Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1
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Discussion
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Implication
Randomized trial demonstrates improved survival and lower toxicity with cancer vaccine OSE2101 in immunotherapy-resistant lung cancer, indicating therapeutic promise in secondary resistance.
Key Points
- To assess the efficacy and safety of the cancer vaccine OSE2101 compared to standard-of-care chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer resistant to immunotherapy.
- Open-label, randomized (2:1) phase III trial comparing OSE2101 against standard-of-care chemotherapy (docetaxel or pemetrexed) in HLA-A2-positive patients with advanced NSCLC who failed sequential or concurrent chemotherapy and immune checkpoint blockers.
- A total of N=219 patients were randomized (139 OSE2101, 80 chemotherapy) before accrual was terminated early during interim analysis due to COVID-19.
- In the overall population, median overall survival non-significantly favored OSE2101 over chemotherapy (HR 0.86, 95% CI 0.62–1.19, P=0.36).
- In patients with secondary resistance to immunotherapy (n=118), OSE2101 significantly prolonged median overall survival compared to chemotherapy (11.1 vs 7.5 months; HR 0.59, 95% CI 0.38–0.91, P=0.017).
- Grade ≥3 adverse events occurred significantly less frequently with OSE2101 than with chemotherapy (11.4% vs 35.1%, P=0.002).
Cite This Study
Besse et al. (2023) studied this question.