Lenvatinib FDA approved for 1st-line treatment of HCC

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Lenvatinib FDA approved for 1^st-line treatment of HCC

By: News Feed | Last updated: 18th August 2018 | In: Gastrointestinal Cancer, Oncology, Targeted Therapies, US FDA Onc\Haem Approvals

Article Keywords

Bayer, Eisai, FDA, HCC, lenvatinib, Lenvima, Liver, sorafenib

On August 16, 2018 the FDA approved lenvatinib (Lenvima®, Eisai) for the first-line treatment of hepatocellular carcinoma (HCC) patients not amenable for curative surgery.

REFLECT

The multicenter, open-label, non-inferiority REFLECT trial (NCT01761266) randomised 954 metastatic or unresectable and systemic treatment-naïve HCC patients 1:1 to either receive lenvatinib or sorafenib until radiological disease progression or unacceptable toxicity.

Lenvatinib was non-inferior to sorafenib on the primary endpoint of overall survival (OS). The median OS was 13.6 months with lenvatinib vs 12.3 months with sorafenib (HR=0.92; 95% CI, 0.79-1.06). The secondary endpoint progression-free survival (PFS) was improved in patients treated with lenvatinib; median PFS with lenvatinib was 7.3 months compared to 3.6 months with sorafenib (HR=0.64; 95% CI, 0.55-0.75; p<0.001) by modified RECIST (mRECIST) and consistent when using RECIST 1.1. Lenvatinib was associated with a higher overall response rate (ORR) as compared to sorafenib, 41% vs. 12% by mRECIST and 19% vs. 7% by RECIST 1.1, both respectively.

SAFETY

Adverse reactions in observed in ≥20% of lenvatinib-treated HCC patients were hypertension, fatigue, diarrhoea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, haemorrhagic events, hypothyroidism, and nausea.

Lenvima® full prescribing information

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

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Trackbacks & Pingbacks

ESMO 2018 HCC: The ESMO18 hepatobiliary cancer track summarised says:

5th November 2018 at 12:48 PM

[…] the Phase III, open-label, randomised REFCLECT (NCT01761266) study showed non-inferiority for levantinib -a multikinase inhibitor of VEGFR 1–3, […]

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