3,056
Views
0
CrossRef citations to date
0
Altmetric
Drug Evaluation

Cilta-cel, a BCMA-targeting CAR-T therapy for heavily pretreated patients with relapsed/refractory multiple myeloma

, , & ORCID Icon
Pages 2297-2311 | Received 28 Dec 2022, Accepted 21 Jun 2023, Published online: 27 Jul 2023

References

  • Rajkumar SV , KumarS. Multiple myeloma current treatment algorithms. Blood Cancer J10(9), 94 (2020).
  • NCCN clinical practice guidelines in oncology: multiple myeloma ver5.2022. https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1445 (Accessed 10102022).
  • Durer C , DurerS, LeeSet al. Treatment of relapsed multiple myeloma: evidence-based recommendations. Blood Rev.39, 100616 (2020).
  • Shimazu Y , MizunoS, FuchidaSIet al. Improved survival of multiple myeloma patients treated with autologous transplantation in the modern era of new medicine. Cancer Sci112(12), 5034–5045 (2021).
  • Fonseca R , UsmaniSZ, MehraMet al. Frontline treatment patterns and attrition rates by subsequent lines of therapy in patients with newly diagnosed multiple myeloma. BMC Cancer20(1), 1087 (2020).
  • Gandhi UH , CornellRF, LakshmanAet al. Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy. Leukemia33(9), 2266–2275 (2019).
  • Mateos MV , WeiselK, DeStefano Vet al. LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma. Leukemia36(5), 1371–1376 (2022).
  • Cho SF , AndersonKC, TaiYT. Targeting B cell maturation antigen (BCMA) in multiple myeloma: potential uses of BCMA-based immunotherapy. Front Immunol9, 1821 (2018).
  • Berdeja JG , MadduriD, UsmaniSZet al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase Ib/2 open-label study. Lancet398(10297), 314–324 (2021).
  • Munshi NC , AndersonLDJr, ShahNet al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N. Engl. J. Med.384(8), 705–716 (2021).
  • Lonial S , LeeHC, BadrosAet al. Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Cancer127(22), 4198–4212 (2021).
  • Chari A , VoglDT, GavriatopoulouMet al. Oral selinexor-dexamethasone for triple-class refractory multiple myeloma. N. Engl. J. Med.381(8), 727–738 (2019).
  • Moreau P , GarfallAL, vande Donk Net al. Teclistamab in relapsed or refractory multiple myeloma. N. Engl. J. Med.387(6), 495–505 (2022).
  • Martin T , UsmaniSZ, BerdejaJGet al. Ciltacabtagene autoleucel, an anti-B-cell maturation antigen chimeric antigen receptor T-cell therapy, for relapsed/refractory multiple myeloma: CARTITUDE-1 2 years follow-up. J. Clin. Oncol.41(6), 1265–1274 (2023).
  • Anderson LD Jr , MunshiN, ShahNet al. Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T therapy, in relapsed and refractory multiple myeloma: updated KarMMa results. J. Clin. Oncol.39, 8016 (2021).
  • Celgene Corporation, a Bristol-Myers Squibb Company: ABECMA® (idecabtagene vicleucel) prescribing information). https://packageinserts.bms.com/pi/ (Accessed 10102022).
  • Bristol-Myers Squibb Pharma: ABECMA® (idecabtagene vicleucel) Summary of Product Characteristics). https://www.ema.europa.eu/en/documents/product-information/abecma-epar-product-information_en.pdf (Accessed 10102022).
  • Janssen Biotech, Inc and Legend Biotech: CARVYKTI® (ciltacabtagene autoleucel) prescribing information). https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf (Accessed 10102022).
  • Rodriguez-Otero P , AilawadhiS, ArnulfBet al. Ide-cel or standard regimens in relapsed and refractory multiple myeloma. N. Engl. J. Med.388(11), 1002–1014 (2023).
  • Janssen Biotech, Inc and Legend Biotech: CARVYKTI® (ciltacabtagene autoleucel) Summary of Product Characteristics). https://www.ema.europa.eu/en/documents/product-information/carvykti-epar-product-information_en.pdf (Accessed 10102022).
