In a phase III trial (Canadian Cancer Trials Group BR.31) reported in the Journal of Clinical Oncology, Goss et al found that adjuvant durvalumab did not improve disease-free survival vs placebo in patients with completely resected early-stage non–small cell lung cancer (NSCLC).
Study Details
In the international double-blind trial, patients with no common activating EGFR mutations and no ALK gene rearrangements were randomly assigned 2:1 to receive durvalumab at 20 mg/kg (n = 815) or placebo (n = 404) once every 4 weeks for 12 cycles after complete resection. Patients could receive optional adjuvant platinum-based chemotherapy, and those with N2 disease could receive optional postoperative radiotherapy. The primary analysis population consisted of 316 vs 161 patients with tumor cell (TC) PD-L1 expression ≥ 25%. Secondary analysis populations consisted of 469 vs 240 patients with TC PD-L1 expression ≥ 1% and the total EGFR-negative/ALK-negative population. The primary endpoint was investigator-assessed disease-free survival.
Key Findings
In the EGFR-negative/ALK-negative population with TC PD-L1 expression ≥ 25%, median disease-free survival was 69.9 months (95% confidence interval [CI] = 57.6% to not reached) in the durvalumab group vs 60.2 months (95% CI = 47.7 months to not reached) in the placebo group (stratified hazard ratio [HR] = 0.93, 95% CI = 0.71–1.25, P = .64).
In the EGFR-negative/ALK-negative population with TC PD-L1 expression ≥ 1%, median disease-free survival was 59.9 months (95% CI = 48.4–77.9 months) in the durvalumab group vs 60.3 months (95% CI = 43.8–80.9 months) in the placebo group (HR = 0.99, 95% CI = 0.79–1.25, P = .93). In the total EGFR-negative/ALK-negative population, median disease-free survival was 60.0 months (95% CI = 49.6–77.9 months) in the durvalumab group vs 53.9 months (95% CI = 36.7–67.3 months) in the placebo group (HR = 0.89, 95% CI = 0.75–1.07, P = .21).
Grade 3 to 4 adverse events occurred in 26% of the total durvalumab group vs 20% of the placebo group; 13.9% vs 3.7% were considered at least possibly related to treatment. Serious adverse events occurred in 20.8% vs 15.6% of patients. Death considered at least possibly related to treatment occurred in six patients in the durvalumab group and none in the placebo group.
The investigators concluded: “Adjuvant durvalumab following complete resection was not associated with improvement in [disease-free survival] compared with placebo in [EGFR-negative/ALK-negative] NSCLC, regardless of PD-L1 status.”
Glenwood D. Goss, MD, FCP(SA), FRCPC, of Division of Medical Oncology, University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Canada, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by the Canadian Cancer Society and AstraZeneca. For full disclosures of the study authors, visit ascopubs.org.
