.
“There were no significant differences in the objective response rate (ORR) and ≥ complete remission (CR) rate between both groups. However, the ≥ CR rate of the EMM group was lower than the non-EMM group who received anti-BCMA CAR-T cell therapy (p = 0.026),” continued Dr Yimei, et al.
The median progression-free survival (PFS) for both groups was 121 days and 361 days, respectively (p = 0.001). The median overall survival (OS) for both groups was 248 days and 1024 days, respectively (p = 0.005).
These results indicate extramedullary disease was an independent prognostic risk factor for PFS (HR, 2.576; 95% CI, 1.343 to 4.941; p = 0.004) and OS (HR, 2.312; 95% CI, 1.165 to 4.592; p = 0.017) in R/R MM patients receiving anti-BCMA CAR-T cell therapy.
“Anti-BCMA CAR-T cell therapy is safe and effective for EMM. However, EMM patients had a shorter PFS and OS compared with non-EMM patients,” concluded Dr Yimei, et al. –Alexa Stoia
