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CLINICAL NEWS
Combining Ibrutinib and Venetoclax Produces
High MRD-Negative Rates in Treatment-Naïve CLL
Attendees at the 23rd EHA Congress.
investigators found no association between
AMV564 therapy and these events. There
also were no observations of CRS in the
≤15 mcg/day dose levels, but one patient
experienced manageable grade 2 CRS in
the 50 mcg/day dose cohort.
In 10 of the 16 patients who were con-
sidered evaluable at the data cutoff point, in-
vestigators observed reductions in BM blasts
ranging from 13 to 38 percent. Among
patients whose disease progressed following
cycle one (n=3), two showed reductions in
BM blasts following the second cycle.
One patient with a history of myelo-
dysplastic syndromes experienced a rapid
hemoglobin increase of >4 g/dL. This
patient also achieved transfusion inde-
pendence and experienced an increase in
absolute neutrophil count to >2,400/mm 3 ,
suggesting evidence of AMV564 clearing
myeloid-derived suppressor cells from the
peripheral blood; however, these data are
preliminary, Dr. Westervelt noted.
“Overall, the drug was well tolerated
as a 14-day continuous infusion, with no
dose-limiting toxicity or off-target effects,
and [there was] no mortality at 30 days,”
he added. “Modest evidence of activity was
observed, manifested by inflammatory cyto-
kine profiles, T-cell activation markers, and
reductions in BM blast counts, demonstra-
ting ‘proof of biology’ even at the relatively
low doses studied to date.”
“T-cell mediated immunotherapies,
such as T-cell engagers, have the potential
for broad activity to overcome resistance
to chemotherapy,” Dr. Westervelt con-
cluded. “If the ongoing study confirms
a wide therapeutic window and lack of
non-hematologic toxicity, AMV564 may
be an ideal partner for use with other
anti-leukemic agents, including standard
chemotherapy or targeted agents such as
inhibitors of FLT3 and IDH1/2.”
Dr. Westervelt reports a financial
relationship with Amphivena, the manufac-
turer of AMV564 and sponsor of the trial.
REFERENCE
Westervelt P, Roboz GJ, Cortes JE, et al. Phase 1 first-in-human trial
of AMV564, a bivalent bispecific (2×2) CD33/CD3 T-cell engager, in
patients with relapsed/refractory acute myeloid leukemia (AML).
Abstract #S859. Presented at the 23rd Congress of the European
Hematology Association, June 16, 2018; Stockholm, Sweden.
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