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NEWS
BCMA Bispecific Antibody “Promising” for Relapsed or Refractory Myeloma
Interim results from a phase I dose-finding study
suggest that CC-93269, a bispecific antibody that
binds B-cell maturation antigen (BCMA) on malignant
plasma cells and CD3 on T cells, is active
in patients with relapsed or refractory multiple
myeloma. However, treatment-related adverse
events (AEs) were common, with more than
three-quarters of patients experiencing
cytokine release syndrome
(CRS).
These findings were presented
at EHA25 Virtual, the remotely held
25th European Hematology Association
Annual Congress, by Luciano
J. Costa, MD, of University of Alabama
at Birmingham.
The study enrolled 30 adults
who had received at least 3 prior
therapies for myeloma, but no prior
BCMA-directed therapy, and whose
disease had progressed within 60
days of last treatment.
CC-93269 was administered intravenously
at doses ranging from 0.15
to 10 mg over 2 hours on days 1, 8, 15,
and 22 for cycles 1 to 3; days 1 and 15
for cycles 4 to 6; and day 1 for cycle
7 and beyond. Patients received fixed
doses during stage 1 of the study; in
stage 2, patients received a first fixed
dose of CC-93269, followed by intrapatient
escalating doses starting on
day 8 of cycle 1. Per study protocol,
treatment could be given for up to 2
years.
Dr. Costa described the patient
population as heavily pretreated, with
a median of 5 prior therapies (range
= 3-13). The median age of patients
was 64 years (range = 42-78). Approximately
one-third of patients (n=9)
had high-risk cytogenetics.
Patients received a median of 3.5
treatment cycles. All but 1 patient
experienced a treatment-related AE,
and nearly three-quarters (n=22;
73%) experienced a grade 3/4 AE.
The most common grade ≥3 hematologic
AEs included:
• neutropenia (43%)
• anemia (37%)
after the first dose and in patients receiving
CC-93269 at 6 mg or higher, Dr. Costa noted.
Four patient deaths were reported. One
patient receiving CC-93269 6 mg as first dose
and 10 mg on day 8 of cycle 1 developed CRS
and died; contributing factors were rapid myeloma
progression with extensive extramedullary
IN RELAPSED/REFRACTORY DISEASE,
DISMANTLE THE PARADIGM IN
Mantle cell lymphoma (MCL)
is an aggressive B-cell
malignancy that is
considered incurable 1
disease and concomitant infection. The other 3
deaths were considered unrelated to CC-93269
treatment.
In the preliminary efficacy analysis, the
researchers reported an overall response rate
of 43%, with 13 patients achieving a partial
response or better, including 5 (17%) who
The quality and duration
of remission decrease
with each subsequent
line of therapy 2
Despite recent advances,
outcomes remain dismal
in relapsed/refractory MCL
after initial therapies 3
• thrombocytopenia (17%)
Other frequently reported grade ≥3
AEs included infections (30%) and
diarrhea (3%).
Although study protocol required
CRS prophylaxis with dexamethasone
be given at the first CC-93269
dose, with dose increases in patients
receiving 6 mg or more, 23 patients
(77%) experienced CRS. Most cases of
CRS were grades 1 or 2 and occurred
ASHClinicalNews.org
Consult with an MCL expert to
discuss management options
References: 1. Cheminant M, Hermine O. Frontline therapy in mantle cell lymphoma: new standards in 2017. Am J Hematol Oncol. 2017;13(8):4-10.
2. Kumar A, Sha F, Toure A, et al. Patterns of survival in patients with recurrent mantle cell lymphoma in the modern era: progressive shortening in response
duration and survival after each relapse. Blood Cancer J. 2019;9(6):50. doi: 10.1038/s41408-019-0209-5. 3. Rule S, Dreyling M, Goy A, et al. Outcomes in
370 patients with mantle cell lymphoma treated with ibrutinib: a pooled analysis from three open-label studies. Br J Haematol. 2017;179(3):430-438.
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