The randomized, controlled three-arm trial is expected to enroll over 300 patients at 21 clinical trial sites in
"Given the very difficult-to-treat nature of metastatic pancreatic cancer, we are pleased with the DMC's recommendation to continue the ECLIPSE trial without modification following their review of interim data," said
Last year, the
Breakthrough Therapy designation was granted based on results from a Phase 2a clinical trial of patients with metastatic pancreatic cancer treated with CRS-207 and GVAX Pancreas. The multi-center trial, which enrolled 93 patients with metastatic pancreatic cancer, demonstrated a statistically significant survival benefit in patients receiving the combination immuno-oncology regimen of CRS-207 and GVAX Pancreas compared to GVAX Pancreas alone. The results were published in the
Results of the Phase 2a clinical trial published in JCO indicated the median overall survival of Arm A patients receiving the combination regimen of CRS-207 and GVAX Pancreas was 6.1 months compared to 3.9 months for Arm B patients receiving GVAX monotherapy (HR=0.5930, one-sided p=0.0172). One-year survival probability for patients in Arm A was 24 percent compared with 12 percent for patients in Arm B. The trial enrolled advanced-stage metastatic pancreatic cancer patients who previously received or refused prior chemotherapy, with most patients having received two or more prior therapies in the metastatic setting. Patients were randomized in a 2:1 ratio to receive two doses of GVAX Pancreas vaccine followed by four doses of CRS-207 (Arm A) or to receive six doses of GVAX Pancreas vaccine alone (Arm B). Clinically stable patients were allowed to receive additional treatment courses.
Of the 93 patients enrolled, the most frequent treatment-related Grade 3 or 4 adverse event (AE) was asymptomatic, transient lymphopenia, with three patients experiencing Grade 3 lymphopenia and two patients experiencing Grade 4 lymphopenia. There were no other Grade 4 AEs, and there were no other Grade 3 AEs with frequencies higher than five percent in either arm. The most common Grade 3 AEs were transient lymphopenia, fevers, elevated liver enzymes and fatigue.
CRS-207 is one of a family of product candidates based on Aduro's live-attenuated, double-deleted (LADD) Listeria monocytogenes immuno-oncology platform that are designed to induce potent innate and adaptive immune responses. CRS-207 has been engineered 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.
About GVAX Pancreas
GVAX Pancreas is one of a family of GVAX vaccines derived from human cancer cell lines that are genetically modified to express granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune system-stimulating cytokine. GVAX Pancreas is derived from human pancreatic cancer cell lines and is designed to activate specific T cell immunity to pancreatic cancer antigens, including mesothelin.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for CRS-207 in combination with GVAX Pancreas, plans and timing of our ECLIPSE clinical trial and the potential for eventual regulatory approval, commercialization and launch of our product candidates. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "would," "project," "plan," "expect" or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our technology platforms to build a pipeline of product candidates, our dependence on our lead product candidate, CRS-207, and GVAX Pancreas, our ability to obtain and maintain regulatory approval of our product candidates, our inability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, and our ability to obtain and adequately protect intellectual property rights for our product candidates. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in the most recent Form 10-Q which is on file with the
Sylvia WheelerSVP, Corporate Affairs 510 809 9264 Media Contact: Angela Bitting925 202 6211 email@example.com