IasO Bio and Innovent Biologics Present Oral Report on Equecabtagene Autoleucel (IBI326/CT103A) Clinical Data at ASH 2023 Highlighting Sustained MRD Negativity in Relapsed/Refractory Multiple Myeloma
IASO Biotechnology
Cancer Treatment New Drug Developer
Innovent
High-end Biologics Developer
On December 12, IASO Bio and Innovent Bio jointly announced at the 2023 American Society of Hematology (ASH) Annual MeetingOral ReportFormat showcases the autologous CAR-T therapy targeting BCMA with fully human origin.Equecabtagene Autoleucel InjectionAchieving sustained minimal residual disease (MRD) negativity after treatmentPatients with Multiple MyelomaResearch results on characteristics and efficacy.
Idecabtagene Vicleucel Injection(Innovent Bio R&D code IBI326, IASO Bio R&D code CT103A, English name Equecabtagene Autoleucel, equ-cel)YesAn Innovative CAR-T Candidate Targeting BCMA. The drug has been approved in China this June.Approved for Marketing, used for treatmentAdult patients with relapsed or refractory multiple myeloma.This is also the first one inChinaApproved BCMA-targeted CAR-T products.
The study selected for this year's ASH oral presentation is a post-hoc analysis of the FUMANBA-1 study. The FUMANBA-1 study is a Phase 1b/2, single-arm, multi-center study designed to evaluate the fully human BCMA-targeted CAR-T cell therapy, Ixcellen injection (Innovent Bio), inPatients with relapsed/refractory multiple myeloma (RRMM) who have received 3 or more prior lines of therapyResearch on Efficacy and Safety.
As of December 31, 2022, with a median follow-up time of 18.07 months, deep and sustained responses were observed in 103 evaluable patients. Among the 103 evaluable patients,The overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%.; Among the 91 subjects with no prior history of CAR-T treatment,ORR reached 98.9%, sCR/CR rate reached 82.4%, and the 12-month progression-free survival (PFS) rate was 85.5%.。
MRD-negative rate in the total population was 94.2%, and the MRD-negative rate in patients achieving CR or higher was 100%. The median time to achieve MRD negativity was 15 days, and 80.8% of patients maintained MRD negativity at 12 months post-infusion.。
In addition, Idecabtagene Vicleucel Injection can persist in the body for a relatively long period.The median duration is up to 307.5 days.At 12 months after infusion, 50% of patients had a vector copy number (VCN) above the limit of detection, and at 24 months, 40% of patients still showed persistent detectable VCN.
Based on descriptive analysis, 94.2% of patients treated with Idecabtagene Vicleucel Injection achieved MRD negativity, regardless of whether they had high-risk cytogenetic abnormalities, extramedullary disease, prior lines of therapy, or performance status.This indicates that the killing effect of Ixazomifene Injection as a cellular immunotherapy on myeloma cells is not affected by the above factors.。
In the FUMANBA-1 study, in10-5MRD test results for 90 evaluable RRMM patients without a history of prior CAR-T treatment showed:
Sustained MRD negativity is an important prognostic factor for progression-free survival (PFS) in RRMM patients treated with Idecabtagene Vicleucel Injection:Observation of PFS in patients with different durations of MRD negativity: compared with patients who were MRD-negative for <6 months, those with ≥6 months and ≥12 months of MRD negativity showed significant PFS benefits, especially the group with ≥12 months of MRD negativity.
Correlation between the Persistence of CAR-T Cells and Continuous MRD Negativity after Infusion of Idecabtagene Vicleucel Injection:Overall, there is a positive correlation between the two.Particularly in subgroup analyses, such as the triple-mechanism exposure subgroup, the subgroup with a history of prior autologous transplantation, and the high-risk cytogenetic abnormalities subgroup, the persistence of CAR-T cells (VCN persistence) after infusion of Icaritin injection showed a moderate to strong positive correlation with sustained MRD negativity.In the future, as data further matures, the correlation may become more significant, further suggesting a relationship between the long-term persistence of CAR-T cells and the long-term maintenance of MRD negativity.
The principal investigator of this clinical study, Blood Disease Hospital of Chinese Academy of Medical SciencesProfessor Qi Lu GuiTongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyProfessor Chunrui LiThe study shows that MRD is a biomarker affecting the long-term survival of RRMM patients. Maintaining MRD negativity is essential to improving the prognosis of RRMM patients and extending PF.Idecabtagene Vicleucel Injection Overcomes Two Pain Points of Previous Traditional Therapies in Maintaining MRD-Negative Status: First, it Increases the Proportion of Patients Maintaining MRD-Negativity for 12 Months from Approximately 10% to 80%; Second, Only a Single Infusion is Required to Achieve Sustained MRD-Negativity.Traditional MRD-negative maintenance therapy requires continuous medication, and discontinuation poses a risk of recurrence. Continued treatment pressure without stopping the drug may induce drug-resistant clones to progress to more advanced stages. Long-term medication and complex treatments not only increase direct treatment costs but also significantly impact patients' quality of life due to adverse effects from prolonged treatment, constituting indirect treatment costs and adding economic burdens on patients and their families. With its remarkable long-term persistence in the body, IASO Bio's Ixazomib injection enables RRMM patients who have failed multiple lines of treatment to achieve durable and deep remission. It is hoped that it will bring the hope of a cure to more patients.
References:
