Wirth Discusses SELECT Trial: Lenvatinib in RAI-Refractory DTC
Lori J. Wirth, MD, discusses the background and design of the phase 3 SELECT trial of lenvatinib vs placebo for the treatment of patients with radioactive iodine-refractory differentiated thyroid cancer.
Lori J. Wirth, MD, associate professor of medicine at Harvard Medical School and medical director of the Center for Head and Neck Cancers at Massachusetts General Hospital, discusses the background and design of the phase 3 SELECT trial (NCT01321554) of lenvatinib (Lenvima) vs placebo for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC).
SELECT was a randomized, placebo-controlled phase 3 trial which evaluated progression-free survival among patients with RAI-refractory DTC treated with lenvatinib vs placebo. Patients enrolled were treated with once-daily oral lenvatinib (24 mg) vs placebo. Secondary end points of the study included overall response rate, overall survival, and safety.
The results of this trial serve as the basis for the FDA approval of lenvatinib as the agent showed a PFS advantage along with good responses. The median PFS was 18.3 months with lenvatinib compared with 3.6 months with placebo (HR, 0.21; 99% CI, 0.14-0.31; P <.001).
Transcription:
0:09 | The SELECT trial was a randomized, phase 3 trial investigating lenvatinib compared to placebo in patients with progressive radioiodine-refractory differentiated thyroid cancer. Thyroid cancer can be relatively indolent, so patients were required to have disease progression within the first within 14 months prior to entering the trial in order to be eligible. There was a 2:1 randomization to lenvatinib vs placebo, and then crossover was incorporated into this study design, so it was blinded, of course, and then when patients were found to have disease progression that was centrally confirmed, they were unblinded, and those that were on the placebo arm then were offered crossover to the lenvatinib active drug.
1:06 | The primary end point of the trial was progression-free survival, and the typical secondary end points investigated as well [were] response rate, overall survival, [adverse] effect profile, and so forth.
1:21 | SELECT did lead to the approval of lenvatinib by healthcare authorities around the world for the treatment of patients with iodine-refractory, progressive, differentiated thyroid cancer, and that was based on a very significant progression-free survival benefit with lenvatinib compared to placebo. There was an improvement of 14 months in PFS from the placebo arm to the lenvatinib arm. In the patients randomized to placebo, their median PFS was 3.6 months, whereas in the patients randomized to the lenvatinib arm, their median PFS was over 18 months. That was a big progression-free survival benefit.
2:02 | We also saw good objective response rates in patients treated with lenvatinib. The objective response rate that was centrally confirmed was 65%, so we see high responses. In the patients who did not meet the criteria for response, most of those patients did have stable disease as their best response. There were very few patients who had disease progression as their best response when they were on lenvatinib in SELECT.
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