Implementation of tarlatamab treatment for small cell lung cancer using an outpatient care program.

Abstract

8106 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. Baseline demographics and clinical characteristics. n (%) Age (median, range) 64, 35-80 Gender Male: 11 (38%); Female:18 (62%) Primary site and histology SCLC: 25; Transformed EGFR mutant NSCLC: 3; Unknown primary site: 1 Race: Black: 14 (48%); White: 14 (48%); Unreported: 1 (3%) ECOG Performance status: 0: 4 (14%); 1: 20 (69%); 2: 5 (17%) Prior Lines of Therapy: 1: 9 (31%); 2: 9 (31%); 3: 7 (24%); 4: 4 (14%) Metastatic sites: Liver: 12 (41%); Brain: 17 (58%); Bone: 7 (24%) Duration of platinum sensitivity: < 90 days: 6 (21%); 90-180 days: 12 (41%); > 180 days: 11 (38%)