ADRIATIC Study Shows Durvalumab Boosts Survival in Limited-Stage SCLC
David Spigel, MD, discusses the findings from and methodology behind the ADRIATIC study of durvalumab as consolidation therapy for patients with limited-stage small cell lung cancer.
David Spigel, MD, chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, discusses the findings from and methodology behind the ADRIATIC study (NCT03703297) of durvalumab (Imfinzi) as consolidation therapy for patients with limited-stage small cell lung cancer (SCLC) that had not worsened after standard chemoradiotherapy.
According to data from the first planned analysis of the trial presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, durvalumab significantly improved overall survival and progression-free survival vs placebo when given as a treatment for patients with limited-stage SCLC. For safety, the adverse events observed in the study were similar between the durvalumab and placebo groups.
Transcription:
0:10 | This was a large trial. It was a randomized, phase 3, double-blind, placebo-controlled trial run around the world. The patients were randomized to get durvalumab after chemoradiation, durvalumab, and placebo, or a combination of durvalumab and a CTLA4 antibody, tremelimumab.
0:34 | The analysis we presented [at ASCO] was the first planned interim analysis of the primary end points for durvalumab vs placebo. That analysis had 2 primary end points: overall survival and progression-free survival by blinded independent central review. There are additional analyses planned for the tremelimumab arm, as well as things like quality-of-life and other safety end points. Those will come out, specifically the tremelimumab comparison, with a later interim analysis.
1:13 | The study met both of its primary end points. Durvalumab improved overall survival with a hazard ratio of 0.73 that corresponds to a 27% reduction in the risk of death compared with placebo. The median survival was improved by approximately 2 years. So, a 22.5-month improvement in median overall survival with durvalumab. [For] the second primary end point, progression-free survival, the hazard ratio for benefit with durvalumab was 0.76, a 24% reduction in the risk of death or progression. That corresponded to an advantage of 7.4 months in median progression-free survival. It was fantastic that both primary end points were met.
