G-BA confirms additional benefit of Eisai’s Kisplyx to treat advanced RCC
The German Federal Joint Committee (G-BA) has confirmed the additional benefit of Eisai’s in-house developed anti-cancer agent, Kisplyx (lenvatinib mesylate), to treat advanced renal-cell carcinoma (RCC).
Based on the benefit assessment for insurance reimbursement, the company plans to carry out price negotiations with the Head Association of German Sick Funds (GKV-SV) and agree to a reimbursement price.
Lenvatinib is an orally administered, multiple receptor tyrosine kinase (RTK) inhibitor.
The assessment was based on a Phase II clinical study (Study 205) that evaluated the safety and efficacy of Kisplyx in combination with everolimus in patients with unresectable advanced or metastatic RCC.
As part of the multicentre, randomised, open-label study, 153 patients were randomised in a 1:1:1 ratio to one of three treatment arms to compare the efficacy and safety of these regimens.
From the results, the Kisplyx plus everolimus group demonstrated an extension in the study's primary endpoint of progression free survival (PFS) and also in median overall survival (OS).
The most common treatment-emergent adverse events (TEAEs) reported in the Kisplyx plus everolimus group were diarrhoea, decreased appetite and fatigue.
For Grade 3 or higher the TEAEs reported were diarrhoea, hypertension and fatigue.
RCC consists of more than 90% of all malignancies of the kidney and originates from malignant cells in the lining of the kidney's tubules.
In people older than 55, the incidence of RCC is increasing and is expected to affect men rather than women.
Lenvatinib mesylate has been designated as an orphan drug for thyroid cancer in Europe.
Eisai has currently obtained approval for the agent as a treatment for refractory thyroid cancer in more than 50 countries, including the US, Japan, Europe, Korea, Mexico, and Brazil.
Lenvatinib was also approved in the US in May last year, for an additional indication in combination with everolimus to treat patients with advanced RCC following one prior anti-angiogenic therapy.
Image: High magnification micrograph of a clear-cell renal-cell carcinoma. Photo: courtesy of Nephron.