  • Zhao WH , WangBY, ChenLJet al. Four-year follow-up of LCAR-B38M in relapsed or refractory multiple myeloma: a phase I, single-arm, open-label, multicenter study in China (LEGEND-2). J Hematol Oncol15(1), 86 (2022).
  • Usmani SZ , BerdejaJ, MadduriDet al. Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): updated results from CARTITUDE-1. J. Clin. Oncol.39, 8005 (2021).
  • Martin T , KrishnanA, YongKet al. Comparative effectiveness of ciltacabtagene autoleucel in CARTITUDE-1 versus physician’s choice of therapy in the Flatiron Health multiple myeloma cohort registry for the treatment of patients with relapsed or refractory multiple myeloma. eJHaem3, 97–108 (2022).
  • Costa LJ , LinY, CornellRFet al. Comparison of cilta-cel, an anti-BCMA CAR-T cell therapy, versus conventional treatment in patients with relapsed/refractory multiple myeloma. Clin Lymphoma Myeloma Leuk22(5), 326–335 (2022).
  • Mateos MV , WeiselK, MartinTet al. Adjusted comparison of outcomes between patients from CARTITUDE-1 versus multiple myeloma patients with prior exposure to PI, IMiD and anti-CD38 antibody from the prospective, multinational LocoMMotion study of real-world clinical practice. doi: https://doi.org/10.3324/haematol.2022.280482. (2022) ( Epub ahead of print).
  • Weisel K , MartinT, KrishnanAet al. Comparative efficacy of ciltacabtagene autoleucel in CARTITUDE-1 vs physician’s choice of therapy in the long-term follow-up of POLLUX, CASTOR, and EQUULEUS clinical trials for the treatment of patients with relapsed or refractory multiple myeloma. Clin Drug Investig42(1), 29–41 (2022).
  • Martin T , UsmaniSZ, SchecterJMet al. Matching-adjusted indirect comparison of efficacy outcomes for ciltacabtagene autoleucel in CARTITUDE-1 versus idecabtagene vicleucel in KarMMa for the treatment of patients with relapsed or refractory multiple myeloma. Curr. Med. Res. Opin.37(10), 1779–1788 (2021).
  • Weisel K , KrishnanA, SchecterJMet al. Matching-adjusted indirect treatment comparison to assess the comparative efficacy of ciltacabtagene autoleucel in CARTITUDE-1 versus belantamab mafodotin in DREAMM-2, selinexor-dexamethasone in STORM part 2, and melphalan flufenamide-dexamethasone in HORIZON for the treatment of patients with triple-class exposed relapsed or refractory multiple myeloma. Clin Lymphoma Myeloma Leuk22(9), 690–701 (2022).
  • Cohen AD , ParekhS, SantomassoBDet al. Incidence and management of CAR-T neurotoxicity in patients with multiple myeloma treated with ciltacabtagene autoleucel in CARTITUDE studies. Blood Cancer J12(2), 32 (2022).
  • Lee DW , SantomassoBD, LockeFLet al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant25(4), 625–638 (2019).
  • Neelapu SS , LockeFL, BartlettNLet al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N. Engl. J. Med.377(26), 2531–2544 (2017).
  • Schuster SJ , BishopMR, TamCSet al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N. Engl. J. Med.380(1), 45–56 (2019).
  • Wang M , MunozJ, GoyAet al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma. N. Engl. J. Med.382(14), 1331–1342 (2020).
  • Van Oekelen O , AlemanA, UpadhyayaBet al. Neurocognitive and hypokinetic movement disorder with features of parkinsonism after BCMA-targeting CAR-T cell therapy. Nat. Med.27(12), 2099–2103 (2021).
  • Marella M , YaoX, CarreiraVet al. Comprehensive BCMA expression profiling in adult normal human brain suggests a low risk of on-target neurotoxicity in BCMA-targeting multiple myeloma therapy. J. Histochem. Cytochem.70(4), 273–287 (2022).
