IMDELLTRA® IN COMBINATION WITH IMFINZI® DEMONSTRATED LANDMARK IMPROVEMENT IN OVERALL SURVIVAL IN FIRST-LINE EXTENSIVE STAGE SMALL CELL LUNG CANCER
Amgen's Phase 3 DeLLphi-305 study met its primary endpoint at a pre-specified interim analysis, showing a statistically significant and clinically meaningful overall survival improvement for IMDELLTRA (tarlatamab-dlle) plus AstraZeneca's Imfinzi (durvalumab) versus durvalumab alone as first-line maintenance in extensive stage small cell lung cancer. The 563-patient trial also met secondary progression-free survival and objective response rate endpoints, with a safety profile consistent with the known profiles of the individual medicines and no new safety signals.
Key figures
- Drug Name
- IMDELLTRA (tarlatamab-dlle)
- Phase Of Trial
- Phase 3
- Setting
- first-line maintenance, extensive stage small cell lung cancer (ES-SCLC)
- Comparator
- durvalumab alone
- Trial name
- DeLLphi-305
- Randomization
- 1:1
- Safety signal
- profile consistent with known profiles of individual medicines; no new or unexpected safety signals
- Primary endpoint
- overall survival (met at pre-specified interim analysis)
- Enrolled patients
- 563
- Secondary endpoints met
- ["progression-free survival (PFS)","objective response rate (ORR)"]
- Global lung cancer cases annual
- more than 2.6 million
- Sclc share of lung cancer cases
- 13-15%
- Benchmark median survival firstline maintenance
- approximately one year
AI analysis
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