The delta-like ligand 3 (DLL3)–targeting half-life extended bispecific T-cell engager AMG 757 showed an “acceptable” safety profile and preliminary evidence of efficacy in patients with small-cell lung cancer (SCLC) in interim results from a first-in-humans Phase 1 dose-escalation study presented at the virtual European Lung Cancer Congress in March.

Among 52 enrolled patients with a median age of 64 and a median of two prior lines of therapy, seven (14%) achieved a confirmed partial response (PR) at dosage levels ranging from 1 mg to 10 mg. One patient had an unconfirmed PR at a dosage level of 30 mg. Twelve patients (24%) achieved stable disease. The median time to response was 1.8 months. In more than 83% of patients with a confirmed PR, the estimated duration of response was more than 6 months.

Cytokine release syndrome (CRS) was the most common adverse event, said Fiona H. Blackhall, MD, a study author and chair in thoracic oncology at the University of Manchester in the United Kingdom. CRS occurred in 44% of patients, most often in cycle 1, did not recur, and was typically mild and manageable with supportive care, corticosteroids, or anti-IL-6R. The maximum tolerated dose of AMG 787 had not yet been reached.    

• Paz-Ares L, Owonikoko TK, Johnson M, et al. Phase 1 study of AMG 757, a delta-like ligand 3 (DLL3) targeting, half-life extended BiTE (bispecific T-cell engager) immuno-oncology therapy, in small cell lung cancer. Journal of Thoracic Oncology (2021) 16 (suppl_4): S720-S728.
• Mauro G. AMG 757 Shows Early Efficacy, Safety in Small-Cell Lung Cancer. 2021 March 26. OncLive.com. https://www.onclive.com/view/amg-757-shows-early-efficacy-safety-in-small-cell-lung-cancer

Tags: cancer, cell therapy, Small cell, lung cancer, early signals, safety, AMG 787