Amgen has been forced to halt a late-stage trial of its experimental pancreatic cancer drug ganitumab following a recommendation from an independent data monitoring committee.
The drug was involved in an 825-patient Phase II trial investigating the combination of ganitumab with Eli Lilly’s Gemzar as a treatment for metastatic pancreatic cancer. However, Amgen halted the trial after a planned interim analysis.
During the analysis, the data monitoring committee concluded that the combination was unlikely to significantly improve the overall survival of patients in comparison to Gemzar monotherapy.
As a result, Amgen has also halted further trials involving ganitumab, including a Phase II trial investigating the drug’s efficacy in treating locally-advanced pancreatic cancer.
Regarded as one of the most promising pancreatic cancer treatments in late-stage development, the clinical trial failure has come as a disappointment to Amgen. The company has, however, moved to confirm that no safety concerns were raised, with Amgen set to explore other options for the drug. These include its use in combination with another drug, or in treating another segment of pancreatic cancer patients.
The scrapping of the trial will also come as a blow to Japan-based Takeda Pharmaceutical who co-sponsored the study and retains the right to develop and commercialise ganitumab in Japan through a collaboration agreement with Amgen.
Amgen has noted the unmet need for pancreatic cancer treatments, as efforts tend to be focused on more prevalent diseases such as breast or lung cancer. Pancreatic cancer is stereotypically far more aggressive than other forms, with low five-year survival rates and limited treatment options.