POSEIDON (chemotherapy plus durvalumab)
Trial question
What is the role of first-line durvalumab plus chemotherapy in patients with metastatic non-small cell lung cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 675
675 patients (174 female, 501 male).
Inclusion criteria: adult patients with EGFR/ALK wild-type metastatic non-small cell lung cancer.
Key exclusion criteria: mixed small cell lung cancer and non-small cell lung cancer histology; autoimmune or inflammatory disorders; brain metastases or spinal cord compression; active infection.
Interventions
N=338 durvalumab plus chemotherapy (at a dose of 1,500 mg and platinum-based chemotherapy for up to four 21-day cycles, followed by durvalumab once every 4 weeks until progression).
N=337 chemotherapy (chemotherapy for up to six 21-day cycles with or without maintenance pemetrexed).
Primary outcome
Progression-free survival
5.5 months
4.8 months
5.5 months
4.1 months
2.8 months
1.4 months
0.0 months
Durvalumab plus
chemotherapy
Chemotherapy
Significant
increase ▲
Significant increase in progression-free survival (5.5 months vs. 4.8 months; HR 1.35, 95% CI 1.12 to 1.61).
Secondary outcomes
No significant difference in overall survival (13.3 months vs. 11.7 months; HR 1.16, 95% CI 0.98 to 1.38).
Significant increase in unconfirmed objective response rate (48.5% vs. 33.4%; OR 1.9, 95% CI 1.38 to 2.62).
Safety outcomes
No significant difference in adverse events; grade 3/4 treatment-related adverse events.
Conclusion
In adult patients with EGFR/ALK wild-type metastatic non-small cell lung cancer, durvalumab plus chemotherapy was superior to chemotherapy with respect to a progression-free survival.
Reference
Melissa L Johnson, Byoung Chul Cho, Alexander Luft et al. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study. J Clin Oncol. 2023 Feb 20;41(6):1213-1227.
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