  • Palumbo A , BringhenS, KumarSKet al. Second primary malignancies with lenalidomide therapy for newly diagnosed myeloma: a meta-analysis of individual patient data. Lancet Oncol15(3), 333–342 (2014).
  • Poh C , KeeganT, RosenbergAS. Second primary malignancies in multiple myeloma: a review. Blood Rev.46, 100757 (2021).
  • Usmani SZ , MartinT, BerdejaJet al. CARTITUDE-1 2-year update: cilta-cel efficacy and safety in patients with relapsed/refractory MM. Presented at: 84th Annual Meeting of the Japanese Society of Hematology, Fukuoka, Japan. (2022).
  • Engelhardt M , IhorstG, SinghMet al. Real-world evaluation of health-related quality of life in patients with multiple myeloma from Germany. Clin Lymphoma Myeloma Leuk21(2), e160–e175 (2021).
  • Martin T , LinY, AghaMet al. Health-related quality of life in the CARTITUDE-1 study of ciltacabtagene autoleucel for relapsed/refractory multiple myeloma. Lancet Haematol9(12), e897–e905 (2022).
  • Jordan K , ProskorovskyI, LewisPet al. Effect of general symptom level, specific adverse events, treatment patterns, and patient characteristics on health-related quality of life in patients with multiple myeloma: results of a European, multicenter cohort study. Support. Care Cancer22(2), 417–426 (2014).
  • Cohen AD , MateosMV, CohenYCet al. Efficacy and safety of cilta-cel in patients with progressive MM after exposure to other BCMA-targeting agents. Blood141(3), 219–230 (2023).
  • Jew S , BujarskiS, SoofCet al. Estimating a normal reference range for serum B-cell maturation antigen levels for multiple myeloma patients. Br. J. Haematol.192(6), 1064–1067 (2021).
  • Shah N , ChariA, ScottE, MezziK, UsmaniSZ. B-cell maturation antigen (BCMA) in multiple myeloma: rationale for targeting and current therapeutic approaches. Leukemia34(4), 985–1005 (2020).
  • Zudaire E , MadduriD, UsmaniSZet al. Translational analysis from CARTITUDE-1, an ongoing phase Ib/2 study of JNJ-4528 BCMA-targeted CAR-T cell therapy in relapsed and/or refractory multiple myeloma (R/R MM), indicates preferential expansion of CD8+ T cell central memory cell subset. Blood134, 928 (2019).
  • Zhao WH , LiuJ, WangBYet al. A phase I, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B cell maturation antigen, in patients with relapsed or refractory multiple myeloma. J Hematol Oncol11(1), 141 (2018).
  • Zudaire E . Correlates of cilta-cel response. In: 4th Immune Effector Cell Therapies in Multiple Myeloma Workshop.Boston, MA (2023).
  • Mi JQ , ZhaoWH, JingHet al. A phase 2, open-label study of ciltacabtagene autoleucel, and anti-BCMA CAR-T cell therapy, in chinese patients with relapsed/refractory multiple myeloma (CARTIFAN-1). J. Clin. Oncol.41(6), 1275–1284 (2023).
  • Einsele H , CohenAD, DelforgeMet al. Biological correlative analyses and updated clinical data of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, in lenalidomide (len)-refractory patients (pts) with progressive multiple myeloma (MM) after 1–3 prior lines of therapy (LOT): CARTITUDE-2, cohort A. J. Clin. Oncol.40, 8020 (2022).
  • van de Donk NWCJ , AghaM, CohenADet al. Biological correlative analyses and updated clinical data of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, in patients with multiple myeloma (MM) and early relapse after initial therapy: CARTITUDE-2, cohort B. J. Clin. Oncol.40, 8029 (2022).
  • Tozeau C , KrishnanA, MoreauPet al. Efficacy and safety of teclistamab (tec), a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients (pts) with relapsed/refractory multiple myeloma (RRMM) after exposure to other BCMA-targeted agents. J. Clin. Oncol.40, 8013 (2022).