Carlisle J. W., O'reilly K., Canaslan K., Li X. (., Switchenko J. M., Steuer C. E., ...More
2025 ASCO Annual Meeting, Illinois, United States Of America, 30 May - 04 June 2025, pp.8106, (Full Text)
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Publication Type:
Conference Paper / Full Text
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Doi Number:
10.1200/jco.2025.43.16_suppl.8106
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City:
Illinois
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Country:
United States Of America
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Page Numbers:
pp.8106
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Dokuz Eylül University Affiliated:
Yes
Abstract
Background: Tarlatamab, a bispecific T-cell engager targeting DLL3, was FDA approved for
relapsed small cell lung cancer (SCLC) in May 2024. It requires observation for 24 hours for the
first two doses due to the risk of Cytokine Release Syndrome (CRS). We developed an outpatient
program to administer tarlatamab at the Winship Cancer Institute and describe the initial
experience in this report. Methods: Patients received tarlatamab in the outpatient infusion
center then were observed in an outpatient oncology Immediate Care Center (ICC) onsite,
staffed by advanced practice providers, to complete the 24-hour monitoring for CRS and
immune effector cell-associated neurotoxicity (ICANS). Vital signs and ICE scores were monitored, and patients were hospitalized with . grade 2 CRS or grade 1 ICANS based on American
Society for Transplantation and Cellular Therapy Consensus Grading. Patients were prescribed
dexamethasone 8mg to be taken at physician direction for later-onset symptoms prior to return
to a health care facility. Demographics, disease characteristics, treatment history, toxicities,
and outcomes were abstracted from the electronic medical record. Results: From June 2024 to
January 2025, 29 patients with SCLC were treated, 27 of whom completed cycle 2 at data cut-off
and were evaluated for safety and efficacy. Baseline demographics and clinical characteristics
are shown in Table 1. Four patients were admitted prophylactically based on limited home
support, distance from home, or location of administration; 6 patients required admission from
the ICC during the first two cycles due to CRS/ICANS (CRS: 1, ICANS:1, both: 4) and one patient
was admitted 48 hours after C1D8 for grade 1 CRS and nausea. CRS was observed 14 patients
(grade 1: 7, grade 2: 4, grade 3: 3) and ICANS was observed in 10 patients (grade 1: 3, grade 2: 4,
grade 3: 3). Eight patients required dose holds, with two who reinitiated step up dosing.
Investigator-assessed radiographic responses included 9 partial response, 7 stable disease,
6 progressive disease, and 5 not evaluable. With a median duration of follow-up of 133 days
(95% CI 91,168), the estimated median progression free survival was 101 days (95% CI 78, NA).
Conclusions: Outpatient administration of tarlatamab is safe and feasible with appropriate
monitoring, including for patients with an ECOG performance status of 2.