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Bending the Curve Trial by Trial
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SELECT

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer

Phase 3N = 392NCT01321554

Population
Progressive thyroid cancer refractory to iodine-131 (radioiodine-refractory differentiated thyroid cancer)
Design
Multicentre, randomised, double-blind, placebo-controlled phase 3 trial of lenvatinib 24 mg daily in 28-day cycles versus placebo. Primary end point progression-free survival; secondary end points included response rate, overall survival and safety. At progression, placebo patients could receive open-label lenvatinib.
Primary endpoint
PFS
Arms
  • Lenvatinib (experimental, n = 261): Lenvatinib 24 mg orally once daily in 28-day cycles
  • Placebo (control, n = 131): Matching placebo
People
Schlumberger M
PFSHR 0.21Δ median PFS+14.7 monthsΔ ORR+63.3 points
Show the numbers
Results reported for SELECT
EndpointAnalysisLenvatinibPlaceboEffect
PFSRandomised patients (261 lenvatinib, 131 placebo); the abstract does not name the analysis populationprimarySchlumberger 2015median 18.3 monthsmedian 3.6 monthsHR 0.21P<0.001The abstract gives a 99% confidence interval for the hazard ratio of 0.14 to 0.31 (hazard ratio for progression or death); it is not recorded as a 95% interval. Progression-free survival benefit with lenvatinib was seen in all prespecified subgroups (abstract).
ORRRandomised patients (261 lenvatinib, 131 placebo); the abstract does not name the analysis populationprimarySchlumberger 201564.8%1.5%P<0.001Response rate was a secondary end point. The abstract reports 4 complete responses and 165 partial responses in the lenvatinib group. Median overall survival was not reached in either group.
Results reported for SELECT
EndpointAnalysisLenvatinibPlaceboEffect
PFSRandomised patients (261 lenvatinib, 131 placebo); the abstract does not name the analysis populationprimarySchlumberger 2015median 18.3 monthsmedian 3.6 monthsHR 0.21P<0.001The abstract gives a 99% confidence interval for the hazard ratio of 0.14 to 0.31 (hazard ratio for progression or death); it is not recorded as a 95% interval. Progression-free survival benefit with lenvatinib was seen in all prespecified subgroups (abstract).
ORRRandomised patients (261 lenvatinib, 131 placebo); the abstract does not name the analysis populationprimarySchlumberger 201564.8%1.5%P<0.001Response rate was a secondary end point. The abstract reports 4 complete responses and 165 partial responses in the lenvatinib group. Median overall survival was not reached in either group.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Lenvatinib (experimental)
  • Placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsLenvatinibPlacebo
0100.0%100.0%
1165.9%12.0%
2341.8%1.2%
3427.6%0.1%
4617.5%0.0%
Primary publication: Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015;372(7):621-30. PubMedDOI

Appears in

Sources

  1. Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015;372(7):621-30.

    PubMedDOI