Adjuvant Durvalumab in Completely Resected Early-Stage Non-Small Cell Lung Cancer

Area of Science:

• Oncology
• Immunotherapy
• Thoracic Surgery

Background:

• Adjuvant immunotherapy has shown promise in resected non-small cell lung cancer (NSCLC).
• However, previous trials have yielded conflicting results regarding its efficacy.
• The Canadian Cancer Trials Group BR.31 trial specifically investigated adjuvant durvalumab.

Purpose of the Study:

• To evaluate the efficacy of adjuvant durvalumab in patients with completely resected early-stage NSCLC.
• To assess disease-free survival (DFS) as the primary endpoint.
• To analyze secondary outcomes including overall survival (OS) and adverse events.

Main Methods:

• 1,415 patients with resected stage IB to IIIA NSCLC were randomized 2:1 to receive durvalumab or placebo for 12 cycles.
• Stratification included stage, nodal dissection, PD-L1 expression, chemotherapy use, and center.
• Primary analysis focused on patients with PD-L1 tumor cell expression ≥25%, and no EGFR or ALK mutations (EGFR-/ALK-).

Main Results:

• No significant difference in DFS was observed between durvalumab and placebo groups in the primary (HR 0.93; P=.64) or secondary EGFR-/ALK- populations.
• Median follow-up was 60 months.
• Grade 3-4 adverse events were more frequent in the durvalumab group (26%) compared to placebo (20%).

Conclusions:

• Adjuvant durvalumab following complete resection did not improve DFS in EGFR-/ALK- NSCLC patients.
• Efficacy was not improved regardless of PD-L1 expression status.
• The study did not support the use of adjuvant durvalumab in this patient population.