Eisai and MSD’s Lenvima (lenvatinib) has been approved in the US for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

The decision was based on results of the REFLECT trial, in which Lenvima (lenvatinib) showed non-inferiority to Bayer’s Nexavar (sorafenib) on overall survival, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR).

Patients treated with Lenvima experienced a median OS of 13.6 months compared to 12.3 months with sorafenib, while median PFS was 7.3 months versus 3.6 months, respectively.

"Unresectable hepatocellular carcinoma is an extremely difficult-to-treat cancer, with no new first-line systemic therapy options for more than a decade," said Dr Ghassan Abou-Alfa, medical oncologist, Memorial Sloan Kettering Cancer Center.

"REFLECT is the first-ever positive Phase III trial against an active comparator in unresectable HCC. The efficacy and safety data from REFLECT are important findings for oncologists and others in the multidisciplinary teams who treat liver cancer, as well as for our patients who are affected by it."

On the safety side, the most common adverse reactions (≥20 percent) observed in patients treated with Lenvima were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism and nausea. Those for sorafenib were palmar-plantar erythrodysesthesia syndrome, diarrhea, fatigue, hypertension, abdominal pain, decreased appetite, rash, decreased weight and arthralgia/myalgia.

The most common serious adverse reactions (≥2 percent) observed in the Lenvima arm were hepatic encephalopathy (5 percent), hepatic failure (3 percent), ascites (3 percent) and decreased appetite (2 percent), while those reported in the comparator group were ascites (2 percent) and abdominal pain (2 percent).

Lenvima was first approved in the US in 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC), and in 2016 in combination with everolimus for patients with advanced renal cell carcinoma (RCC).