Pivotal data on Lenvima as first-line liver cancer drug

At the annual meeting of the American Society of Clinical Oncology, Japanese pharma major Eisai (TYO: 4523) has released data from a Phase III study into Lenvima (lenvatinib) as a first-line liver cancer therapy.

The data show that lenvatinib is non-inferior to sorafenib, the current standard of care, in median overall survival (OS) for the first-line systemic treatment of patients with unresectable hepatocellular carcinoma (uHCC).

Marketed by German pharma group Bayer (BAYN: DE) as Nexavar, sorafenib was first approved by the US Food and Drug Administration in 2005.

The median OS for patients treated with Lenvima was 13.6 months, compared to 12.3 months for Nexavar.

The company says the trial has also shown improvements in the secondary endpoints of progression-free survival, time to progression and objective response rate.

"Results from this large Phase III trial demonstrate the potential of lenvatinib to improve the outcomes of liver cancer patients, and provide an overall survival benefit that is non-inferior to sorafenib, currently the only systemic therapy approved by the European Medicines Agency for unresectable HCC," said study investigator Jeff Evans of the University of Glasgow.

"For a decade there has been no advance in the first-line systemic treatment of uHCC in Europe, so this data supports a potential new option for liver cancer patients that offers greater choice."

Gary Hendler, chief commercial officer for the company’s oncology business, said: "Based on these data, Eisai plans to submit regulatory applications for lenvatinib for the first-line treatment of patients with unresectable HCC and we look forward to working closely with the European Medicines Agency and other regulatory bodies worldwide."

Hepatocellular carcinoma is a complex disease associated with a poor prognosis and accounts for approximately 90% of liver cancer cases worldwide.

In Europe an estimated 71,000 people were diagnosed with liver cancer and 69,000 people died from this disease in 2012.