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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

4679 - Correlative analyses of serum biomarkers and efficacy outcomes in the randomized phase 2 trial of lenvatinib (LEN), everolimus (EVE), or LEN+EVE in patients with metastatic renal cell carcinoma


20 Oct 2018


Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research


Translational Research

Tumour Site

Renal Cell Cancer


Chung-Han Lee


Annals of Oncology (2018) 29 (suppl_8): viii14-viii57. 10.1093/annonc/mdy269


C. Lee1, R.J. Motzer1, H. Glen2, M.D. Michaelson3, J. Larkin4, Y. Minoshima5, M. Kanekiyo5, R. Dairiki5, P. Sachdev6, C.E. Dutcus6, Y. Funahashi5, M.H. Voss1

Author affiliations

  • 1 Department Of Medicine, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 2 Medical Oncology, Beatson West of Scotland Cancer Centre, G12 0YN - Glasgow/GB
  • 3 Hematology/oncology, Massachusetts General Hospital, 2114 - Boston/US
  • 4 Department Of Medical Oncology, Royal Marsden NHS Hospital, London/GB
  • 5 Eisai Co., Ltd., Ibaraki/JP
  • 6 Oncology Business Group, Eisai Inc., NJ 07677 - Woodcliff Lake/US


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Abstract 4679


In a randomized, 3-arm, phase 2 trial of patients (pts) with metastatic renal cell carcinoma (mRCC) following 1 VEGF-targeted therapy, LEN+EVE improved median progression-free survival (PFS) compared with EVE (hazard ratio [HR] 0.40; 95% confidence interval [CI] 0.24–0.68; P < 0.001) or LEN (HR 0.66; 95% CI 0.39–1.10; P = 0.121).(Motzer et al. Lancet Oncol 2015) We present biomarker analyses from this study.


Serum samples collected at baseline were analyzed by Luminex-based xMAP® assays for 40 candidate biomarkers. Baseline biomarker levels were correlated with PFS using Cox regression analysis. Biomarkers with the strongest associations (top 5 ranked by log-rank P-value and HR) with PFS in the LEN+EVE arm were integrated into composite biomarker scores (CBS)(Voss et al. Br J Cancer 2016) All P-values are nominal.


Serum samples from 145 pts (LEN+EVE, n = 49; LEN, n = 50; EVE, n = 46) were analyzed. HGF, MIG, IL-18BP, IL-18, and ANG-2 concentrations demonstrated the strongest correlation with PFS and were selected for the CBS analysis. Associations with PFS are summarized in the table. In the LEN+EVE arm, median PFS for pts with high (3–5) vs low (0–2) CBS was 20.1 vs 5.6 months, respectively (HR 0.28; P = 0.002), whereas no significant difference between high vs low CBS was seen in the EVE arm (3.6 vs 5.5 months; HR 1.02; P = 0.951). Median PFS differed significantly between treatment arms for pts with high CBS (LEN+EVE vs EVE, 20.1 vs 3.6 months; P < 0.001), but not for pts with low CBS (LEN+EVE vs EVE, 5.6 vs 5.5 months; P = 0.329).Table: 76P

nMedian PFS (months)nMedian PFS (months)
Total5114.6505.50.40 (CI 0.24–0.68) P < 0.001
High CBS2820.1203.60.19 (0.09–0.41) P < 0.001
Low CBS205.6245.50.70 (0.34–1.43) P = 0.329
High vs low HR (95% CI)0.28 (0.12–0.63) P = 0.0021.02 (0.52–1.99) P = 0.951


In pts treated with LEN+EVE, high CBS was correlated with PFS benefit; further research is needed to determine if the score can be used to identify pts who may benefit from combination therapy. Altogether, these biomarkers may be predictors of response to LEN+EVE therapy in pts with mRCC.

Clinical trial identification


Legal entity responsible for the study

Eisai Inc.


Eisai Inc.

Editorial Acknowledgement

Editorial assistance was provided by Oxford PharmaGenesis of Newtown, PA, USA, which was funded by Eisai Inc.


C-H. Lee: Consulting/advisory role: Exelixis; Research funding: Bristol-Myers Squibb, Eisai, Pfizer. R.J. Motzer: Consulting/advisory role: Eisai, Exelixis, Novartis, Pfizer; Research funding: Bristol-Myers Squibb, Eisai, Genentech/Roche, GlaxoSmithKline, Novartis, Pfizer; Travel, accomodations, expenses: Bristol-Myers Squibb. H. Glen: Consulting/advisory role: Astellas Pharma, Eisai, and Janssen; Research funding: Eisai. M.D. Michaelson: Consulting/advisory role: Exelixis, Novartis, Pfizer; Research funding: Argos Therapeutics, Bristol-Myers Squibb, Eisai, Exelixis, Genentech, Merck, Pfizer, Takeda. J. Larkin: Research funding: Pfizer (institution), Novartis (institution), Bristol-Myers Squibb, Merck Sharp & Dohme; Travel, accomodations, expenses: Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Novartis, GlaxoSmithKline, Genentech, Eisai. Y. Minoshima, M. Kanekiyo, R. Dairiki, Y. Funahashi: Employee: Eisai Co., Ltd. P. Sachdev, C.E. Dutcus: Employee: Eisai Inc. M.H. Voss: Honoraria: Novartis; Consulting/advisory role: Alexion Pharmaceuticals, Calithera Biosciences, Exelixis, GlaxoSmithKline, Natera, Novartis, Pfizer; Research funding: Bristol-Myers Squibb, Genentech/Roche, Pfizer; Travel, accommodations, expenses: Novartis, Takeda.

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