Elotuzumab

Source: Wikipedia, the free encyclopedia.
Elotuzumab
Humanized
TargetSLAMF7 (CD319)
Clinical data
Trade namesEmpliciti
Other namesHuLuc63
License data
Pregnancy
category
  • AU: C
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability100% (IV)
Identifiers
CAS Number
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6476H9982N1714O2016S42
Molar mass145453.59 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Elotuzumab, sold under the brand name Empliciti, is a humanized IgG1

acetaminophen.[4] It is being developed by Bristol Myers Squibb and AbbVie.[5]

Common

pregnant women.[3]

Elotuzumab is an immunostimulatory antibody that targets the Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7) through two mechanisms.[3]

In May 2014, it was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) (for multiple myeloma).[6] The initial FDA approval of elotuzumab in 2015 in combination with lenalidomide and dexamethasone was carried out through the results illustrated in the ELOQUENT 2 study.[7] In May 2016 the EC/EU gave a similar approval.[8] Furthermore, the results of the ELOQUENT 3 study led to the FDA approval of elotuzumab in combination with pomalidomide and dexamethasone in 2018.[9]

Medical use

Multiple myeloma

Elotuzumab is indicated for adult patients in combination treatment for multiple myeloma in patients that have received 1 to 3 prior therapies.[3] For medical use in multiple myeloma patients, elotuzumab can be combined with either lenalidomide and dexamethasone or pomalidomide and dexamethasone.[3]

Dosage and administration

In combination with lenalidomide and dexamethasone

The package insert advises that intravenous administration with 10 mg/kg every week for the first 2 cycles (each cycle is 28 days) and every 2 weeks thereafter, with the appropriate doses of lenalidomide and low dose dexamethasone is acceptable for treatment.[3] For additional information on dosing dexamethasone and/or lenalidomide, refer to the package inserts.[3]

In combination with pomalidomide and dexamethasone

Elotuzumab is recommended through intravenous administration at 10 mg/kg each week for the first 2 cycles (each cycle is 28 days).[3] At the start of cycle 3, administer 20 mg/kg every 4 weeks, while administering the recommended dose of pomalidomide and low dose dexamethasone.[3] For additional information on dosing dexamethasone and/or dexamethasone, refer to the package inserts.[3]

Adverse effects

To evaluate the adverse reactions in the Eloquent 2 trial, elotuzumab was combined with lenalidomide and dexamethasone and compared with lenalidomide and dexamethasone alone.[3][10][11] The most common adverse reactions (20% or higher) denoted in the elotuzumab treated patients in the study were:[3][10][11]

Similarly, the adverse reactions in the Eloquent 3 trial were examined by comparing the elotuzumab combined with pomalidomide and dexamethasone with the pomalidomide and dexamethasone alone.[3][12][13]

Mechanism of action

Elotuzumab is an immunostimulatory antibody that targets signaling lymphocyte activation molecule family member 7, also known as

hematopoietic lineage.[9]
 

Elotuzumab works by activating the natural killer cells through the SLAMF7 pathway.[3][9] Along with that, the SLAMF7 of the myeloma cells are targeted and flagged, for natural killer cell-mediated destruction through antibody-dependent cellular toxicity.[3][9]

Clinical trials

Eloquent 2 trial

The trial, Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma, also known as the Eloquent 2 trial, studied the

control group, the elotuzumab group had a significant relative reduction in the risk of disease progression or death.[10] The median progression-free survival for the elotuzumab group was 19.4 months compared with 14.9 months in the control group.[10] Additionally, the response rate for the etoluzumab group was 79%, compared to the control group with 66%.[10]

Eloquent 3 trial

In the Eloquent 3 trial, also known as Elotuzumab plus

control group, with 57 patients, received pomalidomide and dexamethasone alone.[12] Among patients that had failed treatment with lenalidomide and a protease inhibitor, death or risk of progression was significantly lower in the elotuzumab study arm.[12] The median progression-free survival in the elotuzumab study arm was 10.3 months compared to 4.7 months in the control study group, after a 9.1 month follow up period.[12]

References

  1. ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
  3. ^ a b c d e f g h i j k l m n o p q r s "Elotuzumab Package Insert" (PDF). Archived (PDF) from the original on 2015-12-08.
  4. ^ "Empliciti (elotuzumab) for Injection, for Intravenous Use. Full Prescribing Information" (PDF). Empliciti (elotuzumab) for US Healthcare Professionals. Princeton, New Jersey: Bristol-Myers Squibb Company. Archived from the original (PDF) on 2015-12-08.
  5. ^ "Bristol Myers Squibb Reports Primary Results of ELOQUENT-1 Study Evaluating Empliciti (elotuzumab) Plus Revlimid (lenalidomide) and Dexamethasone in Patients with Newly Diagnosed, Untreated Multiple Myeloma". news.bms.com. Retrieved 2021-03-18.
  6. ^ "Bristol-Myers Squibb and AbbVie Receive U.S. FDA Breakthrough Therapy Designation for Elotuzumab, an Investigational Humanized Monoclonal Antibody for Multiple Myeloma" (Press release). Princeton, New Jersey and North Chicago, Illinois: Bristol-Myers Squibb. 2014-05-19. Retrieved 2015-02-05.
  7. ^ "Bristol-Myers Squibb and AbbVie Receive FDA Approval of Empliciti™ (elotuzumab) for the Treatment of Patients with Multiple Myeloma Who Have Received One to Three Prior Therapies". news.bms.com. Retrieved 2021-03-18.
  8. ^ BMS gets two new cancer approvals in Europe. May 2016
  9. ^ a b c d e "U.S. Food and Drug Administration Approves Empliciti® (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma". news.bms.com. Retrieved 2021-03-18.
  10. ^
    PMID 26035255
    .
  11. ^ a b c Clinical trial number NCT01239797 for "Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma (ELOQUENT - 2)" at ClinicalTrials.gov
  12. ^
    PMID 30403938
    .
  13. ^ "Eloquent 3 Trial". 6 July 2020. Archived from the original on 2017-01-20.
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