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Results in on Double Punch Vaccine: Why the FDA Granted Orphan Status to CRS-207 + GVAX in Pancreatic Cancer

A quick note related to an earlier Pancreatica blog posting from October 24, 2013.

At the 2014 Gastrointestinal Cancers Symposium in San Francisco (January 16-18) as hosted by the American Society of Clinical Oncology (ASCO), the results of an interesting vaccine study for pancreatic cancer (ductal adenocarcinoma of the pancreas) were released.

By way of background in the fall 2013, the U.S. Food and Drug Administration (FDA) had granted orphan drug status to the sequential double immunotherapy (vaccine) combination of CRS-207 plus GVAX – without giving openly available data as to the reason for the approval of this regimen for advanced pancreatic cancer.

These results were forthcoming at January’s ASCO Gastrointestinal Cancers Symposium.  This was the product of a Phase II study by Johns Hopkins researchers comparing the results of a single vaccine (GVAX) with those of CRS-207, a live but attenuated Listeria monocytogenes strain aimed at mesothelin plus GVAX, a biologic that stimulates the immune system’s granulocyte-macrophage colony-stimulating factor (GM-CSF).

This vaccine combination demonstrated a median overall survival of 6.1 months for patients with metastatic pancreatic cancer which compared favorably to those who received GVAX alone (3.9 months). Also, the one-year survival rate was 24% for patients with the combination in contrast with 12% of those treated with GVAX only.

Additionally, there was a kind of dose-response effect in that overall survival was increased for those patients with metastatic pancreatic cancer who received three or more doses of the combination vaccine (9.7 months) versus those who received less (4.6 months). And the tumor marker CA19-9 improved significantly in greater a greater number of patients who received the combination vaccine.

Finally, the researchers noted that the side effects of the double vaccine tended to be mild, tolerable, and rather easily resolvable.

One point that should probably be noted is that some of the Johns Hopkins researchers appear to have a financial interest related to these drug agents or in the company that supports them: Aduro BioTech Inc. of Berkeley, California.

These results do not yet appear to be published but there is a bit More Here

Addendum April 2015


Dale O’Brien, MD