A NICE technology appraisal (TA) has recommended lenvatinib (Lenvima) and sorafenib (Nexavar) as treatment options for progressive, locally advanced or metastatic differentiated thyroid cancer that is refractory to radioactive iodine. The products are to be used only in patients who are naive to tyrosine kinase inhibitors (TKIs) or have discontinued TKI treatment within three months of initiation due to unmanageable toxicity.
The recommendation does not include people having lenvatinib after disease progression on sorafenib which is currently provided through compassionate use.
The decision is based on data from the phase 3 SELECT trial of lenvatinib and the DECISION trial of sorafenib.
In SELECT, lenvatinib improved median investigator-assessed progression-free survival (PFS) vs placebo (16.6 mo vs 3.7 mo; hazard ratio [HR] 0.24; 95% CI 0.16-0.35). In DECISION, sorafenib achieved median investigator-assessed PFS or 10.8 mo vs 5.4 mo with placebo (HR 0.49; 95% CI 0.39-0.61).
After correcting for crossover, there was a statistically significant overall survival (OS) benefit for lenvatinib (adjusted HR 0.54; 95% CI 0.36-0.80) but not for sorafenib.
In patients previously treated with a TKI, median PFS was 15.1 mo with lenvatinib vs 3.6 mo for placebo (HR 0.22; 95% CI 0.12-0.41). Objective tumor response rate was 62.1% vs 3.7% for placebo.
The TA guidance states that, based on commercial agreements with the pharmaceutical companies, the incremental cost-effectiveness ratio (ICER) for both treatments was more than £30,000 per quality-adjusted life year (QALY) gained.
