Amgen ($AMGN) iced a late-stage program to develop ganitumab (AMG 479) to fight a form of pancreatic cancer, adding to a growing list of Phase III disasters from major drugmakers this week. The Thousand Oaks, CA-based company decided to scrap a trial testing the drug in combination with standard therapy gemcitabine in cases of pancreatic adenocarincoma that had spread, because the treatment showed weak signs of improving survival of patients with the aggressive cancer, Amgen said Wednesday afternoon.
Sizable gambles on late-stage programs such as the Phase III GAMMA trial for ganitumab drove up Amgen's R&D spending last year and prompted the large biopharma group to restructure. Ganitumab, a monoclonal antibody against type 1 insulin growth factor receptor, turned out to be a losing bet in the trial, as independent data monitors pushed for Amgen to end the study because an interim analysis showed the drug was unlikely to beat placebo in providing a worthy increase in overall survival.
At the same time, Amgen has decided to pull the plug on a mid-stage study of ganitumab in locally advanced pancreatic cancer. This year the National Cancer Institute expects 43,920 new cases 37,390 deaths from pancreatic cancer. The disease grabbed the spotlight last year after ex-Apple ($APPL) chief Steve Jobs succumbed to a form of pancreatic cancer. Biotechs have been testing a variety of approaches to treat malignancies of the key digestive organ but with limited success.
"These disappointing results underscore the difficulty of treating pancreatic cancer, which remains a major unmet medical need," Sean Harper, Amgen's top R&D executive, said in a statement. His company is sending word to investigators to take patients off the drug, though there were no safety red flags that prompted the termination of the study.
Amgen has developed ganitumab with partner Takeda Pharmaceuticals, the Japan-based pharma heavyweight. The failure follows those of similar drugs from Pfizer ($PFE), Sanofi ($SNY), and Roche ($RHHBY), Bloomberg reported, and RBC Capital Markets analyst Michael Yee questioned whether Amgen made the right call to advance ganitumab into late-stage development.
Despite the significant setback with ganitumab, Harper's development group can redeem itself later this year with successful results of a Phase III trial of its engineered cold sore virus talimogene laherparepvec (OncoVex) in patients with melanoma.
- here's the release
Special Report: Ganitumab - Biotech's 5 key attacks on pancreatic cancer
Editor's note: Updated with additional details on ganitumab's ownership and background on drugs that target type 1 insulin growth factor receptor.
Related conversation on Twitter :
"The big pharma flops keep on coming": Reaction to Amgen's failed Phase III pancreatic cancer program.
Input from @RyanMFierce, @JohnCFierce, @FierceBiotech, others
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