Eque-cel Demonstrates Robust Efficacy and Safety in Relapsed/Refractory Multiple Myeloma Patients with Renal Impairment: Results from the FUMANBA-1 Study Presented at IMS 2024
IASO Biotechnology
Cancer Treatment New Drug Developer
On September 26, Brazil time, IASO Bio presented its fully human BCMA-targeted CAR-T therapy—Idecabtagene Vicleucel Injection (Focuxin)—in a poster at the 2024 International Myeloma Society (IMS) Annual Meeting.®) The prognostic study data of FUMANBA-1 in the treatment of patients with relapsed/refractory multiple myeloma (R/RMM) and renal impairment. The study results indicateIdecabtagene vicleucel injection shows equivalent efficacy in R/R MM patients with renal impairment, has a good safety profile, and can also improve patients' renal function.。
Abstract Number:P-100
Abstract Title: Outcomes of R/R MM Patients with Renal Function Impairment Treated with Eque-cel in the Pivotal Phase 2 FUMANBA-1 Study
Display Time: September 26, 2024 (UTC-3)
The content of this poster is based on the FUMANBA-1 study (ClinicalTrials.gov Identifier: NCT05066646). This study included 91 patients who had no prior history of CAR-T therapy and received treatment with Icaritin injection. The median follow-up time was 18.07 months. Patients were divided into a renal impairment group and a non-renal impairment group based on whether their creatinine clearance rate (CrCl) was ≤70 ml/min at the time of CAR-T therapy. Among them, 28 patients belonged to the renal impairment group with CrCl ranging between 40 and 70 ml/min, while 63 patients were in the non-renal impairment group with CrCl >70 ml/min.
The results showed,In terms of efficacy, most baseline characteristics of the renal impairment group were comparable to those of the non-renal impairment group.The renal impairment group can also achieve rapid and deep remission comparable to the non-renal impairment group. The long-term efficacy in the renal impairment group is equivalent to that of the non-renal impairment group (as shown in Figure 1).In terms of safety, no significant difference in the incidence of CRS and severe CRS was observed between the two groups.In the non-renal impairment group, there was one case of grade 2 ICANS, while no ICANS occurred in the renal impairment group. The incidence of short-term severe cytopenia was slightly higher in the renal impairment group but recovered by day 60. In the study, 73.2% and 58.8% of patients showed further improvement in creatinine clearance from baseline at 14 days and 3 months after infusion of IASO Bio's equecabtagene autoleucel. (As shown in Figure 2)
Figure 1 Baseline Characteristics and Efficacy
Figure 2 CrCl Improvement
Conclusion: In the FUMANBA-1 study, patients with relapsed/refractory multiple myeloma and renal impairment who received Icarusel injection treatmentCan also achieve rapid, deep, and lasting relief., without affecting safety. And some patientsRenal function improved following the clearance of myeloma cells after infusion of IASO Bio's equecabtagene autoleucel.Provides a reference for CAR-T treatment in patients with moderate to severe renal impairment in real-world settings.
