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
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
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
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
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
- 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
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.