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FDA grants breakthrough status to immunotherapy combination for pancreatic cancer
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The FDA today granted breakthrough therapy designation to the combination of two immunotherapies — CRS-207 and GVAX Pancreas — for the treatment of metastatic pancreatic cancer, according to Aduro BioTech, the combination treatment’s manufacturer.
The combination of GVAX, an irradiated, granulocyte-macrophage colony–stimulating factor vaccine, and CRS-207, an immunotherapy vaccine containing live-attenuated Listeria monocytogenes bacteria, induces a potent innate and T-cell–mediated immune response.
“We are extremely pleased to receive Breakthrough Therapy Designation and the high degree of FDA collaboration toward advancement of our program that it confers,” Stephen T. Isaacs, chairman, president and CEO of Aduro, said in a press release. “This designation underscores the potential of our combination immunotherapy approach to make a difference in the lives of patients with pancreatic cancer, which remains a very difficult cancer to treat. We are encouraged by our phase 2 results and look forward to completing enrollment in our phase 2b ECLIPSE trial by end of 2015.”
The designation was based on data from an ongoing phase 2 study of 93 patients with metastatic pancreatic cancer who failed or refused prior therapy, which were presented at the ASCO Gastrointestinal Cancers Symposium conference.
According to study results, patients who received the combination of GVAX Pancreas and CRS-207 cancer vaccines demonstrated a statistically significant survival benefit vs. patients who received GVAX Pancreas vaccine alone.
The median OS of the patients receiving the combination was 6.1 months vs. 3.9 months for those receiving GVAX monotherapy (HR=0.59; one-sided P=.0172).
The FDA grants breakthrough therapy designation to expedite the approval process of drugs used to treat life-threatening or serious diseases that may demonstrate substantial improvement over existing therapies.
The ongoing ECLIPSE trial will evaluate the safety, immune response and efficacy of the combination immunotherapy vs. chemotherapy or to CRS-207 alone in 240 patients with metastatic pancreatic cancer who have progressed after at least one line of therapy. The primary endpoint of the trial is OS.