On February 26, 2015 Aduro Biotech reported the initiation of an investigator-sponsored Phase 2 clinical trial of the company’s immuno-oncology product candidates GVAX Pancreas and CRS-207 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab), a monoclonal antibody against programmed death-1 receptor (PD-1) (Press release, Aduro BioTech, FEB 26, 2015, View Source [SID:1234502260]). The first patient has been enrolled in the trial that will be conducted at up to five U.S. clinical trial sites.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
GVAX Pancreas and CRS-207 are designed to stimulate an immune response against a tumor, and nivolumab is designed to remove an immuno-suppressive mechanism that cancer cells have developed against the immune system. Aduro believes the combination of CRS-207 and GVAX Pancreas with nivolumab may improve clinical outcomes because of their complementary mechanisms of action.
The randomized, controlled STELLAR trial (Safety and Therapeutic Efficacy of Live-attenuated Listeria/GVAX with Anti-PD1 Regimen) will enroll approximately 88 adults with metastatic pancreatic cancer who have had one prior chemotherapy regimen for metastatic disease. The trial will include two arms: Arm A with CRS-207/GVAX Pancreas vaccine and nivolumab and Arm B with CRS-207/GVAX Pancreas vaccine. The primary objective of this study is to compare the overall survival (OS) of patients in Arm A and Arm B. Secondary endpoints include evaluation of clinical and immune response and safety. For more information, please visit ClinicalTrials.gov (Identifier: NCT02243371).
The trial is supported by Stand up to Cancer (SU2C)-Lustgarten Foundation Pancreatic Cancer Convergence Dream Team Translational Research; Pancreatic Cancer Action Network – AACR (Free AACR Whitepaper) Research Acceleration Network Grant, supported by Fredman Family Foundation; and Bristol-Myers Squibb. SU2C is a program of the Entertainment Industry Foundation.
"For some time, we have recognized and embraced the power of combination strategies for immuno-oncology and this trial will evaluate expanding our lead combination to include Opdivo, the first-in-class anti-PD-1," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "While we continue our efforts to evaluate GVAX Pancreas and CRS-207 in our Phase 2b ECLIPSE trial as an effective treatment for pancreatic cancer, we look forward to generating data in yet another combination for potential future applications of our technologies."
"The Pancreatic Cancer Action Network is thrilled to have provided initial funding that has been leveraged for this important program," said Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network. "In an effort to double pancreatic cancer survival by 2020, we are investing in projects that have the potential to improve the treatment landscape of pancreatic cancer and ultimately increase survival."
"Stand Up To Cancer is excited not only that this immunotherapy clinical trial has begun patient enrollment, one of the 120 clinical trials we have launched or completed," stated SU2C President and CEO Sung Poblete, R.N, Ph.D., "but that it involves collaboration by two distinct biotechnology firms to study the combination of two proprietary immunotherapies. Stand Up To Cancer is proud to have facilitated this level of multi-institutional and corporate collaboration, which is at the core of SU2C’s research model and its mission to benefit cancer patients faster."
Last year, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Aduro’s pancreatic cancer combination treatment consisting of CRS-207 and GVAX Pancreas. According to the FDA, a Breakthrough Therapy designation is for a drug candidate that treats a serious or life-threatening condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies.
Separately, Aduro is currently conducting a 240 patient Phase 2b clinical trial (ECLIPSE; www.clinicaltrials.gov identifier NCT02004262) in metastatic pancreatic cancer patients who have received at least one line of therapy. The randomized, controlled 3-arm trial will involve approximately 20 clinical trial sites in the United States and Canada and will evaluate the safety, immune response and efficacy of the combination immunotherapy of GVAX Pancreas in combination with CRS-207 compared to chemotherapy or to CRS-207 as a monotherapy. The primary endpoint of the trial is overall survival.