Friday, September 13, 2024 Late breaking results of the Canadian Cancer Trials Group (CCTG) BR31 study “A double-blind, placebo-controlled, randomized phase 3 trial of adjuvant durvalumab in completely resected non-small-cell lung cancer” were presented at the European Society for Medical Oncology (ESMO) Congress 2024. The trial tested whether there is a benefit to receiving adjuvant immunotherapy with the anti-PD-L1 targeting monoclonal antibody durvalumab after complete tumour resection and optional chemotherapy in early-stage (IB-IIIA) non-small cell lung cancer (NSCLC). The study did not meet its primary endpoint which was targeting a significant improvement in disease free survival in the population of patients whose tumours had a tumour cell PD-L1 score of 25% or greater and were EGFR/ALK wildtype. “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. Dr Goss further noted that, “Although there have been two other trials evaluating checkpoint inhibitors in a similar setting which have shown an improvement in disease free survival their impact on overall survival has been at best modest. We know that these agents are effective in improving overall survival in more advanced disease and our task moving forward is to understand the biology and to ask how best to integrate these agents in the earlier setting whilst limiting the toxicity experienced by patients.” Lung cancer, the second most common cancer in North America is the leading cause of death in both men and women. CCTG BR31 is the first trial to test the use of durvalumab as adjuvant therapy alone in the setting of early lung cancer. Researchers randomized 1415 patients 2:1 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 was led by CCTG, with 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), National Health and Medical Research Council (NHMRC) Clinical Trials Centre, the Dutch Society for Pulmonology and Tuberculosis (NVALT), Korean Cancer Study Group (KCSG) and the Central and East European Oncology Group (KEEOG). The results were presented as the LBA48 lead oral presentation in the Non-Metastatic NSCLC Session on Friday September 13th at the ESMO Congress 2024 in Barcelona. A special thank you AstraZeneca for their support of independent academic research. The trial was supported by the Canadian Cancer Society (CCS). Dr Glenwood Goss BR31trial chair Chris O'Callaghan, CCTG Senior Investigator
