Recentin disappoints in colorectal cancer
pharmafile | March 9, 2010 | News story | Research and Development | AZ, Cancer, Recentin, colorectal cancer
AstraZeneca’s developmental oncology drug Recentin has failed to meet its primary endpoint in a phase II/III study.
The once-daily oral Recentin (cediranib) was compared with Roche’s Avastin (bevacizumab) in patients with first-line metastatic colorectal cancer.
It is a blow for AstraZeneca, admits Alan Barge, the company’s head of oncology: “While we recognised that challenging Avastin would be a high hurdle, it is still disappointing, despite evidence of clinical activity with Recentin, not to have met the primary endpoint.”
HORIZON III compared each drug in combination with chemotherapy, finding no statistically significant difference between treatment arms.
All patients received oxaliplatin-based chemotherapy and either 20 mg of Recentin or 5 mg/kg of Avastin by IV infusion every two weeks.
However, Recentin was inferior in terms of progression-free survival – and this was the agreed primary endpoint.
AstraZeneca has a further chance for the drug to make its mark, with
another study, the double-blind, randomised HORIZON II, comparing Recentin with chemotherapy versus chemotherapy alone.
Data from both of these studies will be submitted to a medical meeting in the second half of the year.
“The results of the second pivotal study in the coming months will provide further information on whether Recentin may provide benefit for patients with colorectal cancer and will inform any decision about possible regulatory filings,” said Barge.
HORIZON II’s primary endpoints are progression-free and overall survival.
Recentin is an anti-angiogenic compound that inhibits all three vascular endothelial growth factor (VEGF) receptors, acting on
blood and lymphatic vessels to inhibit the spread of a tumour.
Other studies with the drug are ongoing in various tumours, with results from REGAL, a Phase III trial to treat recurrent glioblastoma, expected before the summer.
This is a three-arm randomised study of Recentin alone or in combination with chemotherapy drug lomustine compared to lomustine alone.
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