1. ELOQUENT-2: Elotuzumab + Len/Dex in R/R MM
New Findings in Hematology: Independent Conference Coverage* of ASH 2015, December 5-8, 2015, Orlando, Florida
*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
This program is supported by educational grants from Amgen, Celgene, Incyte, Merck, Seattle Genetics, and Takeda Oncology.

2. ELOQUENT-2: Background
Elotuzumab: anti-SLAMF7 monoclonal antibody that acts via dual mechanism
Directly activates natural killer cells
Myeloma cell destruction by ADCC
In primary study analysis, elotuzumab + len/dex reduced risk of progression or death by 30% vs len/dex[1]
Elotuzumab approved November 30, 2015, for use with len/dex in pts with MM and 1-3 prior therapies[2]
Current analysis presents extended 3-yr safety and efficacy follow-up[3]
ADCC, antibody-dependent cell-mediated cytotoxicity; dex, dexamethasone; len, lenalidomide; MM, multiple myeloma.
1. Lonial S, et al. N Engl J Med. 2015;373: FDA.gov. Accessed December 5, Dimopoulos MA, et al. ASH Abstract 28.
Slide credit: clinicaloptions.com

3. ELOQUENT-2: Study Design
Randomized, open-label, multicenter phase III trial
Primary endpoints: PFS, ORR
Secondary endpoints: OS, safety, DoR, health-related QoL
Threshold for interim OS significance 0.014
Elotuzumab 10 mg/kg IV QW cycles 1, 2
then Q2W +
Lenalidomide 25 mg PO D1-21 +
Dexamethasone 40 mg PO QW
(n = 321)
Pts with R/R MM and 1-3 prior treatments
(N = 646)
Until PD or unacceptable toxicity
Lenalidomide 25 mg PO D1-21 +
Dexamethasone 40 mg PO QW
(n = 325)
DoR, duration of response; MM, multiple myeloma; QoL, quality of life; Q2W, once every 2 weeks; QW, once weekly; R/R, relapsed/refractory.
28-day cycles
Slide credit: clinicaloptions.com
Dimopoulos MA, et al. ASH Abstract 28.

4. ELOQUENT-2: Baseline Characteristics
Elotuzumab + Len/Dex
(n = 321)
Len/Dex
(n = 325)
ISS stage, % I II
III 44 32 21 42
Cytogenetics (FISH), %
del(17p)
t(4;14) 9 10
Prior treatments, median n (range)
2 (1-4)
Response to most recent therapy, %
Refractory
Relapsed 35 65
Dex, dexamethasone; ISS, International Scoring System; Len, lenalidomide.
Slide credit: clinicaloptions.com
Dimopoulos MA, et al. ASH Abstract 28.

5. ELOQUENT-2: Efficacy
Outcome
Elotuzumab + Len/Dex
(n = 321)
Len/Dex
(n = 325)
HR (95% CI)
PFS
Median, mos
1 yr, %
2 yrs, %
3 yrs, %
19.4 68 41 26
14.9 57 27 18
0.73 ( ;
P = .0014)
Median time to next treatment, mos 33 21
0.62 ( )
ORR, % 79 66
Interim OS, mos
43.7
39.6
0.77 ( ;
P = .0257)
Dex, dexamethasone; Len, lenalidomide.
PFS benefit seen with elotuzumab in all predefined subgroups
Slide credit: clinicaloptions.com
Dimopoulos MA, et al. ASH Abstract 28.

6. ELOQUENT-2: Safety
AE, %
Elotuzumab + Len/Dex
(n = 318)
Len/Dex
(n = 317)
Hematologic (grade ≥ 3)
Anemia
Neutropenia 15 26 16 33
Nonhematologic (grade ≥ 3)
Fatigue
Diarrhea
Pyrexia 9 5 3 8
GI disorders (any grade) 81 68
Respiratory disorders (any grade) 63 53
Renal/urinary (any grade) 25 18
Peripheral neuropathy (any grade)
Dex, dexamethasone; GI, gastrointestinal; Len, lenalidomide.
Infusion reactions experienced by 10% of pts; most were grade 1/2 and occurred during first treatment cycle
Slide credit: clinicaloptions.com
Dimopoulos MA, et al. ASH Abstract 28.

7. ELOQUENT-2: Conclusions
Elotuzumab in combination with len/dex improved PFS and ORR
At 3-yr follow-up, pts receiving elotuzumab had 27% reduction in risk of progression or death vs len/dex alone
Pts in elotuzumab arm had median delay of 1 yr in time to next treatment vs len/dex arm
Interim OS analysis shows trend in favor of elotuzumab arm
Elotuzumab plus len/dex toxicity profile consistent with prior studies with minimal increase in toxicities vs len/dex alone
Slide credit: clinicaloptions.com
Dimopoulos MA, et al. ASH Abstract 28.

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