The only category 1 National Comprehensive Cancer Network® (NCCN®)-preferred first-line systemic therapy option
Lenvatinib (LENVIMA) is the only category 1 preferred first-line systemic therapy option by the NCCN for locally recurrent or metastatic, progressive radioactive iodine-refractory differentiated thyroid cancer*
#1 prescribed 1L therapy for certain patients with RAI-R DTC1‡
NCCN=National Comprehensive Cancer Network® (NCCN®).
RAI-R=radioactive iodine-refractory; DTC=differentiated thyroid cancer.
*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Thyroid Carcinoma V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed November 1, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
†Category 1 recommendation is based on high-level evidence. There is uniform NCCN consensus that the intervention is appropriate.
‡Ipsos Healthcare US Oncology Monitor (June 2021-May 2022, 281 physicians reporting on 1,564 patients with stage 4 RAI-R DTC, all data collected online) © Ipsos 2022, all rights reserved.1
See the efficacy of LENVIMA
PRIMARY ENDPOINT
Superior PFS benefit
Median PFS: 18.3 months with LENVIMA vs 3.6 months with placebo2
- 18.3 months median PFS: (95% CI: 15.1-NE) with LENVIMA vs 3.6 months (95% CI: 2.2-3.7) with placebo (HR: 0.21 [95% CI: 0.16-0.28]; P<0.001)
SELECT study results based on a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with locally recurrent or metastatic RAI-R DTC (N=392) who have had radiographic evidence of disease progression within 12 months prior to randomization as confirmed by independent radiologic review. The primary endpoint was PFS as determined by blinded independent radiologic review using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Secondary endpoints included objective response rate and overall survival.2,3
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107 events (41%) occurred in the LENVIMA arm vs 113 events (86%) in the placebo arm2
- 93 patients (36%) who received LENVIMA progressed vs 109 patients (83%) who received placebo
- Death occurred in 14 patients (5%) who received LENVIMA vs 4 patients (3%) who received placebo
SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid; PFS=progression-free survival; OS=overall survival; NE=not estimable; HR=hazard ratio; RAI-R=radioactive iodine-refractory; DTC=differentiated thyroid cancer.
SECONDARY ENDPOINT
Superior response
65% ORRa with LENVIMA vs 2% ORR with placebo2,3
- 65% ORR: (95% CI: 59%-71%) vs 2% ORR (95% CI: 0%-4%) with placebo (no CR)
FIRST TKI TO DEMONSTRATE A COMPLETE RESPONSE IN A PHASE 3 TRIAL FOR LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE RAI-R DTC2-4
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Median OS was not estimable at data cutoff (HR: 0.73 [95% Cl: 0.50-1.07]; P=0.10)2
- 83% (109/131) of placebo-treated patients with confirmed disease progression crossed over to receive LENVIMA in the open-label extension phase (data cutoff: November 15, 2013)2,3
TKl=tyrosine kinase inhibitor; RAI-R=radioactive iodine-refractory; DTC=differentiated thyroid cancer; OS=overall survival; HR=hazard ratio; RECIST=Response Evaluation Criteria In Solid Tumors.
Responses evaluated using RECIST 1.1.2,3
- aObjective response rate (ORR)=sum of CR and PR.2,5
- bPartial response (PR)=30% or greater decrease in the sum of diameters of target lesions.5
- cComplete response (CR)=disappearance of all target and nontarget lesions.5
- dAccording to the Cochran-Mantel-Haenszel chi-square test.2