a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (e7080) in...

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A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT) Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

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Page 1: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT)

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 2: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Disclosures

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 3: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Study Rationale

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 4: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Study 303: Study Schema

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 5: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Patient Characteristics

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 6: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Primary Endpoint:<br />Kaplan-Meier Estimate of PFS

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 7: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

PFS by Previous VEGF-Targeted Therapy

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 8: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

PFS Subgroup Analyses

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 9: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Response Rates

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 10: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Best Tumor Response

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 11: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Overall Survival, ITT population

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 12: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Study Medication Exposure

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 13: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Treatment-emergent Adverse Events (TEAEs)

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 14: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Most Frequent Treatment-related Adverse Events (> 20%)

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 15: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

TEAEs of Special Interest

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 16: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Conclusions

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting

Page 17: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid

Slide 17

Presented By Martin Schlumberger at 2014 ASCO Annual Meeting