AstraZeneca announced that positive results from the ADRIATIC Phase III trial showed AstraZeneca?s IMFINZI (durvalumab) ?demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to placebo for patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following standard-of-care concurrent chemoradiotherapy (cCRT). These results will be presented on June 2, 2024 during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #LBA5). Results from the planned interim analysis showed IMFINZIreduced the risk of death by 27% versus placebo (based on an OS hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.57-0.93; p=0.0104).

Estimated median OS was 55.9 months for IMFINZI versus 33.4 months for placebo. An estimated 57% of patients treated with IMFINZI were alive at three years compared to 48% on placebo. IMFINZI also reduced the risk of disease progression or death by 24% (based on a PFS HR of 0.76; 95% CI 0.61-0.95; p=0.0161) versus placebo.

Median PFS was 16.6 months for IMFINZI versus 9.2 months for placebo. An estimated 46% of patients treated with IMFINZI had not experienced disease progression at two years compared to 34% on placebo. The OS and PFS benefits observed were generally consistent across key prespecified patient subgroups including age, sex, race, disease stage1 at diagnosis, prior radiation and whether patients received prophylactic cranial irradiation.

The safety profile for IMFINZI was generally manageable and consistent with the known profile of this medicine. No new safety signals were observed. Grade 3 and 4 adverse events due to any cause occurred in 24.4% of patients treated with IMFINZI and 24.2% of patients treated on placebo.