Eque-Cel Displays Favorable Long-Term Survival in R/R Multiple Myeloma

Among 107 patients with relapsed/refractory multiple myeloma treated with eque-cel, the objective response rate was 96.3%, with 83.2% of patients achieving at least a complete response.

Equecabtagene autoleucel (eque-cel), an anti-BCMA CAR T-cell therapy, exhibited favorable long-term survival outcomes among patients with relapsed/refractory multiple myeloma, according to findings from the single-arm phase 1b/2 FUMANBA-1 trial (ChiCTR2000033946) presented at the 22nd Annual International Myeloma Society Meeting and Exposition.

Among 107 patients with relapsed/refractory multiple myeloma treated with eque-cel, the objective response rate (ORR) was 96.3%, with 83.2% of patients achieving at least a complete response (CR). Additionally, among 95 patients not previously treated with CAR T therapy, the rates were 98.9% and 88.4%, respectively.

Additionally, the minimal residual disease (MRD) negativity rate among all patients was 95.3%, including 100% of patients who achieved at least a CR (n = 89) and 98.9% of those not previously treated with CAR T therapy (n = 95). The median duration of MRD negativity was 36.5 months (95% CI, 25.56-not evaluable [NE]). The respective 12-, 24-, and 36-month MRD negativity rates were 81.0% (95% CI, 71.2%-87.7%), 62.2% (95% CI, 50.6%-71.9%), and 50.2% (95% CI, 37.9%-61.3%), respectively.

Furthermore, the median duration of response (DOR) among patients treated with eque-cel was 31.3 months. Additionally, the median progression-free survival (PFS) was 30.5 months (95% CI, 24.11-42.15) among all patients, 39.8 months (95% CI, 30.26-NE) among those who attained at least a CR, and 35.9 months (95% CI, 25.95-47.67) among those who did not receive prior CAR T therapy. Moreover, the median overall survival (OS) was not reached among the total population, with 66.3% of patients alive at 3-year follow-up.

“At a median follow-up of 36 months, eque-cel showed promising long-term outcomes. The median PFS in all patients was 30.5 months; in patients who achieved a CR or better, it was nearly 40 months; [and] in patients without prior CAR T [therapy], it was nearly 36 months,” Lugui Qiu, MD, department head of the Institute of Hematology and Blood Diseases Hospital of the Chinese Academy of Medical Sciences in Tianjin, China, stated in the presentation. “Eque-cel demonstrated deep, durable responses and sustained MRD negativity in heavily pretreated [patients with] relapsed/refractory multiple myeloma, including those with high-risk features. The long-term safety profile remained manageable, with no new safety signals identified.”

The multicenter trial assigned patients 18 to 70 years of age with relapsed/refractory multiple myeloma following disease progression after 3 or more prior therapies to receive eque-cel infusion at a dose of 1 x 10⁶ CAR T cells/kg. A total of 17 patients were enrolled in the phase 1b portion of the trial, and an additional 102 entered the phase 2 study.

Prior to eque-cel infusion, patients received bridging therapy, if necessary, followed by lymphodepletion with 500 mg/m² of cyclophosphamide and 30 mg/m² of fludarabine. Additionally, post-infusion assessments occurred for up to 2 years after study treatment; long-term follow-up is planned for up to 15 years.

The median age among evaluable patients was 58 years (range, 39-70), and 53.2% of patients were male. Most patients had an ECOG performance status of 1 (78.0%), IgG histology (52.3%), and Revised International Staging System (R-ISS) stage II disease (65.1%).

A total of 12.8% of patients had extramedullary disease, 100% were double-class exposed, 23.9% received monoclonal antibodies, and 28.4% received stem cell transplantation. Additionally, 11.0% had received prior CAR T-cell therapy. The median number of prior lines of therapy was 4 (range, 3-23), and there was a median of 43.4 months (range, 6.6-193.2) since diagnosis.

The primary end point of the phase 1b portion of the trial was safety and tolerability; in the phase 2 portion of the trial, it was 3-month ORR post-infusion. Secondary end points included pharmacokinetics and pharmacodynamics, MRD, OS, DOR, PFS, and time to response.

In the safety analysis, cytokine release syndrome (CRS) occurred in 93.6% of patients, but only 1 case of grade 3 or higher emerged. Furthermore, immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 2 patients, with single grade 1 and 2 cases, respectively. No late-onset neurotoxicity or secondary malignancies were observed.

The median time to first onset of CRS was 6 days (range, 1-13), with a median duration of 5 days (range, 2-30). Additionally, the median time to first onset of ICANS was 6.5 days (range, 3-10), with a median duration of 1.5 days (range, 1-2).

Reference

Li C, Zou D, Zhou K, et al. Three-year follow-up of FUMANBA-1: a phase 1b/2 study of fully human anti-BCMA CAR-T equecabtagene autoleucel in patients with relapsed/refractory multiple myeloma. Presented at the 22nd Annual International Myeloma Society Meeting and Exposition; September 17-20, 2025; Toronto, Canada. Abstract OA-08.