denotes an abstract that is clinically relevant.
denotes that this is a recommended PHD Trainee Session.
denotes that this is a ticketed session.Session: 652. Multiple Myeloma: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Research, Biological therapies, Clinical Research, Plasma Cell Disorders, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Diseases, real-world evidence, Therapies, Lymphoid Malignancies
Chimeric antigen receptor modified T-cell therapy is a promising new treatment for patients
with heavily pre-treated multiple myeloma (MM). BCMA (B-cell maturation antigen) directed
therapies including idecabtagene vicleucel (Ide-Cel) and ciltacabtagene autoleucel (Cilta-Cel) are
currently approved for use in patients with four prior lines of therapy. Both therapies have
shown efficacy producing a high overall response rates and durable responses. Both are second-generation designs with identical
endodomain (CD3ζ – 4-1BB) to target BCMA on the target cells for patients with relapsed and
refractory MM who have been triple-class exposed. The two distinct differences are ectodomain
structure and recommended dose. In this single center retrospective study, we report our
experience with the use of both CAR-T therapies in patients with heavily pre-treated MM.
Methods
Following institutional review board approval, we included all patients with MM who were
treated with commercially approved BCMA directed CAR-T therapy. Demographic
characteristics, molecular studies, treatment and response information were recorded and
included in the study. Safety outcomes included the incidence and severity of adverse events
(AEs). AEs were graded using National Cancer Institute Common Terminology Criteria for
Adverse Events version 5.0 (NCI-CTCAE 5.0). Cytokine release syndrome (CRS) and immune
effector associated neurotoxicity syndrome (ICANS) were graded as per the American Society
for Transplantation and Cellular Therapy criteria. Efficacy outcomes included overall response
rates (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR).
Survival analysis was performed using the Kaplan-Meier method including PFS and Overall
survival (OS). PFS was defined as time from initiation of treatment to progression of disease or
death whichever occurred first. OS was defined as time from initiation of treatment to death. The
IMW response criteria was utilized for response assessment.
Results
We identified 56 patients who were treated consecutively at Hackensack University Medical
Center between 6/28/2021 and 7/3/2023. 53 patients had data available for evaluable responses
and were included in our analysis. 35(66%) patients received Ide-cel, whereas 18(34%) patients
received Cilta-Cel. For the entire cohort, 30(56.6%) were male, median age was 69.6 years,
median time from diagnosis to treatment was 8.1 years. Patients had received a median of 5 prior
lines of therapy. 50(94.3%) patients were triple class refractory, all except one patient (98.1%) had a prior autologous stem cell transplant (ASCT). 27(60%) patients had high risk FISH defined
as those with t(4;14), t(14;16), 17p(-) or 1q(+), 24(60%) patients were ISS-2 or 3 at diagnosis.
Treatment was overall well tolerated, with only one therapy related mortality, 42(79.3%) patients
experienced CRS, with only 1(1.9%) having grade 3 or higher CRS. 6(11.3%) patients
experienced ICANS, with 2(3.8%) having grade 3 or higher ICANS. Baseline characteristics are
summarized in table 1. Overall response rate for the entire cohort was 75.4%, with a median PFS
of 11.9 months, median DOR of 13.2 months and mOS was not reached (NR). The median ORR
for cilta-cel vs ide-cel was 94.4 % and 65.7% (p=0.01) respectively. The median PFS for cilta-
cel vs ide-cel was NR vs 10.9 months (p=0.09) respectively (Figure 1), follow-up being very short for cilta-
cel. Baseline characteristics, safety and efficacy data for the cohort and comparison between the two therapies are summarized in table 1.
Conclusions
In our single center experience, cilta-cel has shown superiority in terms of efficacy compared to
ide-cel. Having said that, the authors do strongly recognize that longer manufacturing time for
cilta-cel introduces a bias in favor of using ide-cel for patients with more aggressive/rapidly
progressing disease, which may therefore result in inferior outcomes. The safety profile for both therapies is very similar and both offer promising results to patients with MM.
Disclosures: Biran: Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharm: Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Research Funding; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Honoraria; Genomic Testing Cooperative: Divested equity in a private or publicly-traded company in the past 24 months; GSK: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Boehringer Ingelheim: Other: spouse of employee. Siegel: Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celularity Scientific: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Karyopharm: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Parmar: Sanofi: Consultancy, Honoraria; Cellectar Biosciences: Consultancy, Honoraria.
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