Contact a Rep at EISAI ENGAGE

This site is intended for U.S. health
care professionals only.

LENVIMA® (lenvatinib) capsules 10 mg and 4 mg logo
Select an Indication
RAI-refractory DTC 1st-Line treatment of aRCC 2nd-Line treatment of aRCC 1st-Line treatment of uHCC Advanced EC
LENVIMA® for adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer

View SELECT primary and key secondary endpoint data

EXPLORATORY POST HOC ANALYSIS FROM THE SELECT TRIAL

LENVIMA in patients with BRAF mutation+ status

Baseline patient histology in the SELECT trial

182 samples were analyzed for BRAF mutation status1

Baseline characteristics in the intent-to-treat population of the SELECT trial Baseline characteristics in the intent-to-treat population of the SELECT trial

a Histologic findings were determined from investigators' reports.

•The median cumulative RAI activity administered prior to study entry was 350 mCi (12.95 GBq)3

SELECT data cutoff: November 15, 2013.

SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid; DTC=differentiated thyroid cancer; RAI=radioactive iodine; mCI=millicurie; GBq=gigabecquerel.

  • View PFS across certain exploratory subgroups

    Forest plot of hazard ratios for PFS in certain exploratory subgroups2

    SELECT data cutoff: November 15, 2013.

    Forest plot of hazard ratios for progression-free survival in prespecified subgroups Forest plot of hazard ratios for progression-free survival in prespecified subgroups

    Limitations: The SELECT trial was not powered to detect differences in the treatment effect in these subgroups. No statistical testing was planned for this subgroup analysis and no adjustment for multiplicity was made, therefore, no conclusions can be drawn.

    HR=hazard ratio; PFS=progression-free survival; SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid; CI=confidence interval; NE=not estimable.

Exploratory post hoc analysis of papillary thyroid cancer cohort from SELECT (n=122)1

SELECT post hoc exploratory analysis data cutoff: September 1, 2016.

Progression-Free Survival (PFS) by BRAF status1

Progression-free survival of BRAF mutation positive patients and wild type patients for Lenvima (lenvatinib) vs placebo Progression-free survival of BRAF mutation positive patients and wild type patients for Lenvima (lenvatinib) vs placebo

Limitations: Biomarker analyses are exploratory, and results are hypothesis-generating. The post hoc subgroup analysis was not a prespecified study endpoint, and the outcomes cannot be compared across treatment groups. No conclusions can be drawn. Given the sample size, results should be interpreted with caution. Data are descriptive only.

Limitations apply to all data shown below, including real-world PFS, OS, and treatment patterns.

SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid; PFS=progression-free survival; HR=hazard ratio; CI=confidence interval; mPFS=median progression-free survival; NE=not estimable; ORR=objective response rate; OS=overall survival.

Objective Response Rate (ORR) by BRAF status1

•52.0% (95% CI: 31.3%-72.2%; n=13/25) in patients with BRAF mutation+ status vs 64.2% (95% CI: 49.8%-76.9%; n=34/53) in patients with BRAF wild-type status with LENVIMA

•5.3% (95% CI: 0.1%-26.0%; n=1/19) in patients with BRAF mutation+ status vs 4.0% (95% CI: 0.1%-20.4%; n=1/25) in patients with BRAF wild-type status with placebo

SELECT post hoc exploratory analysis data cutoff: September 1, 2016.

CI=confidence interval; SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid.

Overall Survival (OS) by BRAF status1

Overall survival of BRAF mutation positive patients and wild type patients for Lenvima (lenvatinib) vs placebo Overall survival of BRAF mutation positive patients and wild type patients for Lenvima (lenvatinib) vs placebo

SELECT post hoc exploratory analysis data cutoff: September 1, 2016.

HR=hazard ratio; CI=confidence interval; mOS=median overall survival; SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid.

Adverse events by BRAF status4

Adverse events by BRAF status for Lenvima (lenvatinib) vs placebo Adverse events by BRAF status for Lenvima (lenvatinib) vs placebo

SELECT post hoc exploratory analysis data cutoff: September 1, 2016.

TEAEs=treatment-emergent adverse events; SELECT=Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid.

Scroll for
exploratory
analysis
Learn about real-world evidence
Post Hoc Analyses Real-World Evidence