The mTOR inhibitor is indicated for use, in combination with exemestane, in postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer that has recurred or progressed following treatment with a non-steroidal aromatase inhibitor.
Approval for the new indication was based on results from a randomised, double-blind, multicentre phase III study (BOLERO-2) involving 724 postmenopausal women with advanced hormone receptor positive, HER2-negative breast cancer who had experienced recurrence or progression following therapy with letrozole or anastrozole.
In the interim analysis by local investigators, treatment with everolimus 10mg once daily plus exemestane 25mg once daily more than doubled median progression-free survival (PFS) to 6.9 months, compared with 2.8 months for exemestane alone (HR=0.43 [95% CI: 0.35–0.54]; p<0.001). Central analysis showed that everolimus plus exemestane extended median PFS to 10.6 months compared with 4.1 months for exemestane alone (HR=0.36 [95% CI: 0.27–0.47]; p<0.001). Response rates and clinical benefit rates were also significantly higher in patients treated with both everolimus and exemestane.
Afinitor is also indicated for the treatment of advanced pancreatic neuroendocrine tumours in patients with unresectable or metastatic disease and advanced renal cell carcinoma that has progressed during or after VEGF-targeted therapy.
View Afinitor drug record
Further information: Novartis
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