Standard-of-care idecabtagene vicleucel for relapsed/refractory multiple myeloma
Abstract
Abstract Idecabtagene vicleucel (ide-cel) was the first US Food and Drug Administration–approved chimeric antigen receptor T-cell (CAR-T) therapy for multiple myeloma (MM). However, because clinical trials are highly selective with stringent eligibility criteria, the objective of this study was to evaluate the safety and effectiveness of standard-of-care (SOC) ide-cel in the real world. Using the Center for International Blood and Marrow Transplant Research registry, we evaluated 821 patients who received SOC ide-cel. Median follow-up was 11.6 months. Median age was 66 years, and the cohort included 31% patients aged ≥70 years, with 15% Black and 7% Hispanic, and 77% of patients with ≥1 significant comorbidity. The median number of prior lines of therapy was 7, 15% patients previously received B-cell maturation antigen–directed therapy, 17% had extramedullary disease, and 27% had high-risk cytogenetics. Overall response rate was 73%, and complete response rate was 25%. Median progression-free survival was 8.8 months. Treatment-related mortality was reported in 6% of patients. Cytokine release syndrome was diagnosed in 80% of patients (grade ≥3, 3%). Immune effector cell–associated neurotoxicity syndrome was observed in 28% (grade ≥3, 5%), with no cases of Parkinsonism reported. Clinically significant infections were seen in 45% of patients. Second primary malignancies were reported in 4%, including 1% myeloid malignancies. This is, to our knowledge, the largest real-world study of ide-cel CAR-T therapy in patients with relapsed/refractory (R/R) MM. We observed a favorable safety and efficacy profile that mirrors trial experience, even in the setting of significant comorbidities in 77% of patients, many of which would have made them ineligible for the registrational KarMMa clinical trial. This trial was registered at www.clinicaltrials.gov as #NCT03361748.
Article Details
Authors (26)
Surbhi Sidana
Stanford University School of Medicine, Palo Alto, CA
Nausheen Ahmed
5University of Kansas Health System, Division of Hematological Malignancy and Cellular Therapeutics, Kansas City, United States
Othman Salim Akhtar
3Department of Medicine, Medical College of Wisconsin, Milwaukee, WI
Ruta Brazauskas
Medical College of Wisconsin, Milwaukee, WI
Temitope Oloyede
1Medical College of Wisconsin, Milwaukee, United States
Matthew Bye
4Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI
Doris Hansen
1H. Lee Moffitt Cancer Center and Research Institute, Tampa, United States
Christopher Ferreri
7Atrium Health Levine Cancer Institute, Charlotte, United States
Ciara L. Freeman
7Department of Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Aimaz Afrough
Myeloma, Waldenstrom’s, and Amyloidosis Program, Hematologic Malignancies and Cellular Therapy Program, Simmons Comprehensive Cancer Center (A.A.), University of Texas Southwestern Medical Center, Dallas, TX.
Larry D. Anderson
1Myeloma, Waldenstrom’s, and Amyloidosis Program, Section of Hematologic Malignancies and Cellular Therapy, Simmons Comprehensive Cancer Center, The University of Texas Southwestern Medical Center, Dallas, TX
Binod Dhakal
2Division of Hematology/Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI
Devender Dhanda
8Bristol Myers Squibb, Princeton, United States
Lohith Gowda
Hamza Hashmi
Memorial Sloan Kettering Cancer Center, New York
Melanie J. Harrison
9Bristol Myers Squibb, Summit, NJ
Amani Kitali
9Bristol Myers Squibb, Summit, NJ
Heather Landau
Adult Bone Marrow Transplantation Service Memorial Sloan Kettering Cancer Center New York New York USA
Abu-Sayeef Mirza
6Moffitt Cancer Center, Tampa, FL
Pallavi Patwardhan
9Bristol Myers Squibb, Summit, NJ
Muzaffar Qazilbash
1MD Anderson Cancer Center, Department of Stem Cell Transplantation and Cellular Therapy, Houston, United States
Saad Usmani
8Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
Krina Patel
4The University of Texas MD Anderson Cancer Center, Houston, United States
Taiga Nishihori
Moffitt Cancer Center, Tampa, Florida, United States
Siddhartha Ganguly
6Houston Methodist Hospital, Houston, United States
Marcelo C. Pasquini
18Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI