Idecabtagene vicleucel (Ide-cel) chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory multiple myeloma (RRMM): Real-world experience.

Authors

null

Doris K. Hansen

H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL

Doris K. Hansen , Surbhi Sidana , Lauren Peres , Leyla Shune , Douglas W. Sborov , Hamza Hashmi , Mehmet H. Kocoglu , Shebli Atrash , Gary Simmons , Nilesh Kalariya , Christopher J. Ferreri , Aimaz Afrough , Ankit J. Kansagra , Peter M. Voorhees , Melissa Alsina , Joseph McGuirk , Frederick L. Locke , Krina K. Patel

Organizations

H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, Stanford University, Stanford, CA, The University of Kansas Cancer Center, Kansas City, KS, The University of Utah Huntsman Cancer Institute, Salt Lake City, UT, Medical University of South Carolina, Charleston, SC, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, MD, Levine Cancer Institute, Charlotte, NC, Virginia Commonwealth University Massey Cancer Center, Richmond, VA, The University of Texas MD Anderson Cancer Center, Houston, TX, UT Southwestern Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, The University of Texas MD Anderson Cancer Center, Department of Lymphoma/Myeloma, Houston, TX

Research Funding

No funding received

Background: Ide-cel, a BCMA directed CAR T-cell therapy, was FDA approved 3/26/2021 for the treatment of RRMM after 4 prior lines of therapy. We evaluated the real-world outcomes of patients treated with standard of care ide-cel under the commercial FDA label. Methods: Ten US academic centers contributed data to this effort independent of the manufacturer. As of 1/10/2022, 138 patients were leukapheresed with overall manufacturing failure in 6 (4%). 108 patients were infused ≥ 30 days prior to data-cut off and constitute the study population for this retrospective analysis. Results: Table describes the study population compared to the pivotal KarMMa-1 trial (Munshi et al, NEJM 2021). Patients in our study were less likely to have ECOG PS of 0/1 (77%) and more likely to be penta-refractory (41%). 67% of patients would not have met eligibility criteria for KarMMa. Common reasons for ineligibility (> 1 reason in 22% patients) were co-morbidities (28%), cytopenias (22%), prior therapy with alloSCT/CAR-T/other BCMA therapy (19%), CNS myeloma/non-measurable disease/plasma cell leukemia (13%), and fitness (12%). 81% of patients received bridging therapy. Toxicity was comparable to that seen in KarMMa-1. Cytokine release syndrome (CRS) was seen in 82% (> grade 3: 4%) and immune effector cell-associated neurotoxicity syndrome (ICANS) in 15% (> grade 3: 5%) of patients, respectively. Tocilizumab and steroids were used in 72% and 25% of patients, respectively. Infections were seen in 34% of patients. Day 30 response was evaluable in 104 patients. Response rates were: ≥ partial response, 83%; ≥ very good partial response, 64%; and ≥ complete response (CR), 34%. 11% of patients have died by data cut-off, 7 due to disease progression and 5 due to other causes (1 grade 5 CRS, 1 hemophagocytic lymphohistiocytosis, 1 progressive neurological weakness, 2 COVID-19). Conclusions: This multicenter retrospective study delineates the real-world outcomes of ide-cel CAR T-cell therapy for RRMM. Despite more patients being penta-refractory and less fit compared to the pivotal KarMMa trial, safety and 30-day responses in the real-world setting (overall response rate: 83%, CR: 34%) are comparable to the clinical trial population. Follow-up is ongoing and updated data will be presented.

Patient characteristics and outcomes: Comparison between KarMMa-1 (Munshi et al. NEJM 2021) and commercial standard of care ide-cel treatment at 10 U.S. centers.


KarMMa-1, N=128
Real world, N=108
Median age, yrs
61 (33-78)
64 (36-78)
ECOG PS 0 or 1
98%
77%
Extramedullary disease
39%
53%
High-risk cytogenetics
35%
33%
Median prior regimens
6
6
Prior autologous transplant
94%
85%
Penta-refractory disease
26%
41%
ORR/CR
73%/33% (Best response)
83%/34% (Day 30)
Grade ≥ 3 CRS and ICANS
5%, 3%
5%, 5%

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Plasma Cell Dyscrasia

Track

Hematologic Malignancies

Sub Track

Multiple Myeloma

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 8042)

DOI

10.1200/JCO.2022.40.16_suppl.8042

Abstract #

8042

Poster Bd #

466

Abstract Disclosures