ADRIATIC Trial: Durvalumab Redefines Limited-Stage SCLC Treatment

David Spigel, MD, chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, discusses the significant benefits of durvalumab (Imfinzi) as consolidation therapy following standard chemoradiotherapy for patients with limited-stage small cell lung cancer (SCLC), based on findings from the ADRIATIC study (NCT03703297).¹

The ADRIATIC trial is a phase 3 trial that randomly assigned patients with limited-stage SCLC, who had not progressed after chemoradiotherapy, to receive durvalumab, durvalumab plus tremelimumab (Imjudo), or placebo.

The results revealed a marked improvement in both overall survival (OS) and progression-free survival (PFS) with durvalumab compared to placebo. Durvalumab reduced the risk of death by 27% vs placebo (HR, 0.73; 95% CI, 0.57-0.93, P =.0104). The estimated median OS was 55.9 months (95% CI, 37.3-not estimable) with durvalumab vs 33.4 months with placebo (95% CI, 25.5-39.9). Further, durvalumab resulted in an estimated 57% of patients still alive at 3 years vs 48% of patients on placebo.

Spigel emphasizes that these findings establish a new standard of care. “Chemotherapy and radiation should continue to be the core treatment,” he states, “but after that, patients should receive up to 2 years [of monthly] durvalumab.”

Regarding safety, the study reported expected adverse events, primarily related to the preceding chemoradiotherapy, with approximately 23% of patients in each arm experiencing radiation pneumonitis. Durvalumab-related adverse events, such as mild pneumonitis, skin, and thyroid disorders, were consistent with those observed in other durvalumab trials and were generally low-grade. Importantly, no new or unexpected safety signals were identified.

The ADRIATIC trial's findings represent a significant advancement in the management of limited-stage SCLC. These data also led to the agent’s FDA approval in December 2024, for the treatment of patients with limited-stage SCLC whose disease has not progressed following platinum-based concurrent chemotherapy.²

REFERENCES:

1. Spigel D, Cheng Y, Cho B, et al. ADRIATIC: durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). J Clin Oncol 42, 2024 (suppl 17; abstr LBA5) doi:10.1200/JCO.2024.42.17_suppl.LBA5

2. FDA approves durvalumab for limited-stage small cell lung cancer. News release. FDA. December 4, 2024. Accessed April 7, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer?utm_medium=email&utm_source=govdelivery