After complete resection of early-stage non-small cell lung cancer (NSCLC) and optimal chemotherapy, adjuvant durvalumab did not improve disease-free survival versus placebo in the international, double-blind, phase 3 BR.31 trial.
Adjuvant chemotherapy improves 5 year survival in completely resected stage I-IIB NSCLC; however, approximately 60% of patients still relapse and die of disease1. Adjuvant immunotherapy with atezolizumab recently demonstrated improvement in disease-free survival (DFS) with limited benefit on overall survival2.
The PD-L1 inhibitor durvalumab has proven efficacy as a peri-operative regimen in resectable NSCLC3. The Canadian Cancer Trials Group (CCTG) BR.31 trial (NCT02273375), conducted in 269 centers across 19 countries, aimed to evaluate the benefit of adjuvant durvalumab in early-stage, completely resected NSCLC. The primary endpoint was DFS in patients with PD-L1 greater than or equal to 25% EGFR–/ALK. Glenwood Goss, MD, from Ottawa Hospital, in Canada, presented the results4.
After optional adjuvant chemotherapy (in 85% of participants), 1,415 participants (stage I-IIIA) were randomly assigned to receive adjuvant durvalumab or placebo. After a median follow-up of 60 months, the primary endpoint was not met. Median DFS was 66.9 months (95% CI 57.6–NR) versus 60.2 months (95% CI 47.7–NR) in the durvalumab arm and placebo arm (HR 0.90; P=0.624). In addition, no benefit of adjuvant durvalumab was demonstrated in participants with PD-L1 greater than or equal to 1% EGFR–/ALK–, nor in PDL all-comers/EGFR–/ALK–. Safety data were in line with results from previous trials.
Based on these outcomes, Prof. Goss concluded that “after complete resection and optimal chemotherapy, adjuvant durvalumab does not improve DFS versus placebo.”
Medical writing support was provided by Marten Dooper.
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