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The BR.31 lung cancer trial publication in the Journal of Clinical Oncology

Adjuvant durvalumab in completely resected non-small-cell lung cancer
Adjuvant durvalumab in completely resected non-small-cell lung cancer

The results of the BR.31 global Phase III study, testing adjuvant durvalumab in patients with completely resected non–small cell lung cancer (NSCLC) and led by Canadian Cancer Trials Group (CCTG), were published in the Journal of Clinical Oncology. 

“This trial tested the drug durvalumab, an immune checkpoint inhibitor which helps the body’s immune system recognize and attack cancer cells. These agents do not directly kill cancer cells but instead promote the immune system’s ability to fight and destroy cancer cells,” says the Canadian trial leader Dr Glenwood Goss, Emeritus Professor of Medicine and Senior Clinical Researcher at the Ottawa Hospital Research Institute and University of Ottawa. 

Lung cancer, the second most common cancer in North America is the leading cause of death in both men and women and NSCLC accounts for 80-85% of all lung cancer. 

The results indicated that adjuvant durvalumab did not significantly improve disease-free survival (DFS) compared with placebo in the primary study population. As a result, the study did not meet its primary endpoint, which was to demonstrate a significant improvement in DFS among patients whose tumours had a tumour cell PD-L1 expression of 25% or greater and were EGFR/ALK wild-type.

Dr Goss further noted that, “There have been two other trials evaluating checkpoint inhibitors in a similar setting which have shown an improvement in disease free survival. Despite their effectiveness in advanced disease, further research is needed to understand the biology and optimize the use of these agents in earlier disease while minimizing toxicity for patients.”

About the trial

The trial investigated the use of the drug durvalumab (Imfinzi) as an adjuvant treatment for patients with completely resected non-small cell lung cancer (NSCLC). 

Researchers randomized 1415 patients in a 2:1 design to receive either durvalumab or placebo following completed resection of all cancer and optional adjuvant chemotherapy. The trial was conducted at 269 sites in 19 countries via an international consortium of 10 academic cancer cooperative groups. 

The international study involved the invaluable collaboration from the Intergroupe Francophone de Cancerologie Thoracique (IFCT), the West Japan Oncology Group (WJOG), the Chinese Thoracic Oncology Group (CTONG), the National Cancer Institute Naples (NCI), the Spanish Lung Cancer Group (GECP), the Australasian Lung Cancer Trials Group (ALTG), the Australian National Health and Medical Research Council (NHMRC) Clinical Trials Centre, the Dutch Society for Pulmonology and Tuberculosis (NVALT), the Korean Cancer Study Group (KCSG) and the Central and East European Oncology Group (KEEOG). A special thank you to AstraZeneca for their support of independent academic research. The trial was also supported by the Canadian Cancer Society (CCS).

The primary results of the trial as published in JCO were presented as the lead oral presentation in the Non-Metastatic NSCLC Session at the ESMO Congress 2024 in Barcelona.