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Tyrosine Kinase Inhibitor Lenvatinib Shows Promise in Melanoma Patients
Lenvatinib/dacarbazine combo more effective than dacarbazine alone in phase II trial (June 10)
The results from a phase II proof-of-concept study indicate that lenvatinib (Eisai Company), an investigational vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI), may have therapeutic effects in melanoma patients.
The randomized open-label study compared lenvatinib plus dacarbazine (one of the standard first-line treatment agents in patients with melanoma) with dacarbazine alone in patients with stage IV chemotherapy-naïve melanoma. The study cohort included patients with BRAF wild-type disease.
The results demonstrated a statistically significant 2.7-fold increase in progression-free survival (PFS) in patients treated with the combination of lenvatinib and dacarbazine versus dacarbazine alone (median PFS: 19.1 weeks vs. 7.0 weeks, respectively; P = 0.0033). In addition, a statistically significant 3.9-fold increase in PFS was observed in a subgroup of patients with BRAF wild-type melanoma treated with the combination of lenvatinib and dacarbazine versus dacarbazine alone (median PFS: 23.9 weeks vs. 6.1 weeks, respectively; P = 0.0306).
Preparations are under way for further studies of lenvatinib in melanoma, with the aim of gaining regulatory approval.
Source: Eisai; June 10, 2013.