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Promising Benefit Seen with Anlotinib in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma

Findings of the Chinese phase II study with novel, orally administered tyrosine kinase inhibitor
21 Nov 2020
Anticancer agents & Biologic therapy;  Endocrine and neuroendocrine tumours

Patients with locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma (RAIR-DTC) demonstrated a statistically significant progression-free survival (PFS) benefit over placebo, as well as higher response rates, according to findings from a phase II study presented at the ESMO Asia Virtual Congress 2020, held from 20 to 22 November 2020.

Yihebali Chi of the Department of Medical Oncology, National Cancer Centre / National Clinical Research Centre for Cancer / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College in Beijing, China described anlotinib as a new, orally administered tyrosine kinase inhibitor (TKI) that targets the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit.

Single-agent anlotinib was granted approval by the China Food and Drug Administration (CFDA) in May 2018 as a third-line treatment for patients with advanced non-small cell lung cancer (NSCLC). 

Professor Chi and colleagues carried out this randomised, double-blind, placebo-controlled, multicentre phase II study (NCT02586337) evaluating anlotinib for the treatment of RAIR-DTC.

The study enrolled patients 18 to 70 years old with measurable, pathologically confirmed locally advanced or metastatic RAIR-DTC who had not received prior treatment with anlotinib or other VEGFR-TKIs.

Following 2:1 randomisation, 76 patients were treated with anlotinib at 12 mg daily for two weeks followed by a week off and 37 patients received placebo. 

The primary endpoint was PFS and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. Patients in the placebo arm were allowed to cross-over to open-label anlotinib upon disease progression.

PFS was significantly prolonged with anlotinib over placebo, thus meeting the primary endpoint

As of data cut-off on 1 January 2020, median PFS was 40.54 months (95% confidence interval [CI] 28.29-not estimated [NE]) with anlotinib compared to 8.38 months (95% CI 5.59-13.80) with placebo (hazard ratio [HR] 0.21 (95% CI 0.12-0.37); p < 0.0001).

Whereas no response was seen in the placebo arm, patients receiving anlotinib demonstrated an ORR of 59.21% (p < 0.0001). Disease control differered significantly between the groups, where patients on anlotinib showed a DCR of 97.37% compared to 78.38% with placebo (p = 0.002).


The study primary and secondary endpoints show encouraging efficacy.

© Yihebali Chi.

The OS data are not yet mature.

All patients receiving anlotinib and 97.30% of patients on placebo experienced adverse events (AEs, p = 0.327), and the incidence of treatment-related AEs was 100.00% versus 86.49%, respectively (p = 0.003). The most commonly reported AEs with anlotinib were hypertension in 84.21%, and hand-foot syndrome in 73.68% of patients. Serious treatment-related AEs occurred in 15.79% of patients receiving anlotinib.


The authors concluded that findings from this study demonstrated the efficacy and safety of anlotinib and support the use of anlotinib as a new option for the treatment of locally advanced or metastatic RAIR-DTC.

This study was funded by the Chia Tai Tian Qing Pharmaceutical Group Co., Ltd.


265O – Chi Y, Gao M, Zhang Y, et al. Anlotinib in locally advanced or metastatic radioiodine-refractory differentiated thyroid carcinoma: a randomized, double-blind, multicenter phase II trial. ESMO Asia Virtual Congress 2020 (20-22 November).

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