POSEIDON (chemotherapy plus durvalumab and tremelimumab)
Trial question
What is the role of first-line tremelimumab plus durvalumab and chemotherapy in patients with metastatic non-small cell lung cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 675
675 patients (158 female, 517 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 tremelimumab plus durvalumab and chemotherapy (at a dose of 75 mg plus 1,500 mg and platinum-based chemotherapy, respectively, for up to four 21-day cycles, followed by durvalumab once every 4 weeks until progression and one additional tremelimumab dose)
N=337 chemotherapy (chemotherapy for up to six 21-day cycles with or without maintenance pemetrexed)
Primary outcome
Progression-free survival
6.2
4.8
6.2 months
4.7 months
3.1 months
1.6 months
0.0 months
Tremelimumab plus durvalumab and
chemotherapy
Chemotherapy
Significant
increase ▲
Significant increase in progression-free survival (6.2 months vs. 4.8 months; HR 1.38, 95% CI 1.16 to 1.66)
Secondary outcomes
Significant increase in overall survival (14 months vs. 11.7 months; HR 1.29, 95% CI 1.08 to 1.53)
Borderline significant increase in unconfirmed objective response rate (46.3% vs. 33.4%; OR 1.72, 95% CI 1.26 to 2.37)
Safety outcomes
No significant differences 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, tremelimumab plus durvalumab and chemotherapy were 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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