Why This Trial About the Study Results Where We're At Now Locations Researchers Partners Why This Trial Pancreatic cancer is notoriously ruthless. It strikes almost 60,000 people in the United States every year and is now the third leading cause of cancer-related deaths in the nation. Only 8.5% of patients survive five years after diagnosis. Pancreatic ductal adenocarcinoma (PDAC) is the most common form. Earlier clinical trials with immunotherapy alone failed against this type of cancer. However, research by PICI investigator Robert Vonderheide, MD, DPhil, of the University of Pennsylvania suggested that combining immunotherapy and chemotherapy showed promise for defeating this disease. About the Study We tackle pancreatic cancer from different angles in this trial, now in phase 2. In addition to standard-of-care chemotherapy, we attack the tumor with two different immunotherapy agents. One is an experimental antibody that targets the CD40 protein and propels the immune system into action. The second is a PD-1 checkpoint inhibitor that takes the brakes off the immune system so it can fight cancer more effectively. Who’s Eligible The trial is open to patients with untreated metastatic pancreatic ductal adenocarcinoma. Treatments Tested APX005M Nivolumab Gemcitabine and nab-paclitaxel Results Promising interim phase 1b findings were presented at the 2019 American Association for Cancer Research annual meeting. Phase 1b safety and biomarker analysis was published in The Lancet Oncology in January 2021. The novel treatment combination shrank pancreatic tumors in more than half of evaluable patients. More than two thirds of patients remained on treatment for a year or more, indicating that the combination was capable of inducing long-lasting responses; whereas, the life expectancy of patients treated with chemotherapy alone is less than one year. This is the first demonstration that immunotherapy can have a positive effect in pancreatic cancer. Where We’re At Now The first patients underwent treatment in August 2017 at the University of Pennsylvania. After a successful phase 1b trial, we completed enrollment for phase 2 in June 2019. We expect to have clinical and translational topline results for Phase 2 in 2021. Based on data from this trial, a platform study is in design to test science-driven novel combinations. Locations The University of Pennsylvania (lead site) Dana-Farber Cancer Institute Memorial Sloan Kettering Cancer Center Stanford Medicine University of California, Los Angeles University of California, San Francisco The University of Texas MD Anderson Cancer Center Please note the trial is no longer enrolling patients. Researchers Lead Robert Vonderheide, MD, DPhil | University of Pennsylvania Site Investigators George Fisher, MD | