The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Aduro BioTech’s pancreatic cancer combination treatment that consists of its CRS-207 and GVAX Pancreas immunotherapies.
The FDA’s Breakthrough therapy designation for the pancreatic cancer combination immunotherapy was based on data from a randomised Phase II clinical study, which enrolled 93 metastatic pancreatic cancer patients who failed or refused prior therapy.
Aduro BioTech presented the findings from the multi-centre Phase II trial earlier this year at the ASCO Gastrointestinal Cancers Symposium conference.
According to the company, the study showed a statistically significant survival benefit in patients receiving the combination of GVAX Pancreas and CRS-207 cancer vaccines (Arm A) compared with GVAX Pancreas vaccine alone (Arm B).
The median overall survival of the patients receiving the combination was 6.1 months compared with 3.9 months for those receiving GVAX monotherapy.
Aduro president and CEO Stephen Isaacs said: "We are extremely pleased to receive breakthrough therapy designation and the high degree of FDA collaboration toward advancement of our programme that it confers.
"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 enrolment in our Phase 2b ECLIPSE trial by end of 2015."
Currently, Aduro is conducting a randomised, controlled, Phase IIb clinical trial in metastatic pancreatic cancer patients who have progressed after at least one line of therapy.
The study is designed to assess the safety, immune response and efficacy of the combination immunotherapy of GVAX Pancreas and CRS-207 compared to chemotherapy or to CRS-207 alone.
The three-arm study will involve 240 patients at over 20 clinical trial sites in the US and Canada. Overall survival is the primary endpoint of the trial.
CRS-207 is one of a family of product candidates based on the company’s live-attenuated, double-deleted Listeria monocytogenes immunotherapy platform which induce a potent innate and T cell-mediated immune response.