|Amgen R&D chief Dr. Sean Harper|
Amgen ($AMGN) is calling off all clinical studies on rilotumumab in advanced gastric cancer after a peek at Phase III data revealed that the drug was actually making matters worse for patients, further marring the value of the company's oncology pipeline.
In a scheduled safety review of RILOMET-1, a Phase III trial on the former AMG 102, Amgen's independent data monitoring committee noted an increase in the number of deaths among patients in the rilotumumab plus chemotherapy arm compared to those on chemo alone, the company said. That trend likely would have met the study's protocol-defined futility criteria if investigators let the study ride out until a March interim analysis, Amgen said, so the Big Biotech is pulling the plug on the whole gastric program, which includes a second Phase III study called RILOMET-2.
That likely spells the end of the road for rilotumumab, an antibody designed to block one of the growth factors integral to tumor cell proliferation. Amgen has disclosed no other potential indications for the drug beyond gastric cancer, and, in announcing the Phase III failure, the company is pointing to no silver lining or subpopulation promise.
"While we are disappointed with these results, we will work with lead investigators to further analyze the data in order to help inform future research and therapies in this area," R&D Chief Dr. Sean Harper said in a statement. "There is a high unmet need for new treatments to address advanced gastric cancer, one of the leading causes of cancer death worldwide."
Rilotumumab's dropout is a blow to the company's late-stage cancer pipeline, as Amgen had hoped to read out Phase III data on the drug by next year and potentially hand in an FDA application thereafter. With that program hobbled, Amgen's oncology division is awaiting the FDA's decision on blinatumomab, an immunotherapy targeting lung cancer, and T-Vec, a cancer vaccine candidate that has performed well against melanoma. Behind those is the ovarian cancer treatment trebananib, which this month failed to significantly improve overall survival after previously coming through on progression-free survival.
Meanwhile, Amgen is in the midst of slashing its payroll by 20% in response to investors and analysts unimpressed with the company's penchant for spending big on moon shot R&D projects that end up failing short of the finish line. A chorus of Wall Streeters, including Bernstein analyst Geoffrey Porges and activist investor Daniel Loeb, have called for the company to split in two, a move that would put its established products in the hands of a high-margin drug retailer and place its big R&D bets with a nimbler biotech operation. The company has largely waved off the suggestion but maintains that it will always welcome "constructive input toward our common goal of enhancing shareholder value."
- read the statement