TY - JOUR
T1 - Recent Developments in Convenience of Administration of the Anti-CD38 Antibody Isatuximab
T2 - Subcutaneous Delivery and Fast Intravenous Infusion in Patients With Multiple Myeloma
AU - Quach, Hang
AU - Parmar, Gurdeep
AU - Mateos, Maria Victoria
AU - Ailawadhi, Sikander
AU - Leleu, Xavier
N1 - Publisher Copyright:
© 2024 Elsevier Inc.
PY - 2024
Y1 - 2024
N2 - Isatuximab-based combinations are among the accepted standard-of-care regimens for early-line treatment of patients with relapsed/refractory multiple myeloma (RRMM), based on the results of the Phase 3 ICARIA-MM and IKEMA trials. Further study findings have shown benefit with Isa-based combinations in patients with newly diagnosed MM, as reported from the randomized GMMG-HD7 and CONCEPT trials. Isa is currently approved in various countries for intravenous (IV) administration in patients with RRMM. A more convenient route of administration, such as subcutaneous (SC) injection, and faster IV infusion may substantially increase convenience of treatment. In this review, we outline evidence emerging from clinical trials that shows increasing clinical applicability of Isa across the MM therapeutic spectrum. We then review recent study results demonstrating that new treatment modalities, either SC Isa administration via an on-body delivery system (OBDS) or fast, 30-minute, fixed-volume IV infusion, are safe and effective, and enhance convenience of treatment with Isa for MM patients and healthcare providers. In the recently reported Phase 1b study, the safety profile and efficacy of Isa administered SC plus pomalidomide-dexamethasone were comparable to those observed with Isa administered IV plus pomalidomide-dexamethasone in the control arm and in the ICARIA-MM trial. Analysis of patient-reported outcomes indicated patient confidence in SC Isa administration and satisfaction with treatment delivery by OBDS. These findings point to SC administration as the preferred route for future treatment with Isa-based combinations, as well as to the use of fast, 30-minute IV infusions in settings where SC administration of Isa might not be available.
AB - Isatuximab-based combinations are among the accepted standard-of-care regimens for early-line treatment of patients with relapsed/refractory multiple myeloma (RRMM), based on the results of the Phase 3 ICARIA-MM and IKEMA trials. Further study findings have shown benefit with Isa-based combinations in patients with newly diagnosed MM, as reported from the randomized GMMG-HD7 and CONCEPT trials. Isa is currently approved in various countries for intravenous (IV) administration in patients with RRMM. A more convenient route of administration, such as subcutaneous (SC) injection, and faster IV infusion may substantially increase convenience of treatment. In this review, we outline evidence emerging from clinical trials that shows increasing clinical applicability of Isa across the MM therapeutic spectrum. We then review recent study results demonstrating that new treatment modalities, either SC Isa administration via an on-body delivery system (OBDS) or fast, 30-minute, fixed-volume IV infusion, are safe and effective, and enhance convenience of treatment with Isa for MM patients and healthcare providers. In the recently reported Phase 1b study, the safety profile and efficacy of Isa administered SC plus pomalidomide-dexamethasone were comparable to those observed with Isa administered IV plus pomalidomide-dexamethasone in the control arm and in the ICARIA-MM trial. Analysis of patient-reported outcomes indicated patient confidence in SC Isa administration and satisfaction with treatment delivery by OBDS. These findings point to SC administration as the preferred route for future treatment with Isa-based combinations, as well as to the use of fast, 30-minute IV infusions in settings where SC administration of Isa might not be available.
KW - Infusion pump
KW - Newly diagnosed multiple myeloma
KW - OBDS
KW - on-body delivery system, Relapsed/refractory multiple myeloma
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U2 - 10.1016/j.clml.2024.02.004
DO - 10.1016/j.clml.2024.02.004
M3 - Review article
AN - SCOPUS:85188706144
SN - 2152-2650
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
ER -