Safety and efficacy of standard-of-care ciltacabtagene autoleucel for relapsed/refractory multiple myeloma
Abstract
Abstract Ciltacabtagene autoleucel (cilta-cel) was approved in 2022 for patients with relapsed/refractory multiple myeloma (RRMM). We report outcomes with cilta-cel in the standard-of-care setting. Patients with RRMM who underwent leukapheresis for cilta-cel manufacturing between 1 March 2022 and 31 December 2022 at 16 US academic medical centers were included. Overall, 255 patients underwent leukapheresis and 236 (92.5%) received cilta-cel, of which 54% would not have met CARTITUDE-1 eligibility criteria. In treated patients (N = 236), cytokine release syndrome was seen in 75% (grade ≥3, 5%), immune effector cell–associated neurotoxicity syndrome in 14% (grade ≥3, 4%), and delayed neurotoxicity in 10%. Overall and complete response rates were as follows: all patients who received cilta-cel (N = 236), 89% and 70%; patients receiving conforming cilta-cel (n = 191), 94% and 74%; and conforming cilta-cel with fludarabine/cyclophosphamide lymphodepletion (n = 152), 95% and 76%, respectively. Nonrelapse mortality was 10%, most commonly from infection. After a median follow-up of 13 months from cilta-cel, the median progression-free survival (PFS) was not reached, with 12-month estimate being 68% (95% confidence interval, 62-74). High ferritin levels, high-risk cytogenetics, and extramedullary disease were independently associated with inferior PFS, with a signal for prior B-cell maturation antigen–targeted therapy (P = .08). Second primary malignancies excluding nonmelanoma skin cancers were seen in 5.5% and myeloid malignancies/acute leukemia in 1.7%. We observed a favorable efficacy profile of standard-of-care cilta-cel in RRMM, despite more than half the patients not meeting the CARTITUDE-1 eligibility criteria.
Article Details
Authors (38)
Surbhi Sidana
Stanford University School of Medicine, Palo Alto, CA
Krina K. Patel
The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
Lauren C. Peres
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Radhika Bansal
4Division of Hematology, Mayo Clinic, Rochester, MN
Mehmet H. Kocoglu
Leyla Shune
Shebli Atrash
Levine Cancer Institute–Atrium Health, Charlotte, NC
Kinaya Smith
4Medical College of Wisconsin, Milwaukee, United States
Shonali Midha
13Dana-Farber Cancer Institute, Boston, United States
Christopher Ferreri
7Atrium Health Levine Cancer Institute, Charlotte, United States
Binod Dhakal
2Division of Hematology/Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI
Danai Dima
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Patrick Costello
9Division of Hematology, Dana-Farber Cancer Institute, Boston, MA
Charlotte Wagner
Ran Reshef
13Division of Hematology/Oncology, Blood and Marrow Transplantation and Cell Therapy Program, Columbia University Irving Medical Center, New York, NY
Hitomi Hosoya
Lekha Mikkilineni
Stanford University School of Medicine, Palo Alto, California, United States
Djordje Atanackovic
Saurabh Chhabra
6The Mayo Clinic Arizona, Pheonix, United States
Ricardo Parrondo
2Mayo Clinic, Jacksonville, United States
Omar Nadeem
Hashim Mann
2Virginia Commonwealth University, Hematology, Oncology & Palliative Care, Richmond, United States
Nilesh Kalariya
4The University of Texas MD Anderson Cancer Center, Houston, United States
Vanna Hovanky
Gabriel De Avila
H Lee Moffitt Cancer Center, Tampa, Florida, United States
Ciara L. Freeman
7Department of Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Frederick L. Locke
Melissa Alsina
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Sandy Wong
10Bristol Myers Squibb, Princeton, United States
Megan Herr
15Roswell Park Comprehensive Cancer Center, Buffalo, United States
Myo Htut
City of Hope, Duarte, California, United States
Joseph McGuirk
2The Mikael Rayaan Foundation Global Research Training Institute (MRF GRTI), Kansas City, United States
Douglas W. Sborov
5Huntsman Cancer Institute, The University of Utah, Salt Lake City, UT
Jack Khouri
1Cleveland Clinic Foundation, Department of Hematology and Medical Oncology, Cleveland, United States
Thomas Martin
16Department of Hematology, University of California at San Francisco, San Francisco, CA
Murali Janakiram
10City of Hope, Duarte, United States
Yi Lin
Doris K. Hansen
1Department of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL