Lenvima gives hope to differentiated thyroid cancer patients22 Oct 2015
Cancer patients with metastatic differentiated thyroid cancer who received lenvatinib (Lenvima) had a better prognosis, and this was true across all common sites of metastasis, researchers reported.
Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor with a novel binding mode, which selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors, in addition to other pro-angiogenic and oncogenic pathway-related kinases involved in tumor proliferation. It was approved by the FDA for the treatment of refractory differentiated thyroid cancer earlier this year.
Clinical trial’s details
Mouhammed Habra, MD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues performed a sub-analysis of the phase 3, randomized SELECT trial. In the trial, median PFS was 18.3 months with lenvatinib and 3.6 months with placebo, a 79% reduction in the risk of progression that was highly statistically significant.
The trial enrolled adults with differentiated thyroid cancer who were diagnosed as being radioiodine-refractory, as demonstrated by evidence of progression within the previous 13 months. They also had to have measurable disease and show progression despite treatment with VEGF receptor-targeted therapy. The patients were randomized in a 2-to-1 fashion, with the majority of patients receiving lenvatinib (24 mg orally a day until progression of disease was verified by RECIST criteria). About 90% of the patients had not received any therapy for metastatic thyroid disease.
Habra and colleagues wanted to see if there were subgroups of patients who did particularly well -- or particularly poorly -- based on the site of the metastases or the number of metastatic sites.
Study findings proving a treatment benefit with lenvatinib
According to study author, clinical findings suggest a treatment benefit versus placebo with lenvatinib regardless of number and type of metastatic sites at baseline. In particular:
- In patients with lung metastasis, the median progression-free survival (PFS) was 18.7 months with lenvatinib versus a median PFS of 3.6 months with placebo, according to Mouhammed Habra, MD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues.
- Also, median PFS for patients with liver metastases was 7.6 months with lenvatinib versus 3.7 months with placebo.
- In those patients with bone metastases, median PFS was 14.8 months versus 2.1 months with placebo.
- In addition, overall response rates were 66.7% for patients with brain metastases, 51% for those with bone metastases, 51.2% for those with liver metastases, 68.1% for those with lung metastases, and 65.2 for those with lymph node metastases. While metastases to the brain also responded to lenvatinib, only 16 patients had those lesions so a significant difference could not be shown, Habra said.
“Very compelling results”
According to the SELECT trial results, nearly all of the patients (97%) in the study arm experienced some adverse events, most often hypertension, diarrhea, fatigue, and decreased appetite. Twenty people in the lenvatinib group died compared with five patients on placebo, and six of those 20 were considered to be treatment-related.
"These results are very compelling," said Eylem Cagiltay, MD, an endocrinology specialist in Izmir, Turkey. "I will be seeking to use this medicine in my patients," he added.Source: MedPage Today