U.K. researchers report big immunotherapy flop for long-sought cancer vaccine

Not all the immunotherapies have impressed at ASCO in Chicago. A large Phase III study of the immunotherapy GV1001 showed an insignificant difference in overall survival between pancreatic cancer patients treated with the experimental treatment and those taking standard chemotherapy.

Advanced pancreatic malignancies present major challenges for new cancer drugs, and the failure of GV1001 adds to a long list of setbacks in the pursuit of treatments. To be clear, GV1001 is a telomerase peptide "vaccine" and has been around the biotech block for years with a mixed history of success and failure in the clinic. It's not to be confused with the class of new immunotherapies from Merck ($MRK), Bristol-Myers Squibb ($BMY) and Roche ($RHHBY) that have dominated the headlines from ASCO thus far for impressive results in studies involving a range of tumors.

Cancer Research UK backed the 1,062-patient study of GV1001 in the Phase III "TeloVac" trial, hoping to boost survival for patients with tough-to-treat cases of pancreatic cancer. Though the experimental therapy failed to extend the lives of patients significantly better than chemo in the late-stage trial, researchers identified potential biomarkers that could be used to match the therapy with a subgroup of responders. They also found anti-inflammatory effects of treatment. So we may not have heard the last of GV1001.

Korean biotech Kael-GemVax controls the rights to GV1001, which Kael acquired from Norway's Pharmexa in 2008. Pharmexa has previously tested the peptide-based vaccine, which is designed to spur immune attacks on cancer cells, in pancreatic cancer. And failed. Pharmexa reported that it terminated a Phase III study of GV1001 compared with Gemcitabine chemo in pancreatic cancer after preliminary data showed no survival benefit for patients on the cancer vaccine.

It's unclear what the expectations were for TeloVax after the termination of the Pharmexa-sponsored Phase III years ago.

Michelle Kim, Kael-GemVax's CEO, highlighted the silver lining in the Phase III study from the U.K. "While we are disappointed that the vaccine did not result in a significant survival advantage, we are encouraged by the finding of two possible biomarkers that may predict response to the vaccine and increased survival in a subgroup of patients," Kim stated. "Furthermore, we are excited to see that an anti-inflammatory effect was seen in the trial, a finding that reinforces research that is currently being conducted at Kael-GemVax."

- here's the release

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