The overall survival benefit of lenvatinib is non-inferior to sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC), according to a press release from the developer of lenvatinib, Eisai Inc.1
An ongoing international, open-label, non-inferiority phase 3 trial (ClinicalTrials.gov Identifier: NCT01761266) enrolled 954 patients with unresectable HCC who had not received prior systemic therapy. Participants were randomly assigned 1:1 to receive lenvatinib orally once daily or sorafenib orally twice daily, which is the current standard of care of systemic therapy in this setting, until disease progression or unacceptable toxicity.
In addition to showing non-inferiority between lenvatinib and sorafenib in terms of survival, the study showed clinically meaningful and statistically significant improvements in progression-free survival, time to progression, and objective response rate with lenvatinib.
The safety profile of lenvatinib was consistent with previous reports. The most common adverse events in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss, and fatigue. Further analysis of safety and quality of life are ongoing.
Eisai plans to present the findings of this study in detail at an upcoming medical meeting and discuss these results with the U.S. Food and Drug Administration (FDA).
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Lenvatinib is approved by the FDA for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer, and in combination with everolimus for patients with advanced renal cell carcinoma who have previously received anti-angiogenic therapy.
- Positive topline results of large phase 3 trial show Eisai’s lenvatinib meets primary endpoint in unresectable hepatocellular carcinoma. Eisai website. http://eisai.mediaroom.com/2017-01-25-Positive-Topline-Results-of-Large-Phase-3-Trial-Show-Eisais-Lenvatinib-Meets-Primary-Endpoint-in-Unresectable-Hepatocellular-Carcinoma. Published January 25, 2017. Accessed January 27, 2017.