Incidence, onset, and management of myelosuppression in patients treated with loncastuximab tesirine for R/R DLBCL in a pooled safety analysis
Solh, M. Alderuccio, J. P. Hess, B. Radford, John A Lunning, M. Ungar, D. Burke, M. Wang, L. Q. Ardeshna, K.
Solh, M.
Alderuccio, J. P.
Hess, B.
Radford, John A
Lunning, M.
Ungar, D.
Burke, M.
Wang, L. Q.
Ardeshna, K.
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Abstract
Context: Loncastuximab tesirine (lonca) is a novel antibody-drug
conjugate comprising an anti-CD19 antibody conjugated to a potent
pyrrolobenzodiazepine dimer cytotoxin, indicated for treatment of
relapsed/refractory DLBCL after ≥2 systemic treatments . Objective:
Characterize the occurrence and management of neutropenia,
thrombocytopenia, and anemia in patients with relapsed/refractory
DLBCL treated with lonca monotherapy. Methods: Patients with
relapsed/refractory DLBCL in the completed phase 1 LOTIS-1 trial (NCT02669017) and the ongoing pivotal phase 2 LOTIS-2
(NCT03589469; data cutoff 06 August 2020) trial received lonca
IV every 3 weeks. The LOTIS-1 study used doses ranging from
0.015 to 0.2 mg/kg, while the LOTIS-2 study used the labeled dose
of 0.15 mg/kg for 2 doses followed by 0.075 mg/kg for subsequent
doses. Growth factor was allowed, according to ASCO guidelines.
Incidence of hematologic abnormalities was based on laboratory
reporting, while therapy modifi cation was based on adverse event
reporting. A pooled safety population of patients treated with
an initial dose of 0.15 mg/kg was analyzed. Results: Grade 3/4
neutropenia occurred in 32.1% (n=69), thrombocytopenia in
20.0% (n=43), and anemia in 12.6% (n=27, all grade 3) of patients.
Most patients with grade 3/4 anemia and thrombocytopenia had
onset within the fi rst 2 months, by treatment cycle 4. Most patients
with grade 3/4 neutropenia had onset within the fi rst 4 months, by
treatment cycle 7. Dose delay occurred due to grade 3/4 neutropenia
in 10.2% (n=22), grade 3/4 thrombocytopenia in 8.4% (n=18), and
in 10.2% (n=22), grade 3/4 thrombocytopenia in 8.4% (n=18), and
grade 3 anemia in 1.4% (n=3) of patients. Dose reduction occurred
due to grade 3/4 thrombocytopenia in 0.5% (n=1) of patients and
due to grade 3/4 neutropenia in 0.5% (n=1) of patients. No dose
reductions occurred due to anemia. Treatment discontinuation
occurred due to grade 3/4 thrombocytopenia in 2.3% (n=5) of
patients and due to grade 3/4 neutropenia in 0.5% (n=1) of patients.
No treatment discontinuations occurred due to anemia. Febrile
neutropenia occurred in 3.3% (n=7) of patients. Conclusions: The
incidence of grade ≥3 myelosuppression with lonca was moderate.
Most myelosuppression events were manageable with dose delays
and did not result in dose reduction or treatment discontinuation.
Description
Date
2021
Publisher
Collections
Keywords
Type
Other
Citation
Solh M, Alderuccio JP, Hess B, Radford J, Lunning M, Ungar D, et al. Incidence, Onset, and Management of Myelosuppression in Patients Treated with loncastuximab Tesirine for R/R DLBCL in a Pooled Safety Analysis. Clinical Lymphoma Myeloma & Leukemia. 2021;21:S394-S5.