Lenvima(lenvatinib mesylate)

Lenvima (lenvatinib mesylate) is indicated in combination with pembrolizumab for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. Recommended dosages vary by indication: 24 mg orally once daily for Differentiated Thyroid Cancer (DTC); 12 mg orally once daily for Hepatocellular Carcinoma (HCC) for patients >= 60 kg, and 8 mg orally once daily for patients < 60 kg; 20 mg orally once daily in combination with pembrolizumab for EC and Renal Cell Carcinoma (RCC); and 18 mg orally once daily in combination with everolimus for RCC. Lenvima is available in 4 mg and 10 mg capsule strengths.

In the Study E7080-G000-303 (SELECT) trial (N=392, Lenvatinib arm size=261), Lenvatinib demonstrated a median Progression-Free Survival (PFS) of 18.3 months compared to 2.6 months for placebo, with a PFS Hazard Ratio of 0.21 (95% CI: 0.16-0.28, p-value <0.001). The Objective Response Rate for Lenvatinib was 65% versus 2% for placebo (p-value <0.001).

Notable safety findings include hypertension, with an incidence of 73% in SELECT (DTC) and 45% in REFLECT (HCC). Grade 3 hypertension occurred in 44% of patients in SELECT (DTC) and 24% in REFLECT (HCC). The median time to onset of new or worsening hypertension was 16 days in SELECT (DTC) and 26 days in REFLECT (HCC). In Study 205 (RCC) with Lenvima and everolimus, hypertension incidence was 42%, with Grade 3 hypertension in 13% of patients and a median time to onset of 35 days.