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. 2023 Apr 10;41(11):2087-2097.
doi: 10.1200/JCO.22.01365. Epub 2023 Jan 9.

Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma: Real-World Experience From the Myeloma CAR T Consortium

Doris K Hansen  1 , Surbhi Sidana  2 , Lauren C Peres  1 , Christelle Colin Leitzinger  1 , Leyla Shune  3 , Alexandria Shrewsbury  1 , Rebecca Gonzalez  1 , Douglas W Sborov  4 , Charlotte Wagner  4 , Danai Dima  5 , Hamza Hashmi  6 , Mehmet H Kocoglu  7 , Shebli Atrash  8 , Gary Simmons  9 , Nilesh Kalariya  10 , Christopher Ferreri  10 , Aimaz Afrough  11 , Ankit Kansagra  11 , Peter Voorhees  8 , Rachid Baz  1 , Jack Khouri  5 , Melissa Alsina  1 , Joseph McGuirk  3 , Frederick L Locke  1 , Krina K Patel  10
Affiliations

Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma: Real-World Experience From the Myeloma CAR T Consortium

Doris K Hansen et al. J Clin Oncol. .

Abstract

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.

Methods: Data 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.

Results: One 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.

Conclusion: The 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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Conflict of interest statement

Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma: Real-World Experience from the Myeloma CAR T Consortium

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Figures

FIG 1.
FIG 1.
Flow diagram. CAR, chimeric antigen receptor; ide-cel, idecabtagene vicleucel.
FIG 2.
FIG 2.
Tumor responses, DOR, PFS, and OS estimates. (A) Day 30, day 90, and best overall tumor responses. (B) PFS from ide-cel infusion. (C) OS from ide-cel infusion. (D) DOR in ide-cel responders. CR, complete response; DOR, Duration of response; ide-cel, idecabtagene vicleucel; MRD, minimal residual disease; NR, not reached; OS, overall survival; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.
FIG 3.
FIG 3.
PFS and OS estimates by prior BCMA exposure. (A) PFS by any prior BCMA-TT. (B) OS by any prior BCMA-TT. (C) PFS by prior belantamab mafodotin. (D) PFS by BCMA bispecific T-cell recruiting antibody on clinical trial. (E) PFS by prior BCMA CAR T on clinical trial. (F) Tumor responses by any prior BCMA-TT. BCMA, B-cell maturation antigen; CAR, chimeric antigen receptor; CR, complete response; MRD, minimal residual disease; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; TT, targeted therapy; VGPR, very good partial response.
FIG A1.
FIG A1.
(A) PFS and (B) OS by high-risk cytogenetics. NR, not reached; OS, overall survival; PFS, progression-free survival.
FIG A2.
FIG A2.
(A) PFS and (B) OS by presence or absence of KarMMa exclusion criteria. NR, not reached; OS, overall survival; PFS, progression-free survival.
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Comment in

References

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