P48.21 Population Pharmacokinetics and Exposure-Response with Durvalumab Plus Platinum-Etoposide in ES-SCLC: Results from CASPIAN

Y. Zheng, D. Jin, Y. Guan,M. Özgüroğlu,D. Trukhin,A. Poltoratskiy, Y. Chen, L. Havel,M. Hochmair, L. Paz-Ares,H. Jiang,J. Armstrong,C. Chen, Y.H. Liu, L. Roskos

Journal of Thoracic Oncology(2021)

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摘要
In the Phase 3 CASPIAN trial, first-line durvalumab in combination with etoposide and either cisplatin or carboplatin (EP) significantly improved overall survival (OS) versus EP alone at the planned interim analysis (data cutoff: 11 March 2019): hazard ratio 0.73 (95% confidence interval [CI] 0.59–0.91; p=0.0047). This OS benefit was sustained after >2 years of median follow-up (data cutoff 27 January 2020): hazard ratio 0.75 (95% CI 0.62‒0.91; nominal p=0.0032). Safety findings were consistent with the known safety profiles of the individual agents, and no patients developed treatment-emergent anti-drug antibodies to durvalumab.
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关键词
CASPIAN, population pharmacokinetics, Durvalumab
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