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Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography
Published on: February 17, 2022
Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
Nikhil C Munshi1, Larry D Anderson1, Nina Shah1
1From the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute (N.C.M.), the Veterans Affairs Boston Healthcare System, Harvard Medical School (N.C.M.), and Massachusetts General Hospital (N.R.), Boston, and bluebird bio, Cambridge (F.P., M.M.) - all in Massachusetts; Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas (L.D.A.); the University of California, San Francisco, San Francisco (N.S.); Icahn School of Medicine at Mount Sinai, New York (D.M.); Sarah Cannon Research Institute and Tennessee Oncology, Nashville (J.B.); Emory School of Medicine, Atlanta (S.L.); Mayo Clinic, Rochester, MN (Y.L.); Hackensack University Medical Center, Hackensack (D.S.), and Bristol-Myers Squibb, Princeton (J.N.C., S.K., P.P., L.H., T.B.C., K.H.) - both in New Jersey; Institut Josep Carreras and Institut Catala d'Oncologia, Hospital Germans Trias i Pujol, Badalona (A.O.), and Clinica Universidad de Navarra, Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona (J.S.-M.) - both in Spain; Centre Hospitalier Universitaire (CHU) de Nantes, Nantes (P.M.), and CHU de Lille, University of Lille, INSERM Unité 1286, Institute for Translational Research in Inflammation, Lille (I.Y.-A.) - both in France; University Hospital Leuven, Leuven, Belgium (M.D.); "Seràgnoli" Institute of Hematology, Bologna University School of Medicine, Bologna (M.C.), the Department of Oncology and Hematology, University of Milan, Milan (A.R.), and Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo (A.R.) - all in Italy; University Hospital of Würzburg, Würzburg (H.E.), University Hospital Heidelberg (H.G.) and the National Center for Tumor Diseases (H.G.), Heidelberg, the University Medical Center Hamburg-Eppendorf, Hamburg (K.W.), and Universitätsklinikum Tübingen, Tübingen (K.W.) - all in Germany; and Princess Margaret Cancer Centre, Toronto (D.R.).
Idecabtagene vicleucel (ide-cel) demonstrated significant clinical activity in patients with relapsed and refractory multiple myeloma, achieving responses in 73% of treated individuals. The CAR T-cell therapy showed notable efficacy, with 26% achieving minimal residual disease-negative status.
Area of Science:
- Oncology
- Immunotherapy
- Hematology
Background:
- Idecabtagene vicleucel (ide-cel) is a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy.
- It has demonstrated clinical activity in relapsed and refractory multiple myeloma, with expected CAR T-cell toxic effects.
Purpose of the Study:
- To confirm the efficacy and safety of ide-cel in patients with relapsed and refractory multiple myeloma.
- To evaluate response rates, including overall response and complete response, and minimal residual disease (MRD) negativity.
Main Methods:
- Phase 2 study enrolling 140 patients with multiple myeloma after at least three prior regimens.
- Patients received ide-cel at target doses ranging from 150 × 10^6 to 450 × 10^6 CAR-positive T cells.
- Primary endpoint: overall response; Key secondary endpoint: complete response or better.
Main Results:
- Of 128 treated patients, 73% achieved an overall response, and 33% achieved a complete response or better.
- Minimal residual disease (MRD)-negative status was confirmed in 26% of treated patients.
- Median progression-free survival was 8.8 months; common toxicities included neutropenia (91%), anemia (70%), thrombocytopenia (63%), and cytokine release syndrome (84%).
Conclusions:
- Ide-cel induces responses in a majority of heavily pretreated patients with relapsed and refractory multiple myeloma.
- MRD-negative status was achieved in 26% of treated patients.
- Grade 3 or 4 toxic effects were common, primarily hematologic toxic effects and cytokine release syndrome.
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