Tarlatamab for patients with small cell lung cancer: 6-8 hour outpatient vs 48 hour inpatient monitoring in cycle 1
Recommended Citation
Chiang AC, Olmedo Garcia ME, Carlisle J, Dowlati A, Reguart N, Felip E, Jost PJ, Steeghs N, Stec R, Gadgeel S, Loong HH, Jiang W, Hamidi A, Parkes A, Paz-Ares L. Tarlatamab for patients with small cell lung cancer: 6-8 hour outpatient vs 48 hour inpatient monitoring in cycle 1. Immuno-Oncology Technol 2024; 24.
Document Type
Conference Proceeding
Publication Date
12-1-2024
Publication Title
Immuno-Oncology Technol
Abstract
Background: Tarlatamab, a bispecific T-cell engager (BiTE®) immunotherapy targeting delta-like ligand 3, has shown promising outcomes in previously treated small cell lung cancer (SCLC). We evaluated the safety of a reduced 6-8 hour (h) monitoring period with tarlatamab in an outpatient setting in the phase 1 DeLLphi-300 study. Methods: Patients (pts) with previously treated SCLC were enrolled in Part F evaluating 6-8 h outpatient monitoring for cycle 1 doses and received tarlatamab 10 mg Q2W dosing (1 mg on day 1, 10 mg on day 8 and 15 of cycle 1, and Q2W thereafter). Pts needed a caregiver and remained within 1 h of study site or affiliated hospital for 72 h post-dose. Clinic visits on days 2, 3, 5, 9, 16, and 22 were required to mitigate risk of underreporting adverse events (AEs). The primary endpoint was safety and tolerability. Safety outcomes were compared to pts from Part A cohorts who received tarlatamab 10 mg Q2W dosing with 48 h inpatient monitoring for cycle 1 doses. AEs were classified per CTCAE v4.0 and cytokine release syndrome (CRS) graded per Lee DW et al, Blood 2014. Results: A total of 88 pts (66 years median age; 51% male; median 2 prior lines of therapy) were enrolled, including 30 in the outpatient group and 58 in the inpatient group. The outpatient vs inpatient groups had a similar incidence of treatment-related AEs (93% vs 100%) and serious AEs (20% vs 29%). CRS incidence and time to resolution were similar between groups (Table 1). In the outpatient group, 18 pts had 25 cycle 1 CRS events, all of which resolved. Of the 25 CRS events, 5 events required hospitalization and 2 events involved an emergency room visit. Immune effector cell–associated neurotoxicity syndrome was rare (outpatient: 3.3%; inpatient: 3.4%). The hospitalization rate for any AE in cycle 1 was similar between groups. [Formula presented] Conclusions: There were no major differences in safety outcomes following tarlatamab administration with 6-8 h outpatient versus 48 h inpatient monitoring in cycle 1. Clinical trial identification: NCT03319940.
Volume
24
