A phase II trial of lenvatinib, when used in combination with everolimus, showed progression-free survival was significantly extended in patients with metastatic renal cell carcinoma (mRCC) versus everolimus alone. 

The study met its primary endpoint as patients treated with the combination regimen experienced a median progression free survival of 14.6 months compared with 5.5 months for those who received everolimus alone.

The objective response rate in both the lenvatinib plus everolimus group and the lenvatinib alone group demonstrated an improvement compared to the everolimus alone group (lenvatinib plus everolimus: 43% vs everolimus alone: 6%, lenvatinib alone: 27% vs everolimus alone: 6%).

Objective response rate is defined as the proportion of patients to see a tumour size reduction of a predefined amount for a minimum time period. In one of the study’s secondary endpoints of overall survival (OS), an updated analysis carried out in December 2014 confirmed that lenvatinib plus everolimus extends OS, compared to everolimus alone.

For lenvatinib in combination with everolimus, the most common treatment-emergent adverse events (TEAE) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue.

The most common TEAEs of Grade 3 or higher (Common Terminology Criteria for Adverse Events) included diarrhoea, hypertension and fatigue.

Renal cell carcinoma is the most common form of kidney cancer.

The standard treatment for metastatic or advanced renal cell carcinoma is molecular targeted drug therapy, which is designed to interfere with the specific molecules necessary for tumour growth and progression.

Despite this, it remains a disease for which patients have very few treatment options. 

Everolimus is a treatment recommended by the National Comprehensive Cancer Network guidelines as a 2nd-line therapy for unresectable advanced or metastatic renal cell carcinoma.

Currently, no combination therapy for this indication has been approved anywhere in the world.

“For people with renal cell carcinoma, these data represent an encouraging step forward. In particular, the potential benefit in progression free survival will be welcomed by patients and clinicians alike, as this is an area of significant unmet need. Current treatment options often have a limited duration of benefit and these positive results show the potential role of lenvatinib in patients with advanced kidney cancer,” commented James Larkin, Consultant Medical Oncologist at The Royal Marsden Hospital, London.

Reference

The data was presented in an oral session at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) on Monday 1 June at 11:45 CST (Abstract No. 4506).

Source: Eisai