On July 21, 2013 Aduro BioTech reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its pancreatic cancer combination treatment that consists of its CRS-207 and GVAX Pancreas immunotherapies (Press release Aduro BioTech, JUL 21, 2014, View Source [SID:1234500634]). According to the FDA, a breakthrough therapy designation is for a drug that treats a serious or life-threatening condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies.

The designation was based on findings from a Phase 2 trial in metastatic pancreatic cancer patients, which were presented and featured earlier this year at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium conference. The randomized, controlled, multi-center study, which enrolled 93 patients who failed or refused prior therapy, demonstrated a statistically significant survival benefit in patients receiving the combination of GVAX Pancreas and CRS-207 cancer vaccines (Arm A) compared to GVAX Pancreas vaccine alone (Arm B). The median overall survival of the patients receiving the combination was 6.1 months compared to 3.9 months for those receiving GVAX monotherapy (HR=0.59, one-sided p=0.0172).

“We are extremely pleased to receive Breakthrough Therapy Designation and the high degree of FDA collaboration toward advancement of our program that it confers,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “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.”