Eisai and MSD’s Lenvima has won approval in the EU as a first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

The decision, which gives patients in Europe the first new first-line treatment option for the condition in more than 10 years, closely follows a green light in the US earlier this month.

On both sides of the Atlantic, approval was based on data from 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.

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).

“Patients with hepatocellular carcinoma are faced with a cancer that is difficult to treat and has a particularly poor prognosis, with only one systemic first-line treatment option currently available,” said Gary Hendler, chairman and chief executive of Eisai EMEA.

“Lenvatinib is the first new treatment option to be made available in this first-line systemic treatment setting in over a decade and represents an important new therapeutic option for patients. Eisai and Merck are therefore committed to working together to ensure that patients have rapid access to lenvatinib across Europe.”

Earlier this year Eisai and MSD entered into a strategic collaboration for the worldwide co-development and co-commercialisation of Lenvima (lenvatinib), both as monotherapy and in combination with anti-PD-1 therapy Keytruda (pembrolizumab).