TY - JOUR
T1 - Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma
T2 - Real-World Experience from the Myeloma CAR T Consortium
AU - Hansen, Doris K.
AU - Sidana, Surbhi
AU - Peres, Lauren C.
AU - Colin Leitzinger, Christelle
AU - Shune, Leyla
AU - Shrewsbury, Alexandria
AU - Gonzalez, Rebecca
AU - Sborov, Douglas W.
AU - Wagner, Charlotte
AU - Dima, Danai
AU - Hashmi, Hamza
AU - Kocoglu, Mehmet H.
AU - Atrash, Shebli
AU - Simmons, Gary
AU - Kalariya, Nilesh
AU - Ferreri, Christopher
AU - Afrough, Aimaz
AU - Kansagra, Ankit
AU - Voorhees, Peter
AU - Baz, Rachid
AU - Khouri, Jack
AU - Alsina, Melissa
AU - McGuirk, Joseph
AU - Locke, Frederick L.
AU - Patel, Krina K.
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/4/10
Y1 - 2023/4/10
N2 - PURPOSE Idecabtagene vicleucel (ide-cel) is an autologous B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy approved for relapsed/refractory multiple myeloma (RRMM) on the basis of the phase II pivotal KarMMa trial, which demonstrated best overall and ≥ complete response rates of 73% and 33%, respectively. We report clinical outcomes with standard-of-care (SOC) ide-cel under the commercial Food and Drug Administration label.METHODSData were retrospectively collected from patients with RRMM who underwent leukapheresis as of February 28, 2022, at 11 US institutions with intent to receive SOC ide-cel. Toxicities were graded per American Society for Transplantation and Cellular Therapy guidelines and managed according to each institution's policies. Responses were graded on the basis of the International Myeloma Working Group response criteria.RESULTSOne hundred fifty-nine of 196 leukapheresed patients received ide-cel by data cutoff. One hundred twenty (75%) infused patients would have been ineligible for participation in the KarMMa clinical trial because of comorbidities at the time of leukapheresis. Any grade and grade ≥ 3 cytokine release syndrome and neurotoxicity occurred in 82/3% and 18/6%, respectively. Best overall and ≥ complete response rates were 84% and 42%, respectively. At a median follow-up of 6.1 months from chimeric antigen receptor T infusion, the median progression-free survival was 8.5 months (95% CI, 6.5 to not reached) and the median overall survival was 12.5 months (95% CI, 11.3 to not reached). Patients with previous exposure to B-cell maturation antigen-targeted therapy, high-risk cytogenetics, Eastern Cooperative Oncology Group performance status ≥ 2 at lymphodepletion, and younger age had inferior progression-free survival on multivariable analysis.CONCLUSIONThe safety and efficacy of ide-cel in patients with RRMM in the SOC setting were comparable with those in the phase II pivotal KarMMa trial despite most patients (75%) not meeting trial eligibility criteria.
AB - PURPOSE Idecabtagene vicleucel (ide-cel) is an autologous B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy approved for relapsed/refractory multiple myeloma (RRMM) on the basis of the phase II pivotal KarMMa trial, which demonstrated best overall and ≥ complete response rates of 73% and 33%, respectively. We report clinical outcomes with standard-of-care (SOC) ide-cel under the commercial Food and Drug Administration label.METHODSData were retrospectively collected from patients with RRMM who underwent leukapheresis as of February 28, 2022, at 11 US institutions with intent to receive SOC ide-cel. Toxicities were graded per American Society for Transplantation and Cellular Therapy guidelines and managed according to each institution's policies. Responses were graded on the basis of the International Myeloma Working Group response criteria.RESULTSOne hundred fifty-nine of 196 leukapheresed patients received ide-cel by data cutoff. One hundred twenty (75%) infused patients would have been ineligible for participation in the KarMMa clinical trial because of comorbidities at the time of leukapheresis. Any grade and grade ≥ 3 cytokine release syndrome and neurotoxicity occurred in 82/3% and 18/6%, respectively. Best overall and ≥ complete response rates were 84% and 42%, respectively. At a median follow-up of 6.1 months from chimeric antigen receptor T infusion, the median progression-free survival was 8.5 months (95% CI, 6.5 to not reached) and the median overall survival was 12.5 months (95% CI, 11.3 to not reached). Patients with previous exposure to B-cell maturation antigen-targeted therapy, high-risk cytogenetics, Eastern Cooperative Oncology Group performance status ≥ 2 at lymphodepletion, and younger age had inferior progression-free survival on multivariable analysis.CONCLUSIONThe safety and efficacy of ide-cel in patients with RRMM in the SOC setting were comparable with those in the phase II pivotal KarMMa trial despite most patients (75%) not meeting trial eligibility criteria.
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U2 - 10.1200/JCO.22.01365
DO - 10.1200/JCO.22.01365
M3 - Article
C2 - 36623248
AN - SCOPUS:85148978995
SN - 0732-183X
VL - 41
SP - 2087
EP - 2097
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 11
ER -