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• W3136690647 abstract "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. Here we present population pharmacokinetics (popPK) and exposure-response (ER) analyses based on the interim analysis to support the recommended durvalumab fixed-dose regimen for treatment-naïve patients with extensive-stage (ES)-SCLC. Treatment-naïve patients (WHO performance status 0/1) with ES-SCLC received 4 cycles of durvalumab 1500 mg + EP q3w followed by maintenance durvalumab 1500 mg q4w until disease progression or up to 6 cycles of EP q3w and optional prophylactic cranial irradiation (investigator’s discretion). Pharmacokinetic (PK) data of durvalumab from CASPIAN were analysed using a previously developed popPK model, while key PK parameters were re-estimated with CASPIAN data. The effects of covariates, such as demographics and baseline disease characteristics, on the PK of durvalumab were evaluated. The model-predicted durvalumab exposure was correlated with observed efficacy and safety outcomes to explore ER relationships, including evaluation of potential confounding effects of baseline prognostic factors. The effect of body weight on efficacy and safety outcomes in patients treated with durvalumab + EP was also analysed. Of 265 patients treated with durvalumab + EP, 259 had ≥1 measurable durvalumab PK sample post-dose and were included in the popPK analysis. There were no clinically meaningful PK differences between durvalumab when given in combination with EP and previous data from durvalumab monotherapy studies. Covariate analysis suggested generally limited or no effects of body weight, race, age, gender or other covariates on durvalumab PK compared with overall PK variability. In total, 265 patients treated with durvalumab + EP were included in the exposure-efficacy and exposure-safety analyses. No clinically meaningful ER relationships were observed for efficacy or safety. Although a slightly longer median OS was observed in patients with the greatest exposure to durvalumab + EP (15.8 months in quartile 4 versus 11.6, 11.3 and 12.6 months, respectively, for quartiles 1, 2 and 3 of durvalumab AUCss), durvalumab exposure (AUCss and Cmin1) was not identified as a significant covariate (p >0.05) for OS when accounting for confounding baseline prognostic factors. Additionally, there was no clear impact of body weight (31–128 kg) on efficacy or safety in patients receiving durvalumab + EP. There was no meaningful impact of exposure or body weight (>30 kg) observed on either efficacy or safety in patients treated with a fixed-dose of 1500 mg durvalumab in CASPIAN. These results support the use of a 1500 mg fixed-dose of durvalumab in combination with EP for the treatment of patients with ES-SCLC." @default.
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• W3136690647 date "2021-03-01" @default.
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• W3136690647 title "P48.21 Population Pharmacokinetics and Exposure-Response with Durvalumab Plus Platinum-Etoposide in ES-SCLC: Results from CASPIAN" @default.
• W3136690647 doi "https://doi.org/10.1016/j.jtho.2021.01.891" @default.
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