EMPLICITI®(elotuzumab) for injection

Call 1-844-EMPLICITI (1-844-367-5424)

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Visit the EMPLICITI Patient Site

Call 1-844-EMPLICITI (1-844-367-5424)

This site is intended for
U.S. Healthcare Professionals only.

INDICATIONS

EMPLICITI® (elotuzumab) is indicated for the treatment of adult patients with multiple myeloma in combination with:

  • lenalidomide and dexamethasone after one to three prior therapies
  • pomalidomide and dexamethasone after at least two prior therapies including lenalidomide and a proteasome inhibitor
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EMPLICITI + Rd Efficacy

In combination with Rd relative to Rd alone, in patients who received 1 to 3 prior therapies,

EMPLICITI is the ONLY therapy that demonstrated a 5-YEAR PFS benefit1,3

PROGRESSION-FREE SURVIVAL

EMPLICITI is the ONLY therapy that demonstrated a 5-year PFS benefit

mPFS: ERd 19.4 months [95% CI, 16.6, 22.2] vs Rd 14.9 months [95% CI, 12.1, 17.2]1

Early separation between treatment arms was observed at 2 months and was maintained throughout the duration of the trial.1,3,4

Primary analysis of PFS conducted with a minimum follow-up of 24 months1

Minimum follow-up for PFS3

60

MONTHS

Exploratory endpoints1:

1-year: 68% ERd, 57% Rd

2-year: 41% ERd, 27% Rd

Co-primary endpoint1:

ORR*: ERd 78.5% [95% CI, 73.6, 82.9]

Rd 65.5% [95% CI, 60.1, 70.7]

P=0.0002

*

Assessed by blinded Independent Review Committee per European Group for Blood and Marrow Transplantation (EBMT) response criteria. ORR includes complete response, very good partial response, and partial response.1

ELOQUENT-2 trial was a Phase 3, randomized, open-label study that evaluated the efficacy and safety of EMPLICITI in combination with Rd vs Rd alone. See study design

SELECTED IMPORTANT SAFETY INFORMATION

Infusion Reactions

  • Infusion reactions were reported in 10% of patients treated with EMPLICITI in the ELOQUENT-2 trial [EMPLICITI + lenalidomide + dexamethasone (ERd) vs lenalidomide + dexamethasone (Rd)]. All infusion reactions were Grade 3 or lower, with Grade 3 infusion reactions occurring in 1% of patients. The most common symptoms included fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose.
  • If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.
  • Premedicate with dexamethasone, H1 blocker, H2 blocker, and acetaminophen prior to EMPLICITI infusion.

Please see additional Important Safety Information below.

CI, confidence interval; ERd, EMPLICITI + lenalidomide + dexamethasone; HR, hazard ratio; mPFS, median progression-free survival; ORR, overall response rate; PFS, progression-free survival; Rd, lenalidomide + dexamethasone.

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EPd Efficacy

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EPd Safety

Overall survival: 36-month interim analysis1

INTERIM OVERALL SURVIVAL1

Interim 3-year overall survival

Interim analysis, conducted with a minimum follow-up of 35.4 months and after 295 events occurred, did not meet the required P-value threshold for statistical significance6

Final analysis of OS will be conducted after at least 427 deaths have been observed6

ELOQUENT-2 trial was a Phase 3, randomized, open-label study that evaluated the efficacy and safety of EMPLICITI in combination with Rd vs Rd alone.
See study design

SELECTED IMPORTANT SAFETY INFORMATION

Infections

  • In the ELOQUENT-2 trial (N=635), infections were reported in 81% of patients in the ERd arm and 74% in the Rd arm. Grade 3-4 infections were 28% (ERd) and 24% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Opportunistic infections were reported in 22% (ERd) and 13% (Rd). Fungal infections were 10% (ERd) and 5% (Rd). Herpes zoster was 14% (ERd) and 7% (Rd).
  • Monitor patients for development of infections and treat promptly.

Please see additional Important Safety Information below.

OS, overall survival.

