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Nikhil C. Munshi, Larry Don Anderson, Nina D. Shah, Deepu Madduri, Jesús G. Berdeja, Sagar Lonial, Noopur S Raje, Yi Lin, David Samuel DiCapua Siegel, Albert Oriol and 18 more
BACKGROUNDIdecabtagene vicleucel (ide-cel, also called bb2121), a B-cell maturation antigendirected chimeric antigen receptor (CAR) T-cell therapy, has shown clinical activity with expected CAR T-cell toxic effects in patients with relapsed and refractory multiple myeloma. METHODSIn this phase 2 study, we sought to confirm the efficacy and safety of ide-cel in patients with relapsed and refractory myeloma.Patients with disease after at least three previous regimens including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody were enrolled.Patients received ide-cel target doses of 150 × 10 6 to 450 × 10 6 CAR-positive (CAR+) T cells.The primary end point was an overall response (partial response or better); a key secondary end point was a complete response or better (comprising complete and stringent complete responses). RESULTSOf 140 patients enrolled, 128 received ide-cel.At a median follow-up of 13.3 months, 94 of 128 patients (73%) had a response, and 42 of 128 (33%) had a complete response or better.Minimal residual disease (MRD)-negative status (<10 -5 nucleated cells) was confirmed in 33 patients, representing 26% of all 128 patients who were treated and 79% of the 42 patients who had a complete response or better.The median progression-free survival was 8.8 months (95% confidence interval, 5.6 to 11.6).Common toxic effects among the 128 treated patients included neutropenia in 117 patients (91%), anemia in 89 (70%), and thrombocytopenia in 81 (63%).Cytokine release syndrome was reported in 107 patients (84%), including 7 (5%) who had events of grade 3 or higher.Neurotoxic effects developed in 23 patients (18%) and were of grade 3 in 4 patients (3%); no neurotoxic effects higher than grade 3 occurred.Cellular kinetic analysis confirmed CAR+ T cells in 29 of 49 patients (59%) at 6 months and 4 of 11 patients (36%) at 12 months after infusion. CONCLUSIONSIde-cel induced responses in a majority of heavily pretreated patients with refractory and relapsed myeloma; MRD-negative status was achieved in 26% of treated patients.Almost all patients had grade 3 or 4 toxic effects, most commonly hematologic toxic effects and cytokine release syndrome.(Funded by bluebird bio and Celgene, a Bristol-Myers Squibb company; KarMMa ClinicalTrials.govnumber, NCT03361748.
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Munshi, N. C., Anderson, L. D., Shah, N. D., Madduri, D., Berdeja, J. G., Lonial, S., Raje, N. S., Lin, Y., Siegel, D. S. D., Oriol, A., Moreau, P., Yakoub‐Agha, I., Delforge, M., Cavo, M., Einsele, H., Goldschmidt, H., Weisel, K. C., Rambaldi, A., Reece, D. E., … Miguel, J. F. S. (2021). Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. New England Journal of Medicine, 384(8), 705–716. https://doi.org/10.1056/nejmoa2024850
Munshi, Nikhil C., et al. "Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma." New England Journal of Medicine, vol. 384, no. 8, 2021, pp. 705–716, https://doi.org/10.1056/nejmoa2024850.
Munshi, Nikhil C., Larry Don Anderson, Nina D. Shah, Deepu Madduri, Jesús G. Berdeja, Sagar Lonial, Noopur S Raje, et al. "Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma." New England Journal of Medicine 384, no. 8 (2021): 705–716. https://doi.org/10.1056/nejmoa2024850.
Munshi N. C., Anderson L. D., Shah N. D. [и др.] Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma // New England Journal of Medicine. — 2021. — Vol. 384, № 8. — P. 705–716. — URL: https://doi.org/10.1056/nejmoa2024850
@article{munshi2021idecabtagene,
title = {{Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma}},
author = {Nikhil C. Munshi and Larry Don Anderson and Nina D. Shah and Deepu Madduri and Jesús G. Berdeja and Sagar Lonial and Noopur S Raje and Yi Lin and David Samuel DiCapua Siegel and Albert Oriol and Philippe Moreau and Ibrahim Yakoub‐Agha and Michel Delforge and Michèle Cavo and Hermann Einsele and Hartmut Goldschmidt and Katja Christina Weisel and Alessandro Rambaldi and Donna Ellen Reece and Fabio Petrocca and Monica Massaro and Jamie N. Connarn and Shari M. Kaiser and Payal J. Patel and Liping Huang and Timothy Campbell and Kristen M. Hege and Jesús F. San Miguel},
journal = {New England Journal of Medicine},
year = {2021},
volume = {384},
number = {8},
pages = {705--716},
doi = {10.1056/nejmoa2024850},
url = {https://doi.org/10.1056/nejmoa2024850}
}TY - JOUR AU - Munshi, Nikhil C. AU - Anderson, Larry Don AU - Shah, Nina D. AU - Madduri, Deepu AU - Berdeja, Jesús G. AU - Lonial, Sagar AU - Raje, Noopur S AU - Lin, Yi AU - Siegel, David Samuel DiCapua AU - Oriol, Albert AU - Moreau, Philippe AU - Yakoub‐Agha, Ibrahim AU - Delforge, Michel AU - Cavo, Michèle AU - Einsele, Hermann AU - Goldschmidt, Hartmut AU - Weisel, Katja Christina AU - Rambaldi, Alessandro AU - Reece, Donna Ellen AU - Petrocca, Fabio AU - Massaro, Monica AU - Connarn, Jamie N. AU - Kaiser, Shari M. AU - Patel, Payal J. AU - Huang, Liping AU - Campbell, Timothy AU - Hege, Kristen M. AU - Miguel, Jesús F. San TI - Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma JO - New England Journal of Medicine VL - 384 IS - 8 SP - 705 EP - 716 PY - 2021 DA - 2021/02/24 DO - 10.1056/nejmoa2024850 UR - https://doi.org/10.1056/nejmoa2024850 ER -
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