Lenvatinib: Phase Ib/II data

Data from 78 evaluable patients with stage IV melanoma in the modified intent-to-treat (mITT) population of the Phase II portion of a Phase Ib/II trial showed that 20 mg oral lenvatinib plus dacarbazine met the primary endpoint of improving median PFS vs. dacarbazine alone (19.1 vs. 7 weeks, p=0.0033). In patients with wild-type BRAF V600 (n=37), lenvatinib plus dacarbazine led to a median PFS of 23.9 weeks vs. 9.3 weeks for dacarbazine alone. In patients with BRAF V600 mutations (n=9), lenvatinib plus dacarbazine led to a median PFS of 6.3 weeks vs. 6 weeks for dacarbazine alone. The most common adverse events reported in the lenvatinib arm were hypertension, nausea, constipation and diarrhea. The most common grade 3/4 adverse events reported were hypertension and neutropenia. Patients received once-daily 16, 20 or 24 mg oral lenvatinib in the Phase Ib portion, which resulted in an MTD of 20 mg. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...