Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma

Munshi, Nikhil C.; Anderson, Larry D.; Shah, Nina; Madduri, Deepu; Berdeja, Jesús G.; Lonial, Sagar; Raje, Noopur; Lin, Yi; Siegel, David S.; Oriol, Albert; Moreau, Philippe; Yakoub‐Agha, Ibrahim; Delforge, Michel; Cavo, Michèle; Einsele, Hermann; Goldschmidt, Hartmut; Weisel, Katja; Rambaldi, Alessandro; Reece, Donna; Petrocca, Fabio; Massaro, Mónica; Connarn, Jamie; Kaiser, Shari M.; Patel, Payal; Huang, Liping; Campbell, Timothy B.; Hege, Kristen; Miguel, Jesús F. San

doi:10.1056/nejmoa2024850

Cited by 1,570 publications

(1,517 citation statements)

References 16 publications

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“…Studies from the last three years (Table 3), report that incidence of hemocytopenia is high in CAR-T cell therapy. Furthermore, studies have reported that cytopenia is the most prevalent among all adverse reactions reported with ≥ grade 3 (13,14).…”

Section: Cytopeniasmentioning

confidence: 99%

Reactions Related to CAR-T Cell Therapy

et al. 2021

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The application of chimeric antigen receptor (CAR) T-cell therapy as a tumor immunotherapy has received great interest in recent years. This therapeutic approach has been used to treat hematological malignancies solid tumors. However, it is associated with adverse reactions such as, cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), off-target effects, anaphylaxis, infections associated with CAR-T-cell infusion (CTI), tumor lysis syndrome (TLS), B-cell dysplasia, hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) and coagulation disorders. These adverse reactions can be life-threatening, and thus they should be identified early and treated effectively. In this paper, we review the adverse reactions associated with CAR-T cells, the mechanisms driving such adverse reactions, and strategies to subvert them. This review will provide important reference data to guide clinical application of CAR-T cell therapy.

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Section: Cytopeniasmentioning

confidence: 99%

Reactions Related to CAR-T Cell Therapy

et al. 2021

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“…In contrast with CAR T cells and bispecific antibodies, Belamaf could be prescribed in the elderly. In fact, among patients enrolled in the DREAMM-2 trial, 58 59% were 65 years or older, whereas, in the KarMMa trial, 35 using idecabtagene vicleucel, a CAR T cell therapy, 35% of patients were ≥ 65 years old. As shown above, grade 3–4 neutropenia, thrombocytopenia, and infections occurred in 22%, 11%, and 7%, respectively, of patients receiving Belamaf 2.5 mg/kg vs 89%, 52%, and 22% seen in patients treated with CAR T cell therapy.…”

Section: Discussionmentioning

confidence: 99%

Belantamab Mafodotin for the Treatment of Multiple Myeloma: An Overview of the Clinical Efficacy and Safety

Offidani¹,

Corvatta²,

Morè³

et al. 2021

DDDT

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Despite the introduction of immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs), and, more recently, monoclonal antibodies (mAbs), in the chemotherapy regimens for newly diagnosed (NDMM) and relapsed/refractory MM (RRMM), the occurrence of drug resistance remains a challenge in MM patients. This is mainly in the advanced stage of the disease when treatments are limited, and the prognosis is abysmal. Nevertheless, novel molecules and therapeutic approaches are rapidly moving through the several phases of drug development and could address the need for new treatment options. The recent innovative B-cell maturation antigen (BCMA) targeted immunotherapies, such as belantamab mafodotin, the first-in-class monoclonal antibody-drug conjugate (ADC), induce an effective and durable response in triple-class refractory disease and to be approved in MM. In contrast with the other BCMA-targeted therapies as CAR T cells with a complex manufacturing process, and bispecific antibodies, both requiring inpatient hospitalization to monitor the occurrence of severe adverse events, belantamab mafodotin is an “off-the-shelf” drug that can be administered in an outpatient setting. Many belantamab mafodotin-based combinations are under evaluation in Phase I, II, and III clinical trials either late or in early RRMM patients. Ocular toxicity represents a peculiar side effect of belantamab mafodotin. This toxicity is generally manageable with adequate dose reductions or delays since most patients who developed keratopathy recovered on treatment and discontinued ADC are rare. Here, we described the most recent clinical data of belantamab mafodotin and discussed the possible leading role of this intriguing agent in the near future of MM treatment.

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“…Still, the reduced quality-of-life in the period after transplant, as well as the increased mutational burden and increase in secondary malignancies seen after alkylator use, remains a concern. Efficacious immunotherapy, including chimeric-antibody-receptor T cells (CAR-Ts) and bispecific antibodies, have provided better results in terms of response rates and progression-free survival in later lines, and the possibility of including these agents as part of first-line treatments may again challenge HDM in first line [ 136 , 137 ]. Currently, several trials are being performed in which these agents are incorporated in first-line treatment in a design without HDM (e.g., NCT04196491, ).…”

Section: Future Use Of Alkylatorsmentioning

confidence: 99%

Current and Novel Alkylators in Multiple Myeloma

Schjesvold

Oriol

2021

Cancers

Self Cite

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A large number of novel treatments for myeloma have been developed and approved; however, alkylating drugs continue to be part of standard regimens. Additionally, novel alkylators are currently being developed. We performed a non-systematized literary search for relevant papers and communications at large conferences, as well as exploiting the authors’ knowledge of the field, to review the history, current use and novel concepts around the traditional alkylators cyclophosphamide, bendamustine and melphalan and current data on the newly developed pro-drug melflufen. Even in the era of targeted treatment and personalized medicine, alkylating drugs continue to be part of the standard-of-care in myeloma, and new alkylators are coming to the market.

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Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma

Cited by 1,570 publications

References 16 publications

Reactions Related to CAR-T Cell Therapy

Reactions Related to CAR-T Cell Therapy

Belantamab Mafodotin for the Treatment of Multiple Myeloma: An Overview of the Clinical Efficacy and Safety

Current and Novel Alkylators in Multiple Myeloma

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