KISPLYX (lenvatinib), tyrosine kinase inhibitor

Insufficient clinical benefit to justify reimbursement for advanced kidney cancer in combination with everolimus.

• KISPLYX has been granted a marketing authorisation in combination with everolimus for the treatment of adults suffering from advanced kidney cancer having received prior anti-VEGF (vascular endothelial growth factor) therapy.

• Progression-free survival was improved compared to everolimus alone (absolute gain of 9.1 months), with a lack of benefit in terms of overall survival.

• The safety profile of the lenvatinib/everolimus combination is less favourable than that of everolimus alone.

• KISPLYX in combination with everolimus has no role in the therapeutic strategy for advanced kidney cancer, particularly given:

  - the recent presence in the therapeutic arsenal of medicinal alternatives (nivolumab and cabozantinib) that have demonstrated a benefit in terms of overall survival compared to everolimus as second-line and subsequent treatments in phase III studies,

  - the lack of data on the use of KISPLYX in combination with everolimus after failure of nivolumab and cabozantinib.