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Vaccine Combo Gains ‘Breakthrough Therapy’ Status for Treatment of Pancreatic Cancer
The FDA has granted a “breakthrough therapy” designation for an investigational pancreatic cancer combination treatment consisting of GVAX Pancreas and CRS-207 immunotherapies (Aduro Biotech, Inc.).
According to the FDA, “breakthrough therapy” status is given to a drug that treats a serious or life-threatening condition when preliminary clinical evidence indicates that the treatment may demonstrate substantial improvement on a clinically significant endpoint compared with available therapies.
The designation was based on findings from a phase II trial in patients with metastatic pancreatic cancer, which were presented earlier this year at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium conference.
The randomized, controlled study demonstrated a statistically significant survival benefit in patients receiving the combination of GVAX Pancreas and CRS-207 cancer vaccines compared with GVAX Pancreas vaccine alone in 93 patients who failed or refused prior therapy. The median overall survival of the patients receiving the combination treatment was 6.1 months compared with 3.9 months for those receiving GVAX monotherapy (hazard ratio, 0.59; P = 0.0172).
A phase IIb clinical trial (ECLIPSE) is being conducted in 240 patients with metastatic pancreatic cancer who have progressed after at least one line of therapy. The randomized, controlled, three-arm study will involve sites in the U.S. and Canada and will evaluate the safety, immune response, and efficacy of combination immunotherapy with GVAX Pancreas and CRS-207 compared with chemotherapy or CRS-207 alone. The study’s primary endpoint is overall survival.
The GVAX Pancreas vaccine is derived from human cancer cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine. GVAX Pancreas also expresses mesothelin.
The CRS-207 vaccine is based on a live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform, which induces an innate and T-cell–mediated immune response. The vaccine has been designed to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers, including mesothelioma and pancreatic, non–small-cell lung, ovarian, and gastric cancers.
Source: Aduro Biotech, Inc.; July 21, 2014.