An analysis by an independent monitoring committee concluded that the therapy, ganitumab, or AMG 479, probably wouldn’t improve survival of patients with metastatic pancreatic cancer, Thousand Oaks, California-based Amgen said today in a statement. Amgen and partner Takeda Pharmaceutical Co. (4502), based in Tokyo, were testing ganitumab with the chemotherapy gemcitabine against gemcitabine alone.
Ganitumab, in the third and final round of human trials typically required for U.S. regulatory approval, targeted the type 1 insulin-like growth factor receptor, which regulates cell growth. Several drugmakers have seen failures of cancer drugs targeting the IGF receptor, including Pfizer Inc.’s figitumumab, Sanofi’s AVE 1642 and Roche Holding AG’s RG1507.
“This is yet another reason why we believe Amgen needs to be more prudent with R&D expense and raise its hurdle for go/no- go decisions,” Michael Yee, an analyst at RBC Capital Markets, wrote today in a note to clients. “Once again, this shows why predicting Phase III from small Phase II studies in solid tumors is risky, particularly in difficult-to-treat and aggressive cancers such as pancreatic where failure is common.”
About 44,000 new cases of pancreatic cancer will be diagnosed in the U.S. this year and the disease will kill about 37,390 patients, according to the National Cancer Institute.
Separate Study
Amgen also is canceling a separate Phase 2 trial for patients with locally advanced pancreatic cancer, the company said in the statement.In light of the study’s failure, Amgen is now reviewing its other trials testing the drug including colorectal and small- cell lung cancer, Christine Regan, a spokeswoman, said in an e- mail.
“These disappointing results underscore the difficulty of treating pancreatic cancer, which remains a major unmet medical need,” Sean Harper, executive vice president of research and development at Amgen, said in the statement.
Amgen fell less than 1 percent to $81.03 in extended trading after the close in New York.
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
