The approval was supported by findings from the multicenter, randomized, open-label, noninferiority trial, REFLECT (N=945), which included patients with previously untreated, metastatic or unresectable HCC. Study patients received Lenvima based on actual body weight or sorafenib until radiological disease progression or unacceptable toxicity.
Lenvima proved noninferior but not statistically superior to sorafenib for overall survival (hazard ratio [HR] 0.92, 95% CI, 0.79, 1.06). In the Lenvima arm, median overall survival was 13.6 months compared with 12.3 months in the sorafenib arm. Also, a statistically significant improvement in progression-free survival (PFS) was seen with Lenvima vs sorafenib (7.3 months vs 3.6 months; HR 0.64, 95% CI, 0.55, 0.75; P <.001) according to modified Response Evaluation Criteria in Solid Tumors (RECIST) for HCC. Moreover, the objective response rate was greater in the Lenvima arm compared with sorafenib (41% vs 12% per mRECIST; 19% vs 7% per RECIST 1.1).
Lenvima, a kinase inhibitor, is already indicated in combination with everolimus to treat advanced renal cell carcinoma, following one prior anti-angiogenic therapy; and to treat locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.
It is supplied as 4mg and 10mg strength capsules.
For more information call (877) 873-4724 or visit Lenvima.com.