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EPd Efficacy

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The results of the EMPLICITI Phase 3 study were achieved by treating patients to progression or unacceptable toxicity1,4

A Phase 3, randomized, open-label study evaluated the efficacy and safety of EMPLICITI in combination with Rd vs Rd alone1

ERd TRIAL DESIGN

The results of the EMPLICITI Phase 3 study

Co-primary endpoints:
Progression-free survival; overall response rate1

Minimum follow-up for PFS: 24 months1

*

Prior to EMPLICITI infusion, dexamethasone was administered as a divided dose; an oral dose of 28 mg and an intravenous dose of 8 mg. In the control group and on weeks without EMPLICITI, dexamethasone 40 mg was administered as a single oral dose. Each cycle was 28 days.1

SELECTED IMPORTANT SAFETY INFORMATION

Second Primary Malignancies

  • In the ELOQUENT-2 trial (N=635), invasive second primary malignancies (SPM) were 9% (ERd) and 6% (Rd). The rate of hematologic malignancies was the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd). Monitor patients for the development of SPMs.

Hepatotoxicity

  • In the ELOQUENT-2 trial (N=635), AST/ALT >3X the upper limit, total bilirubin >2X the upper limit, and alkaline phosphatase <2X the upper limit were 2.5% (ERd) vs 0.6% (Rd). Of 8 patients experiencing hepatotoxicity, 2 patients discontinued treatment while 6 patients had resolution and continued. Monitor liver enzymes periodically. Stop EMPLICITI upon ≥Grade 3 elevation of liver enzymes. Continuation of treatment may be considered after return to baseline values.

Please see additional Important Safety Information below.

Demographics and baseline disease characteristics were balanced between treatment arms4,7

DEMOGRAPHICS AND BASELINE DISEASE CHARACTERISTICS4,7

Demographics and baseline disease characteristics were balanced between treatment arms

Selected ERd demographics

  • 58% ≥65 years of age
  • 32% del(17p) positive
  • 9% t(4;14) positive
  • 35% refractory to most recent line of therapy

*

One patient in the EMPLICITI group had an unknown response to the most recent line of therapy.7

Prior lenalidomide was permitted if patient had: partial response or better; no disease progression within 9 months of last dose; 9 or fewer cycles of lenalidomide; and did not discontinue lenalidomide due to grade 3 or higher adverse events.7

ERd, EMPLICITI + lenalidomide + dexamethasone; ISS, International Staging System; Rd, lenalidomide + dexamethasone.

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More Important Safety Information

Important Safety
Information More Important Safety InformationCollapse

Important Safety
Information

Infusion Reactions

  • Infusion reactions were reported in 10% of patients treated with EMPLICITI in the ELOQUENT-2 trial [EMPLICITI + lenalidomide + dexamethasone (ERd) vs lenalidomide + dexamethasone (Rd)] and 3.3% in the ELOQUENT-3 trial [EMPLICITI + pomalidomide + dexamethasone (EPd) vs pomalidomide + dexamethasone (Pd)].
  • In the ELOQUENT-2 trial, all infusion reactions were Grade 3 or lower, with Grade 3 infusion reactions occurring in 1% of patients. The most common symptoms included fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose.
  • In the ELOQUENT-3 trial, the only infusion reaction symptom was chest discomfort (2%), which was Grade 1. All the patients who experienced an infusion reaction had them during the first treatment cycle.
  • If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.
  • Premedicate with dexamethasone, H1 blocker, H2 blocker, and acetaminophen prior to EMPLICITI infusion.

