Late stage cancer drug failure for AstraZeneca
pharmafile | September 27, 2010 | News story | Sales and Marketing | AstraZeneca, prostate cancer, zibotentan
AstraZeneca’s oncology pipeline has suffered a further blow after prostate cancer drug zibotentan failed to meet its primary endpoint of increasing overall survival in a phase III trial.
The news rounds off a bad 12 months for the company and follows the failure of colon cancer treatment Recentin earlier this year and lung cancer treatment vandetanib in late 2009.
AstraZeneca said in a statement that it “plans no regulatory submissions for zibotentan at this time,” based on the latest study results.
The company previously planned to file for US and European approvals in the first half of next year, and earlier this year described the drug as part of a ‘next wave’ of products that would help drive its business in the short-to-medium term.
The novel once-daily oral treatment for men was being tested against metastatic castration resistant prostate cancer (CPRC) and its latest results come from Study 14.
This was a randomised, placebo-controlled phase III study that evaluated zibotentan 10mg, added to the standard treatment of care, in 600 patients with CRPC.
Part of the ENTHUSE trial, which involved over 3,000 men with CRPC, AstraZeneca says it will publish the full results of Study 14 next year.
Meanwhile, two other zibotentan studies will continue. Study 15 will evaluate zibotentan versus placebo in men whose disease has not yet metastasized, and Study 33 will evaluate the drug plus chemotherapy versus chemotherapy alone in men whose disease has spread and are being treated with chemotherapy.
Current treatments for prostate cancer include AstraZeneca’s own Zoladex (goserelin), an injectable treatment for CRPC that restricts levels of testosterone.
Also on the market is Dendreon’s prostate cancer treatment Provenge, a therapeutic vaccine that stimulates the body’s immune system to ‘attack’ cancer cells and which won US regulatory approval in May.
Zibotentan is designed to help patients who no longer respond to treatments that block the action of testosterone, a hormone driving cancer growth and the standard mechanism of action for current treatments.
Instead it works by blocking the endothelin pathway, which drives the spread of cancer growth, and by blocking the receptor in this pathway AstraZeneca hopes to show zibotentan can slow both tumour growth and the spread of cancer cells.
Ben Adams
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