Updated data from a phase II dose finding trial of single agent isatuximab (SAR650984, anti-CD38 mAb) in relapsed/refractory multiple myeloma (RRMM).

Richter, Joshua; Martin, Thomas; Vij, Ravi; Cole, Craig E.; Atanackovic, Djordje; Zonder, Jeffrey A.; Kaufman, Jonathan L.; Mıkhael, Joseph; Bensinger, William I.; Dimopoulos, Meletios A.; Zimmerman, Todd; Lendvai, Nikoletta; Hari, Parameswaran; Ocio, Enrique M.; Gasparetto, Cristina; Kumar, Shaji; Oprea, Corina; Charpentier, Eric; Strickland, Stephen A.; Miguel, Jesús San

doi:10.1200/jco.2016.34.15_suppl.8005

Cited by 31 publications

(30 citation statements)

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“…The most common ISA-related AEs were IARs, which occurred mostly during cycle 1; no IARs were observed after the fourth infusion. Overall, the safety profile of this combination was consistent with the safety profile of single-agent ISA and the combination of Len/dex alone [31,38]. Treatment of this heavily pretreated patient population (median five prior lines) with ISA plus Len/dex resulted in an ORR of 56%, including 17 (32.7%) VGPRs and two (3.8%) stringent complete responses (sCRs) [31].…”

supporting

confidence: 53%

“…Median time to first response was 4 weeks and median duration of response was approximately 25 weeks [38].…”

mentioning

confidence: 99%

“…The overall response rate (ORR) at doses ≥10 mg/kg ranged from 20 to 29% in a heavily pretreated patient population who had received a median of five prior lines of therapy [38]. Median time to first response was 4 weeks and median duration of response was approximately 25 weeks [38].…”

mentioning

confidence: 99%

“…These preclinical results supported the investigation of ISA as a monotherapy and in combination with IMiDs in clinical studies. The first-in-human, Phase I/II study of ISA as a single agent (NCT01084252) demonstrated clinical activity in a heavily pretreated RRMM population [37,38]. ISA was generally well tolerated in these patients.…”

mentioning

confidence: 99%

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Isatuximab Plus Pomalidomide/Dexamethasone Versus Pomalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma: Icaria Phase Iii Study Design

et al. 2017

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Treatment for relapsed/refractory multiple myeloma (RRMM) remains an unmet need. Isatuximab, an anti-CD38 monoclonal antibody has shown efficacy and tolerability as a monotherapy and combination therapy in Phase I/II studies in RRMM. Here, we describe the design of the Phase III ICARIA-MM study (NCT02990338) which will evaluate isatuximab in combination with pomalidomide (Pom) and low-dose dexamethasone (dex) (Pom/dex) versus Pom/dex alone in RRMM. Patients will be randomized in a 1:1 ratio. The primary endpoint is progression-free survival. Response will be determined by an independent response review committee using IMWG criteria (2016) and safety will be assessed throughout. Approximately 300 patients (150 in each arm) are expected to enroll. The first patient was recruited in January 2017 and accrual is ongoing.

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supporting

confidence: 53%

“…Median time to first response was 4 weeks and median duration of response was approximately 25 weeks [38].…”

mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Isatuximab Plus Pomalidomide/Dexamethasone Versus Pomalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma: Icaria Phase Iii Study Design

et al. 2017

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“…Plasma cell surface targets of mAbs that have already demonstrated significant clinical activity either alone or in combination with other approved myeloma drugs include signaling lymphocytic activation molecule F7 (SLAMF7) (elotuzumab [ELO]) and CD38 (daratumumab [DARA], isatuximab [ISA] [SAR659084], and MOR-202). [3][4][5][6][7] Other mAbs directed against MM cellular antigens that have demonstrated at least stable disease include those directed against CD138 (BT062), CD54/ICAM-1 (BI-505), and CD74 (milatuzumab). [8][9][10] The development of therapeutic mAbs for the treatment of MM has also been directed against growth factors and their receptors (eg, interleukin-6, interleukin-6 receptor, insulin-like growth factor-1 or -2, vascular endothelial growth factor, and B-cell activating factor).…”

Section: Targets For Monoclonal Antibody (Mab) Therapymentioning

confidence: 99%

Advances and practical use of monoclonal antibodies in multiple myeloma therapy

Lee

Weber

2016

Hematology

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The use of proteasome inhibitors and immunomodulatory agents in the treatment of myeloma have resulted in significant improvements in patient outcomes over the last decade. Although these agents now form the backbone of current myeloma treatment regimens both in the frontline and in a relapsed setting, drug resistance remains an inevitable challenge that most patients will encounter during their disease course. Hence, new treatment strategies continue to be explored, and the recent regulatory approvals of the monoclonal antibodies (mAbs) daratumumab (DARA) and elotuzumab (ELO), which target the plasma cell surface proteins CD38 and signaling lymphocytic activation molecule F7 (SLAMF7), respectively, have heralded the long-awaited era of antibody-based approaches in the treatment of myeloma. Hoping to build on these advances, a number of other mAbs are in various stages of clinical development, including those targeting myeloma cell surface antigens, the bone marrow microenvironment, and immune effector T cells such as anti-programmed cell death protein 1 antibodies. In this review, the current landscape and practical use of mAb-based therapy in myeloma will be discussed. Learning Objectives• Understand the current landscape of mAb-based therapy in myeloma, with a particular focus on the CD38-targeted therapy with DARA and SLAMF7-targeted therapy with ELO • Become aware of practical issues unique to mAb-based therapy in myeloma including red blood cell compatibility testing with anti-CD38-directed therapy and interference with myeloma laboratory response assessments

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Discovery, Development, and Mechanisms of Action of the HumanCD38Antibody Daratumumab

Janmaat

Donk

Bueren

et al. 2018

Successful Drug Discovery

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Updated data from a phase II dose finding trial of single agent isatuximab (SAR650984, anti-CD38 mAb) in relapsed/refractory multiple myeloma (RRMM).

Cited by 31 publications

References 0 publications

Isatuximab Plus Pomalidomide/Dexamethasone Versus Pomalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma: Icaria Phase Iii Study Design

Isatuximab Plus Pomalidomide/Dexamethasone Versus Pomalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma: Icaria Phase Iii Study Design

Advances and practical use of monoclonal antibodies in multiple myeloma therapy

Discovery, Development, and Mechanisms of Action of the HumanCD38Antibody Daratumumab

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