Infections

  • In the ELOQUENT-2 trial (N=635), infections were reported in 81% of patients in the ERd arm and 74% in the Rd arm. Grade 3-4 infections were 28% (ERd) and 24% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Opportunistic infections were reported in 22% (ERd) and 13% (Rd). Fungal infections were 10% (ERd) and 5% (Rd). Herpes zoster was 14% (ERd) and 7% (Rd).
  • In the ELOQUENT-3 trial (N=115), infections were reported in 65% of patients in both the EPd arm and the Pd arm. Grade 3-4 infections were reported in 13% (EPd) and 22% (Pd). Discontinuations due to infections were 7% (EPd) and 5% (Pd). Fatal infections were 5% (EPd) and 3.6% (Pd). Opportunistic infections were reported in 10% (EPd) and 9% (Pd). Herpes zoster was reported in 5% (EPd) and 1.8% (Pd).
  • Monitor patients for development of infections and treat promptly.

Second Primary Malignancies

  • In the ELOQUENT-2 trial (N=635), invasive second primary malignancies (SPM) were 9% (ERd) and 6% (Rd). The rate of hematologic malignancies was the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd).
  • In the ELOQUENT-3 trial (N=115), invasive SPMs were 0% (EPd) and 1.8% (Pd).
  • Monitor patients for the development of SPMs.

Hepatotoxicity

  • In the ELOQUENT-2 trial (N=635), AST/ALT >3X the upper limit, total bilirubin >2X the upper limit, and alkaline phosphatase <2X the upper limit were 2.5% (ERd) vs 0.6% (Rd). Of 8 patients experiencing hepatotoxicity, 2 patients discontinued treatment while 6 patients had resolution and continued. Monitor liver enzymes periodically. Stop EMPLICITI upon ≥Grade 3 elevation of liver enzymes. Continuation of treatment may be considered after return to baseline values.

Interference with Determination of Complete Response

  • EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.

Pregnancy/Females and Males of Reproductive Potential

  • There are no available data on EMPLICITI use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.
  • There is a risk of fetal harm, including severe life-threatening human birth defects, associated with lenalidomide and pomalidomide, and they are contraindicated for use in pregnancy. Refer to the respective product full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.

Adverse Reactions

  • ELOQUENT-2 trial:
    • Serious adverse reactions were 65% (ERd) and 57% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15%, 11%), pyrexia (7%, 5%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
    • The most common adverse reactions in ERd and Rd, respectively (≥20%) were fatigue (62%, 52%), diarrhea (47%, 36%), pyrexia (37%, 25%), constipation (36%, 27%), cough (34%, 19%), peripheral neuropathy (27%, 21%), nasopharyngitis (25%, 19%), upper respiratory tract infection (23%, 17%), decreased appetite (21%, 13%), and pneumonia (20%, 14%).
  • ELOQUENT-3 trial:
    • Serious adverse reactions were 22% (EPd) and 15% (Pd). The most frequent serious adverse reactions in the EPd arm compared to the Pd arm were: pneumonia (13%, 11%) and respiratory tract infection (7%, 3.6%).
    • The most common adverse reactions in EPd arm (≥20% EPd) and Pd, respectively, were constipation (22%, 11%) and hyperglycemia (20%, 15%).

Please see the Full Prescribing Information.

References

  1. EMPLICITI [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma. N Engl J Med. 2018;379(19):1811-1822.
  3. Lonial S, Dimopoulos M, Weisel K, et al. Extended 5-y follow-up (FU) of phase 3 ELOQUENT-2 study of elotuzumab + lenalidomide/dexamethasone (ELd) vs Ld in relapsed/refractory multiple myeloma (RRMM). Poster presentation at: 2018 American Society of Clinical Oncology (ASCO) Annual Meeting; June 1-5, 2018; Chicago, IL. Poster #8040.
  4. Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373(7):621-631.
  5. BMS-REF-ELOT 039 [Data on file]. Bristol-Myers Squibb. 2016.
  6. BMS-REF-ELOT 048 [Data on file]. Bristol-Myers Squibb. 2016.
  7. Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373(suppl):1-18.
  8. BMS-REF-ELOT 047 [Data on file]. Bristol-Myers Squibb. 2016.
  9. Kurdi AT, Glavey SV, Bezman NA, et al. Antibody-dependent cellular phagocytosis by macrophages is a novel mechanism of action of elotuzumab. Mol Cancer Ther. 2018;17(7):1454-1463.
 

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