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
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 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 Safety
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
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
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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EPd Efficacy
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EPd Safety
EMPLICITI + Rd relative to Rd alone
Consistent PFS results across subgroups through 2 years4,5
Based on a prespecified exploratory analysis.
ISS, International Staging System.
IMiD, Immunomodulatory drug.