AMGN · News · 20260908N

IMDELLTRA Lung Cancer Results

AMGEN INC · 2026-09-08 · Importance 34 · Surprise 42

Amgen reported positive Phase III DeLLphi-305 results for IMDELLTRA (tarlatamab-dlle) combined with AstraZeneca's Imfinzi (durvalumab) in first-line extensive-stage small cell lung cancer. The combination produced a statistically significant and clinically meaningful overall-survival improvement versus durvalumab alone and also met progression-free-survival and objective-response-rate endpoints. Amgen said the study was the first to show an overall-survival benefit for a BiTE therapy in the first-line maintenance setting for extensive-stage small cell lung cancer.

Key facts

• Amgen announced Phase 3 DeLLphi-305 met its primary endpoint at a pre-specified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in overall survival with IMDELLTRA in combination with Imfinzi versus durvalumab alone. source
• The DeLLphi-305 study also met secondary progression-free survival and objective response rate endpoints and showed a safety profile consistent with known individual medicine profiles. source
• Amgen announced IMDELLTRA in combination with Imfinzi is the first Bispecific T-cell Engager (BiTE) therapy to show an overall survival benefit in the first-line maintenance setting for extensive stage small cell lung cancer. source