2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.08F.05 Real World Evidence of Long-Term Safety and Effectiveness of Durvalumab in Unresectable Stage III NSCLC in Japan: AYAME Study

EP.08F.05 Real World Evidence of Long-Term Safety and Effectiveness of Durvalumab in Unresectable Stage III NSCLC in Japan: AYAME Study

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The AYAME study investigates the long-term safety and effectiveness of durvalumab, a consolidation therapy recommended after chemoradiation therapy (CRT) for patients with unresectable stage III non-small cell lung cancer (NSCLC), in a real-world setting in Japan. The PACIFIC trial established durvalumab's safety during the treatment period, but its long-term safety and effectiveness remained under-evaluated, especially regarding adverse events like interstitial lung disease (ILD), which the Japanese subgroup in the PACIFIC trial primarily experienced.<br /><br />The study enrolled 529 patients from 52 sites between July 2019 and December 2020, with a follow-up period of up to three years. The primary objectives included evaluating the incidence of ILD and other adverse events within three years of starting durvalumab, alongside monitoring progression-free survival (PFS) and overall survival (OS) rates.<br /><br />Results indicated that the incidence and severity of ILD were similar to the Japanese subset of the PACIFIC trial, with no new ILD-related safety signals emerging. The median PFS was reported at 23.2 months, and PFS rates at 12, 24, and 36 months were 62.5%, 49.4%, and 40.4%, respectively. The median OS was not reached, while OS rates at 24 and 36 months were 75.5% and 65.6%, respectively.<br /><br />Multivariate analysis identified increased V20, V5 levels, and the presence of Grade 1 ILD before durvalumab administration as risk factors for developing more severe ILD. The study strengthens real-world evidence of durvalumab's role as a standard care treatment, showing comparable safety and effectiveness to clinical trial settings in treating unresectable stage III NSCLC. The collaboration between the Japanese Lung Cancer Society and AstraZeneca highlights the study's significant contributions to lung cancer treatment research.

Asset Subtitle

Nobuyuki Yamamoto

Meta Tag

Speaker Nobuyuki Yamamoto

Topic Local-Regional Non-small Cell Lung Cancer

Keywords

AYAME study

durvalumab

consolidation therapy

non-small cell lung cancer

interstitial lung disease

real-world setting

progression-free survival

overall survival

Japanese Lung Cancer Society

AstraZeneca