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Poster display

3890 - Evaluation of the interindividual variability in plasma nivolumab level in non-small-lung cancer outpatients: preliminary results


10 Oct 2016


Poster display


Alicja Puszkiel


Annals of Oncology (2016) 27 (6): 526-544. 10.1093/annonc/mdw392


A. Puszkiel1, G. Noé2, P. Boudou-Rouquette3, C. Le Cossec4, J. Arrondeau3, J.S. Giraud1, J. Alexandre3, M. Vidal5, F. Goldwasser3, B. Blanchet1

Author affiliations

  • 1 Functional Unit Of Pharmacokinetics And Pharmacochemistry, Hôpital Cochin, 75014 - Paris/FR
  • 2 Umr 8638 Cnrs, Paris Descartes University, 75006 - Paris/FR
  • 3 Department Of Medical Oncology, Cochin Hospital, Paris Descartes University, Ap­hp, Carpem, Certim, Hôpital Cochin, 75014 - Paris/FR
  • 4 Domu, Assistance Publique - Hopitaux De Paris, Paris/FR
  • 5 Functional Unit Of Pharmacokinetics And Pharmacochemistry, Paris Descartes University, Umr 8638 Cnrs, Hôpital Cochin, 75014 - Paris/FR


Abstract 3890


Nivolumab, an anti PD-1 inhibitor, has been approved for the treatment of previously treated advanced or metastatic non-small-cell-lung cancer (NSCLC). The response rate is about 20% with nivolumab. The inter-patient variability in clinical outcomes to nivolumab is large and could be influenced by its pharmacokinetics. However, no data is currently available about the inter-patient variability in plasma exposure to nivolumab in NSCLC outpatients. The aim was to investigate the inter-patient variability in plasma level of nivolumab from 27 NSCLC outpatients.


NSCLC patients were treated with nivolumab (3 mg/kg) every two weeks. Blood samples were collected just before the infusion on days 0 (baseline), 14, 28 and 42 after treatment start. Plasma trough levels (Cmin) of nivolumab were assayed with home-made ELISA. Univariate linear regression models were performed in order to explain the inter-patient variability in nivolumab Cmin on day 42. Multivariate model included all variables which were significant at the 10% level in the univariate analyses.


The calibration for nivolumab assay was linear in the range 5-100 µg/mL. Intra- and interday imprecision for three internal quality controls (5, 20 and 75 µg/mL) were less than 9 and 12%, respectively. The median age of the cohort was 68 years (range 41-84) and the sex ratio (female/male) 1.27. The median dose of nivolumab was 207 mg (range 147-288). No nivolumab was detected in baseline samples. The mean nivolumab Cmin was 17.3 ± 4.8 µg/mL (CV = 27.8%), 25.0 ± 9.7 µg/mL (CV = 38.8%) and 33.0 ± 12.9 µg/mL (CV = 39.1%) on days 14, 28 and 42, respectively. A significant variation in nivolumab Cmin was observed over the time (one-way Anova test, p 


These preliminary results highlight a large inter-patient variability in nivolumab Cmin in NSCLC outpatients. Further PK/PD investigations are warranted to identify the influence of this pharmacokinetic variability on clinical outcomes.

Clinical trial identification

Not applicable

Legal entity responsible for the study





All authors have declared no conflicts of interest.

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