GVAX Pancreas cancer vaccine regulatory update

Aduro said FDA granted breakthrough therapy designation to the combination of CRS-207 and GVAX Pancreas cancer vaccine to treat pancreatic cancer. The designation was based on data from a Phase II trial of the combination in metastatic pancreatic cancer patients. Last year, Aduro reported that CRS-207 plus GVAX Pancreas and cyclophosphamide met the primary endpoint of improving overall survival (OS) vs. GVAX Pancreas and cyclophosphamide alone (6 vs. 3.4 months, p=0.0114) (see BioCentury, May 27, 2013). Aduro is conducting the Phase IIb ECLIPSE trial comparing CRS-207 plus GVAX Pancreas and low-dose cyclophosphamide vs. CRS-207 alone or chemotherapy in metastatic pancreatic cancer patients who have progressed after >=1 line of therapy. ECLIPSE is slated to complete enrollment by the end of 2015.

GVAX Pancreas, which has completed a Phase II trial to treat operable pancreatic cancer, is an allogeneic cancer vaccine engineered to secrete GM-CSF. GVAX Pancreas has Orphan Drug designation in the U.S. to treat pancreatic cancer. CRS-207, which is in Phase II testing to treat metastatic pancreatic cancer, is a live attenuated strain of Listeria monocytogenes that expresses human mesothelin. ...