The future of Bristol-Myers Squibb's investigational cancer drug brivanib is hanging in the balance after it failed a phase III trial in advanced hepatocellular carcinoma (HCC).
Brivanib (formerly BMS-582664) failed to meet the primary endpoint of non-inferiority to Bayer/Onyx Pharmaceuticals' Nexavar (sorafenib) as a first-line treatment for HCC, a form of liver cancer, in patients who had not received any prior treatment for the disease.
This is not the first disappointment in brivanib's development programme. In December, 2011, BMS reported that the drug was unable to improve overall survival in another trial in HCC involving patients whose cancer had progressed despite earlier treatment with Nexavar.
Ahead of that trial failure analysts had predicted sales for brivanib of around $250m to $450m a year by 2020.
BMS said in a statement that it is "considering options" for the ongoing development of brivanib, which is an oral inhibitor of vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR).
Previously, the company had said it planned to file for approval of brivanib in the US and Europe this year.
The BRISK-FL study in HCC is one of a number being carried out on brivanib, which is also being studied as an adjuvant therapy in HCC, as well as in renal cell carcinoma, colorectal cancer and cervical cancer.
In the past, BMS has identified brivanib as one of five late-stage compounds it is hoping will help it plug the revenue gap now that blockbuster anticoagulant Plavix (clopidogrel) is starting to be affected by generic competition.
The company also experienced a late-stage pipeline disappointment recently when the FDA asked for more information on Eliquis (apixaban), a novel anticoagulant in development as a preventative treatment for stroke and systemic embolism in patients with non-valvular atrial fibrillation partnered with Pfizer.
Commenting on the outcome of the latest study, BMS' senior vice president of global development and medical affairs, Brian Daniels, said: "The treatment options for patients with advanced HCC are limited, and we are disappointed that the primary endpoint was not met."