DUO-E (durvalumab)
Trial question
What is the role of carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab in patients with advanced or recurrent endometrial cancer?
Study design
Multi-center
Double blinded
RCT
Population
479 female patients.
Inclusion criteria: patients with newly diagnosed advanced or recurrent endometrial cancer.
Key exclusion criteria: history of leptomeningeal carcinomatosis; brain metastases or spinal cord compression; prior treatment with poly (ADP-ribose) polymerase inhibitors; any prior exposure to immune-mediated therapy.
Interventions
N=238 durvalumab maintenance (carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab plus olaparib placebo).
N=241 placebo maintenance (carboplatin/paclitaxel plus durvalumab placebo followed by placebo maintenance).
Primary outcome
Median progression-free survival
10.2 months
9.6 months
10.2 months
7.6 months
5.1 months
2.5 months
0.0 months
Durvalumab
maintenance
Placebo
maintenance
Significant
increase ▲
Significant increase in median progression-free survival (10.2 months vs. 9.6 months; HR 1.41, 95% CI 1.12 to 1.75).
Secondary outcomes
No significant difference in interim overall survival (72.7% vs. 66%; HR 1.3, 95% CI 0.93 to 1.79).
Significant increase in median progression-free survival in the MMR proficient subgroup (9.9 months vs. 9.7 months; HR 1.3, 95% CI 1.03 to 1.67).
Significant increase in median progression-free survival in the PD-L1-positive subgroup (11.3 months vs. 9.5 months; HR 1.59, 95% CI 1.2 to 2.08).
Safety outcomes
No significant difference in adverse event.
Conclusion
In patients with newly diagnosed advanced or recurrent endometrial cancer, durvalumab maintenance was superior to placebo maintenance with respect to median progression-free survival.
Reference
Shannon N Westin, Kathleen Moore, Hye Sook Chon et al. Durvalumab Plus Carboplatin / Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial. J Clin Oncol. 2024 Jan 20;42(3):283-299.
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