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EMPLICITI™(elotuzumab) for injection

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

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

Visit the EMPLICITI Patient Site

Indication

EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

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Efficacy results

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 benefit1,6

chart shows progression-free survival with a minimum of 48 months, HR 0.70, 95% CI, 0.57, 0.85, P=0.0004 (co-primary endpoint). chart shows progression-free survival with a minimum of 48 months, HR 0.70, 95% CI, 0.57, 0.85, P=0.0004 (co-primary endpoint).

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

Exploratory endpoints at primary analysis of PFS:
1-year: 68% ERd, 57% Rd;
2-year: 41% ERd, 27% Rd1

Early separation between treatment arms was observed at 2 months and was maintained throughout the duration of the trial1,2,6

Minimum follow-up for PFS6 60 MONTHS

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

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

EMPLICITI + Rd relative to Rd alone
Consistent PFS results across subgroups through 2 years2,7

image shows patient sub-groups of interest, ERD (n=321) and Rd (n=325)> image shows patient sub-groups of interest, ERD (n=321) and Rd (n=325)>

Based on a pre-specified exploratory analysis
ISS=International Staging System.
IMiD=Immunomodulatory drug.

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.

The results of the EMPLICITI Phase 3 study were achieved by treating patients to progression or unacceptable toxicity1,2


A Phase 3, randomized, open-label study evaluated the efficacy and safety of EMPLICITI in combination with Rd1

image shows a phase 3 randomized open label study design of EMPLICITI and patient groups. Patients with relapased or refractory multiple myeloma and 1-3 prior therapies (N=644) in a 1:1 randomization with one group getting ERd (n=321) EMPLICITI 10 mg/kg + lenalidomide 25 mg + dexamethasone. The second group got Rd (n=325) Lenalidomide 25 mg + dexamethasone. Both groups had continuous treatment until disease progression or unacceptable toxicity. image shows a phase 3 randomized open label study design of EMPLICITI and patient groups. Patients with relapased or refractory multiple myeloma and 1-3 prior therapies (N=644) in a 1:1 randomization with one group getting ERd (n=321) EMPLICITI 10 mg/kg + lenalidomide 25 mg + dexamethasone. The second group got Rd (n=325) Lenalidomide 25 mg + dexamethasone. Both groups had continuous treatment until disease progression or unacceptable toxicity.

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

IMPORTANT SAFETY INFORMATION ABOUT INFECTIONS AND SECOND PRIMARY MALIGNANCIES

Infections
  • In a clinical trial of patients with multiple myeloma (N=635), infections were reported in 81.4% of patients in the EMPLICITI with lenalidomide/dexamethasone arm (ERd) and 74.4% in the lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28% (ERd) and 24.3% (Rd). Opportunistic infections were reported in 22% (ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and 5.4% (Rd). Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Monitor patients for development of infections and treat promptly.
Second Primary Malignancies
  • In a clinical trial of patients with multiple myeloma (N=635), invasive second primary malignancies (SPM) were 9.1% (ERd) and 5.7% (Rd). The rate of hematologic malignancies were 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.

Please see additional Important Safety Information below.

 

Demographics and baseline disease characteristics were balanced between treatment arms2,4


Table showing demographics and baseline disease characteristics.

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.4
†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.4

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

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More Important Safety Information

Important Safety
Information

Important Safety
Information

Infusion Reactions

  • EMPLICITI can cause infusion reactions. Common symptoms include 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 infusing with EMPLICITI.

Infections

  • In a clinical trial of patients with multiple myeloma (N=635), infections were reported in 81.4% of patients in the EMPLICITI with lenalidomide/dexamethasone arm (ERd) and 74.4% in the lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28% (ERd) and 24.3% (Rd). Opportunistic infections were reported in 22% (ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and 5.4% (Rd). Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Monitor patients for development of infections and treat promptly.

Second Primary Malignancies

  • In a clinical trial of patients with multiple myeloma (N=635), invasive second primary malignancies (SPM) were 9.1% (ERd) and
    5.7% (Rd). The rate of hematologic malignancies were 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

  • Elevations in liver enzymes (AST/ALT greater than 3 times the upper limit, total bilirubin greater than 2 times the upper limit, and alkaline phosphatase less than 2 times the upper limit) consistent with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients experiencing hepatotoxicity discontinued treatment; however, 6 out of 8 patients had resolution and continued treatment. Monitor liver enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation of liver enzymes. After return to baseline values, continuation of treatment may be considered.

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 studies with EMPLICITI with pregnant women to inform any drug associated risks.
  • There is a risk of fetal harm, including severe life-threatening human birth defects associated with lenalidomide and it is contraindicated for use in pregnancy. Refer to the lenalidomide 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

  • Infusion reactions were reported in approximately 10% of patients treated with EMPLICITI with lenalidomide and dexamethasone. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients.
  • Serious adverse reactions were 65.4% (ERd) and 56.5% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15.4%, 11%), pyrexia (6.9%, 4.7%), 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 (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%), and pneumonia (20.1%, 14.2%).

Please see the Full Prescribing Information.

References

  1. EMPLICITI [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. 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.
  3. Cheng M, Chen Y, Xiao W, Sun R, Tian Z. NK cell-based immunotherapy for malignant diseases. Cell Mol Immunol. 2013;10(3):230-252.
  4. 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.
  5. BMS-REF-ELOT 047 [Data on file]. Bristol-Myers Squibb. 2016.
  6. 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.
  7. BMS-REF-ELOT 039 [Data on file]. Bristol-Myers Squibb. 2016.
  8. BMS-REF-ELOT 048 [Data on file]. Bristol-Myers Squibb. 2016.
  9. BMS-REF-ELOT 008 [Data on file]. Bristol-Myers Squibb. 2015.
 

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