Patient Deaths Move Amgen To Pull Drug From Stomach Cancer Trials

Xconomy Seattle — 

[Corrected 11/25/14, 3:00 pm. See below.] Thousand Oaks, CA-based Amgen said Monday it has halted all use of its experimental antibody therapy rilotumumab. [A previous version of this story said rilotumumab was developed at Immunex, which Amgen acquired in 2002. The drug was in fact developed at Amgen’s main campus. We regret the error.]

An independent review of one of its Phase 3 studies showed more people died using a combination of rilotumumab and chemotherapy than from simply using chemotherapy.

The antibody therapy was being studied in a subset of advanced gastric cancer patients whose tumors produced an abundance of a protein called cMET. The Phase 3 data were expected next year. Amgen executive vice president of R&D Sean Harper said in a statement that the company would analyze the data to “help inform future research and therapies in this area.”

It’s not the first time the drug has had a setback. Rilotumumab was once shelved because of poor Phase 2 data, but Amgen put it back on track in 2012 after finding better results in the cMET-positive patient group.

Others are exploring the same pathway to treat gastric cancer. Roche is developing onartuzumab (MetMab) to treat several cancers, with a Phase 3 trial for stomach cancer in progress.

Stomach cancer, also called gastric cancer, kills about 723,000 people a year worldwide. In the U.S., it will represent 1.3 percent of all cancers diagnosed in 2014, according to a National Cancer Institute estimate. Once diagnosed, prognosis isn’t favorable. About 28 percent of patients survive five years, although NCI says new diagnoses and deaths have been in steady decline, and survival rates have been climbing over the years.

The field got two boosts earlier this year. First, Eli Lilly received FDA approval for ramucirumab (Cyramza) as a single agent to treat advanced stomach cancer; it just recently got a second FDA nod to use the drug in combination with the chemotherapy paclitaxel.

Second, the Cancer Genome Atlas, a project of the U.S. National Institutes of Health, published research showing four distinct subtypes of stomach cancer, giving more momentum to the push for targeted therapies.

One of the subtypes, about 9 percent of all tumors tested, showed the presence of Epstein-Barr virus, which causes mononucleosis and is suspected of causing other types of cancer. The EBV-positive tumor samples also had genetic alterations that might suggest the use of drugs already in development to block proteins related to the PI3-kinase, JAK2, and PD-1/PD-L1 genes.

The public markets took Amgen’s rilotumumab news in stride. The company’s stock price was up $1.51 in morning trading to $164.32.