AEGEAN
Trial question
What is the role of perioperative durvalumab in patients with resectable non-small cell lung cancer?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 740
740 patients (210 female, 530 male)
Inclusion criteria: patients with resectable non-small cell lung cancer
Key exclusion criteria: history of allogeneic organ transplantation; autoimmune or inflammatory disorders; another primary malignancy; active primary immunodeficiency; active infection; brain metastases or spinal cord compression
Interventions
N=366 durvalumab (platinum-based chemotherapy plus durvalumab 1,500 mg IV every 3 weeks for 4 cycles before surgery, followed by 1,500 mg durvalumab IV every 4 weeks for 12 cycles)
N=374 placebo (platinum-based chemotherapy plus matching placebo IV every 3 weeks for 4 cycles before surgery, followed by matching placebo IV every 4 weeks for 12 cycles)
Primary outcome
Event-free survival at 12 months
73.4
64.5
73.4 %
55.1 %
36.7 %
18.4 %
0.0 %
Durvalumab
Placebo
Significant increase ▲
NNT = 11
Significant increase in event-free survival at 12 months (73.4% vs. 64.5%; HR 1.47, 95% CI 1.14 to 1.89)
Secondary outcomes
Significant increase in pathological complete response (17.2% vs. 4.3%; AD 13%, 95% CI 8.7 to 17.6)
Significant increase in major pathological response (33.3% vs. 12.3%; AD 21%, 95% CI 15.1 to 26.9)
Safety outcomes
No significant difference in adverse events including grade 3-4 adverse events.
Conclusion
In patients with resectable non-small cell lung cancer, durvalumab was superior to placebo with respect to a event-free survival at 12 months.
Reference
John V Heymach, David Harpole, Tetsuya Mitsudomi et al. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 2;389(18):1672-1684.
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