962P - Responses in specific metastases following treatment with lenvatinib (LN): Results from the phase 3 SELECT trial

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Head and Neck Cancers
Presenter Bruce Robinson
Citation Annals of Oncology (2016) 27 (6): 328-350. 10.1093/annonc/mdw376
Authors B. Robinson1, M. Schlumberger2, L.J. Wirth3, C.E. Dutcus4, T.A. Binder4, M. Guo4, M. Taylor5, S.B. Kim6, M.K. Krzyzanowska7, J. Capdevilla8, S.I. Sherman9, M. Tahara10
  • 1Kolling Institute Of Medical Research, University of Sydney, 2006 - St Leonards/AU
  • 2Department Of Nuclear Medicine And Endocrine Oncology, Gustave Roussy and University Paris-Sud, Villejuif/FR
  • 3Department Of Medicine, Massachusetts General Hospital, Boston/US
  • 4Eisai, Inc., 07677 - Woodcliff Lake/US
  • 5Knight Cancer Institute, Oregon Health Science University, 97239 - Portland/US
  • 6Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 7Division Of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto/CA
  • 8Medical Oncology Department Vall D’hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona/ES
  • 9Department Of Endocrine Neoplasia And Hormonal Disorders, Division Of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston/US
  • 10Department Of Head And Neck Medical Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP

Abstract

Background

LN is an oral, multikinase inhibitor that significantly prolonged median progression-free survival vs placebo (PB) in a phase 3 study of patients (pts) with radioiodine-refractory differentiated thyroid cancer (RR-DTC; 18.3 vs 3.6 months; hazard ratio [HR] 0.21; 99% confidence interval [CI] 0.14–0.31; P 

Methods

Pts with RR-DTC in this double-blind, multicenter study were randomized 2:1 to LN or PB (24mg/d; 28-d cycle). Tumor assessments in specific metastasis sites were evaluated by independent radiologic review using the Response Evaluation Criteria in Solid Tumors v1.1 at baseline and 8-week intervals. Sites evaluated were lung, liver, lymph nodes, and bone.

Results

Following LN treatment, pts showed tumor shrinkage in all targeted sites compared with baseline (Table 1). The mean maximum change in sum of target lesions (in mm; see table) from baseline was significantly greater in pts treated with LN vs PB in the lungs (–15.1 vs 1.4), liver (–17.7 vs 2.5), lymph nodes (–17.4 vs –0.8), and bone (–6.7 vs 3.4). In pts treated with LN vs PB, a greater percent change from baseline (%) was observed in the lung (–45.9 vs 2.7), liver (–35.6 vs 5.1), lymph nodes (–47.5 vs 2.9), and bone (–10.7 vs 6.5). In the LN arm, median duration of objective response was not estimable (NE; 95% CI 16.6─NE; n = 139), 7.3 (1.9─NE; n = 7), 16.8 (95% CI 12.9─NE; n = 84), and 12.9 (95% CI 3.6─NE; n = 10) months for pts with lung, liver, lymph node, and bone metastases, respectively.

Conclusions

In targeted metastasis sites, greater tumor shrinkage was observed following LN treatment vs PB. These data provide additional evidence of the clinical benefit of LN in the treatment of RR-DTC, particularly in pts with specific metastases, although responses are also seen in bone metastases.

Lung Liver Lymph node Bone
PB LN PB LN PB LN PB LN
Baseline
n 107 199 12 15 57 126 17 41
Mean, mm 36.5 35.0 54.9 47.6 39.8 37.5 63.1 65.9
Maximum change
n 103 189 12 14 55 119 16 34
Mean, mm 1.4 -15.1 2.5 -17.7* -0.8 -17.4 3.4 -6.7*
Mean, % 2.7 -45.9 5.1 -35.6 -2.9 -47.5 6.5 -10.7*

* P

Clinical trial identification

NCT01321554

Legal entity responsible for the study

Eisai Inc.,

Funding

Eisai Inc.,

Disclosure

B. Robinson: Advisory Board member for Eisai, Astra Zeneca, Bayer and has served as a board member for MaynePharma. M. Schlumberger: Received grants and personal fees from Eisai Inc. L.J. Wirth: Served as an advisory board member for Eisai and Loxo and has consulted for Eisai and Ashion. C.E. Dutcus: Employee of Eisai Inc. T.A. Binder, M. Guo: Employee of Eisai Inc. M. Taylor: Served as an advisory board consultant for Eisai and ONYX. M.K. Krzyzanowska: Served as an advisory board member for Eisai and Bayer, and has received research funding (site PI for clinical trials) for Eisai, Astra Zeneca, Exelixis, and Novartis. J. Capdevilla: Served as an advisory board member for Eisai, Bayer, Astra Zeneca, and received research funding for Eisai, Bayer, and Astra Zeneca. S.I. Sherman: Served as an advisory board member for Eisai and Veracyte, has consulted for Exelixis and Rosetta Genomics, and has received research funding from Genzyme. M. Tahara: Received grants, research support, and honoraria from Eisai Inc.; received grants and personal fees from Merck Sharpe & Dohme; and received personal fees from Merck Serono, Bristol Myer Squibb, Otsuka, and Bayer. All other authors have declared no conflicts of interest.