Dr Qiu on the Efficacy and Safety of Eque-Cel in Relapsed/Refractory Multiple Myeloma

“At this conference, we [presented] updated data after a median follow-up of 3 years. In the whole group, the median PFS was 30.5 month. For the 95 patients without prior CAR T-cell therapy, the median PFS was 35.9 months. In my impression, the safety profile [was] well [tolerated], and during the trial, approximately 95% of patients had CRS, but mostly grade 1 or grade 2.”

Lugui Qiu, MD, a professor and head of the Lymphoma and Myeloma Center at the China Academy of Chinese Medical Sciences, discussed updated 3-year follow-up results from the phase 1b/2 FUMANBA-1 trial (ChiCTR2000033946), which evaluated the fully human anti–BCMA CAR T-cell therapy equecabtagene autoleucel (eque-cel) in patients with relapsed or refractory multiple myeloma.

At a median follow-up of 36 months, eque-cel continued to demonstrate durable clinical activity with deep and sustained responses. Among 107 efficacy-evaluable patients, the objective response rate (ORR) was 96.3%, with 83.2% of patients achieving a complete response (CR) or better. In the subset of 95 patients who had not received prior CAR T-cell therapy, the ORR and CR rates were 98.9% and 88.4%, respectively.

The median progression-free survival (PFS) was 30.46 months (95% CI, 24.11-42.15) across all patients, 39.82 months (95% CI, 30.26-not estimable [NE]) among those achieving at least a complete response (CR), and 35.91 months (95% CI, 25.95-47.67) among those without prior CAR T-cell therapy. According to Qiu, the median overall survival (OS) had not been reached at the time of analysis, with 66.3% of patients remaining alive at 3 years.

Qiu also noted that the safety profile was mostly well tolerated. In the safety assessment, cytokine release syndrome was reported in 93.6% of patients, though only 1 effect was grade 3 or higher. Immune effector cell–associated neurotoxicity syndrome occurred in 2 patients, presenting as grade 1 and grade 2, respectively.