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• W2892337223 abstract "9057 Background: Treatment with anti-PD-1 therapy is subject to large inter-individual variation in clinical outcome. This may be influenced partly by differences in nivolumab exposure between patients. The objective of the current analysis was to investigate whether an exposure-response relationship exists for nivolumab-treated NSCLC patients. Methods: 84 patients started nivolumab treatment between May 5th 2016 and August 1st 2017 and were included for prospective collection of serum samples prior to each nivolumab cycle. Clinical data were collected until November 1st 2017. Patients were classified according to best objective response (BOR) according to RECIST v1.1 and the occurrence of grade ≥3 toxicities according to CTCAE v4.03. Geometric mean nivolumab trough concentrations after 2, 4, and 10 weeks of treatment were compared using ANOVA with respect to BOR and t-test with respect to toxicity in patients without dose delays until that particular time point. Results: 76 patients were evaluable for analysis; 4 patients had no follow-up tumor evaluation, and 4 patients had no follow-up blood sample. At each time point, partial responders (PR; n = 15) had higher geometric mean trough concentrations when compared to patients with progression (PD; n = 33): at 2 weeks : 27.4 µg/mL (95% CI: 22.3 – 33.6 µg/mL) vs. 18.7 µg/mL (95% CI: 16.7 – 20.9 µg/mL; p = 0.001; 47% higher), at 4 weeks: 46.2 µg/mL (95% CI: 37.4 – 57.0 µg/mL) vs. 30.2 µg/mL (95% CI: 25.0 – 36.4 µg/mL; p = 0.008; 53% higher), at 10 weeks: 79.4 µg/mL (95% CI: 60.7 – 103.8 µg/mL) vs. 45.8 µg/mL (95% CI: 35.6 – 58.9 µg/mL; p = 0.002; 73% higher). Moreover, PR patients had higher trough concentrations when compared to patients with stable disease (SD; n = 28) at week 2 (p = 0.034) and at week 4 (p = 0.047). Exposure was not significantly related to the occurrence of grade ≥3 toxicity (n = 15) at any time point. Conclusions: This analysis shows that NSCLC patients with an objective response to nivolumab have significantly higher nivolumab exposure than patients with early progressive disease, indicating an exposure-response relationship. Further clinical research is needed to explain and quantify this relation. If confirmed, more rational and individualized dosing-strategies can improve patient outcome." @default.
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• W2892337223 date "2018-05-20" @default.
• W2892337223 modified "2023-10-12" @default.
• W2892337223 title "Correlation between nivolumab exposure and treatment outcome in NSCLC." @default.
• W2892337223 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.9057" @default.
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