Equecabtagene autoleucel (eque-cel), a fully human-derived B-cell maturation antigen-targeting chimeric antigen receptor (CAR) T-cell therapy, has exhibited potential for the treatment of relapsed or refractory multiple myeloma (R/RMM).
On June 30,2023,China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO (Equecabtagene Autoleucel）,the world’s first fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of R/RMM who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent.
On November 07, 2024，IASO Biotherapeutics announced that the results of the phase 1b/2 clinical study FUMANBA-1 of its fully human anti-BCMA CAR-T therapy, Equecabtagene Autoleucel (trade name: Fucaso™), for the treatment of R/RMM, have been published in the leading medical journal JAMA Oncology. The study evaluated the efficacy and safety of Equecabtagene Autoleucel in patients with R/RMM who had previously received ≥3 lines of prior therapies. The results demonstrated that Equecabtagene Autoleucel achieved a high overall response rate and durable remission in patients, with a favorable safety profile.
FUMANBA-1 is a single-arm, open-label phase 1b/2 registrational clinical study conducted in 14 Chinese centers to assess the efficacy and safety of the Equecabtagene Autoleucel in patients with R/RMM who have received ≥3 lines of prior therapies. The trial enrolled patients with R/RMM who had previously received at least three lines of therapy, including proteasome inhibitors and immunomodulatory agents-based chemotherapy regimens, and had disease progression on their last line of therapy. Patients who had previously received BCMA CAR-T therapy were also eligible for enrollment.
Results Of 103 patients who received an eque-cel infusion, 55 (53.4%) were male, and the median (range) age was 58 (39-70) years.At a median (range) follow-up of 13.8 (0.4-27.2) months, In terms of efficacy, among the 101 evaluable patients, the overall response rate (ORR) was 96.0% (97/101), and the stringent complete response/complete response rate (sCR/CR) was 74.3% (75/101). Among the 89 patients without prior CAR-T therapy, the ORR was 98.9% (88/89), and the sCR/CR rate was 78.7% (70/89). In these 101 patients, the median time to response was 16 days (range: 11-179), while the median duration of response (DOR) and median progression-free survival (PFS) had not been reached yet. The 12-month PFS rate was 78.8% (95% CI: 68.6-86.0). Additionally, 95% (96/101) of the patients achieved minimal residual disease (MRD) negativity, with a median time to MRD negativity of 15 days (range: 14-186). All patients with sCR/CR achieved MRD negativity, and the median duration of MRD negativity had not been reached.
Conclusions and Relevance In this trial, eque-cel led to early, deep, and durable responses in patients with heavily pretreated R/RMM with a manageable safety profile. Patients with prior CAR T-cell therapy also benefitted from eque-cel.
At present, there are many other CAR-T clinical trials in China, and they are looking for patients. For consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
References
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20230630195006116.html
2.https://en.iasobio.com/info.php?id=224
3.http://js.news.cn/20230926/c8e67444df624a5ea654dda3aa608689/c.html
4.https://en.iasobio.com/info.php?id=256
5.https://jamanetwork.com/journals/jamaoncology/article-abstract/2826068
Post time: Nov-13-2024