By Fineline Cube 
US biotech giant Amgen (NASDAQ: AMGN) has announced positive results from the global Phase III DeLLphi-304 study for its Imdelltra (tarlatamab-dlle) in patients with small cell lung cancer (SCLC) who experienced disease progression after a single line of platinum-based chemotherapy. The study met its primary endpoint at a planned interim analysis, demonstrating a statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy.
Mechanism of Action and Innovation
Imdelltra is a DLL3/CD3-directed bispecific T-cell engager (BiTE) immunotherapy. It works by engaging T cells with DLL3-expressing tumor cells, inducing T-cell activation, inflammatory cytokine production, and cytotoxic protein release, leading to directed tumor cell lysis. This mechanism addresses a critical unmet need in the treatment of SCLC, particularly in patients with limited therapeutic options following disease progression.
Regulatory Milestones and Market Outlook
The drug received conditional approval in the UK in January 2024 for use in extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The positive results from the DeLLphi-304 study further strengthen the case for broader regulatory approvals globally, positioning Imdelltra as a promising new treatment option for patients with this aggressive form of lung cancer.-Fineline Info & Tech