Amgen has stopped all clinical trials of its gastric cancer candidate rilotumumab after seeing an increase in patient deaths with the drug.
Rilotumumab – a monoclonal antibody designed to inhibit the hepatocyte growth factor/scatter factor (HGF/SF):MET pathway – was in two phase III trials involving patients with advanced gastric cancer.
The drug had once been predicted to have the potential to make $1bn a year or more in sales by 2023, thanks in part to the lack of new candidates for gastric cancer coming through the development pipeline.
The decision terminate the programme was “based on a planned safety review by the RILOMET-1 independent data monitoring committee that found an increase in the number of deaths in the rilotumumab and chemotherapy treatment arm when compared to the chemotherapy treatment only arm,” said Amgen.
Rilotumumab was designed to improve the efficacy of chemotherapy by reducing tumour proliferation, blocking survival signals and preventing the migration and invasion of malignant cells.
The decision is also a blow to Japanese pharma company Astellas, as rilotumumab was one of a series of Amgen drug candidates that formed the basis of a strategic alliance between the two companies announced last year.
“While we are disappointed with these results, we will work with lead investigators to further analyse the data in order to help inform future research and therapies in this area,” said Amgen’s vice president of R&D Sean Harper.
“There is a high unmet need for new treatments to address advanced gastric cancer, one of the leading causes of cancer death worldwide,” he added.
Another drug acting via the HGF/SF:MET pathway – Roche/Genentech’s onartuzumab – suffered a setback earlier this year although in this case the problem was a lack of efficacy in a phase III trial involving patient with non-small cell lung cancer.
The drug remains in development in other cancers, including gastric cancer, according to Genentech’s pipeline listing.