even better,” said lead study author and presenter Sagar Lonial,
MD, professor and executive vice chair of the Department of
Hematology and Medical Oncology of Emory University School of
Medicine in Atlanta, Georgia.
The results were later published in The New England Journal of
Medicine.2
In the analysis, Dr. Lonial and colleagues randomized 646
patients with relapsed/refractory MM to either ELO+LEN+DEX
(n=321) or LEN+DEX (n=325). All patients were treated in 28-day
cycles until disease progression or unacceptable toxicity.
Patients had been treated with one to three prior therapies, with
a median of two prior therapies, which included bortezomib (70%),
thalidomide (48%), and lenalidomide (6%). Notably, 35 percent were
refractory to their last therapy, and 32 percent of patients had del17p.
At the data cut-off point, 35 percent of patients in the elotuzumab group and 21 percent of patients in the control group remained
on therapy. Discontinuation of treatment was largely attributable to
disease progression (42% in the ELO+LEN+DEX group and 47% in
the LEN+DEX group).
Patients were followed for a median of 24 months, with an
independent review committee monitoring and assessing treatment
response and disease progression.
Focusing on the primary endpoints of progression-free survival
(PFS) and overall response rate (ORR), treatment receiving the elotuzumab combination had a nearly five-month median increase in PFS
over the control group (HR=0.70; 95% CI 0.57-0.85; p=0.0004; TABLE).
On the safety side, grade 3 or 4 adverse events (≥15%) in the
ELO+LEN+DEX and LEN+DEX groups were neutropenia (25%
vs. 33%) and anemia (15% vs. 16%). Exposure-adjusted infection
TABLE. Rates of Primary Endpoints among ELOQUENT-2
Participants
Progression-free survival
(PFS), months
One-year PFS
Elotuzumab + lenalidomide + dexamethasone
(N=321)
Lenalidomide +
dexamethasone
(N=325)
19.4 (95% CI 16.6-22.2)
14.9 (95% CI 12.1-17.2)
68% (95% CI 63-73)
57% (95% CI 51-62)
Two-year PFS
41% (95% CI 35-47)
27% (95% CI 22-33)
Overall response rate
79% (95% CI 74-83)
66% (95% CI 60-71)
rates were the same in both arms, and infusion reactions occurred
in 10 percent of patients in the ELO group – most of which were
grade 1 or 2 reactions. A total of 210 deaths occurred: 94 in the
ELO+LEN+DEX group and 116 in the LEN+DEX group.
Importantly, Dr. Lonial noted, the PFS benefit was consistent
across two key subgroups with high-risk genetic features: del17p
and t[4;14]. These patients appeared to benefit from elotuzumab as
much as patients with average risk.
“It was particularly strik