Late-stage failure for Afinitor
pharmafile | August 8, 2013 | News story | Research and Development, Sales and Marketing | Afinitor, Cancer, Novartis, liver
Novartis’ oncology programme has received a blow with the news that Afinitor has failed to help patients live longer in a Phase III trial for advanced liver cancer – which means the company will abandon planned filings in this indication.
Afinitor (everolimus), already approved to treat breast and other cancers in Europe and the US, did not meet its primary endpoint of overall survival – compared to placebo – in patients with the most common form of liver cancer in the EVOLVE-1 study.
“While we are disappointed with these results, Novartis remains committed to studying everolimus through a robust research and development programme to address unmet needs in different types of cancer,” insisted Alessandro Riva, global head, oncology development & medical affairs, Novartis Oncology.
The drug did not extend overall survival in patients with locally advanced or metastatic hepatocellular carcinoma (HCC) after progression on, or intolerance to, Bayer’s cancer treatment Nexavar (sorafenib) – the brand to beat in this area.
Novartis has other options: Afinitor is currently enmeshed in a wide-ranging Phase III development programme which sees it being tested in gastrointestinal and lung neuroendocrine tumors (NET), lymphoma and tuberous sclerosis complex (TSC).
Results from these trials are expected to be published in 2014 and 2015.
EVOLVE-1 involved 546 patients across 156 sites worldwide, with patients randomised to receive Afinitor 7.5 mg each day plus best care or placebo.
Secondary endpoints included time to tumour progression, disease control rate, time to deterioration of performance status, safety and quality of life.
Afinitor is approved in the US and EU in advanced renal cell carcinoma following progression on, or after, vascular endothelial growth factor (VEGF)-targeted therapy, as well as for locally advanced, metastatic or unresectable progressive neuroendocrine tumours of pancreatic origin.
It is also authorised in Europe for hormone receptor-positive, HER2 negative (HR+/HER2 negative) advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Meanwhile in the US it has the green light for postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer with exemestane after failure of treatment with letrozole or anastrozole.
Adam Hill
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