Lenvima non-inferior to Nexavar in treating unresectable HCC

CHICAGO — Results of a phase 3 trial showed that Lenvima was non-inferior to Nexavar in median overall survival for patients with unresectable hepatocellular carcinoma, according to a presentation at the ASCO Annual Meeting.

“Results from this large phase 3 trial demonstrate the potential of [Lenvima] to improve the outcomes of liver cancer patients, and provide an overall survival benefit that is non-inferior to [Nexavar], currently the only systemic therapy approved by the European Medicines Agency for unresectable HCC,” Jeff Evans, MD, FRCP, from the University of Glasgow, said in a press release. “For a decade, there has been no advance in the first-line systemic treatment of [unresectable] HCC in Europe, so this data supports a potential new option for liver cancer patients that offers greater choice.”

The REFLECT study consisted of two treatment arms: 478 patients who received Lenvima (lenvatinib, Eisai) and 476 patients who received Nexavar (sorafenib, Onyx Pharmaceuticals). Median overall survival for patients receiving lenvatinib was 13.6 months (95% CI, 12.1-14.9) compared with 12.3 months (95% CI, 10.4-13.9) in the Nexevar group (HR = 0.92; 95% CI, 0.79-1.06).

Results of the study’s secondary endpoints showed that lenvatinib has a median progression-free survival time of 7.4 months (95% CI, 6.9-8.8) compared with 3.7 months (95% CI, 3.6-4.6) in the sorafenib group (HR = 0.66; 95% CI, 0.57-0.77) and median time to progression in the lenvatinib group was 8.9 months (95% CI, 7.4-9.2) compared with 3.7 months (95% CI, 3.6-5.4) with sorafenib (HR = 0.63; 95% CI, 0.53-0.73). Additionally, lenvatinib had an objective response rate of 24% compared with 9% in the sorafenib group (OR = 3.13; 95% CI, 2.15-4.56).

“Eisai is excited by the potential of the results seen with lenvatinib in Study 304 to provide improved outcomes for patients with unresectable HCC, who face a poor prognosis and are in need of additional treatment options,” Gary Hendler, chairman, CEO of the Europe, Middle East and Asia region and chief commercial officer of the Oncology Business Group at Eisai, said in the release. “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.”

Reference: Cheng A, et al. Abstract 4001. Presented at: ASCO Annual Meeting; June 2-6, 2017; Chicago.

Disclosure: Cheng reports receiving consulting or advisory fees from Bayer Schering Pharma, Bristol-Myers Squibb, Merck Serono, Novartis and ONXEO; research funding from Sanofi; and is on the speakers bureau for Novartis.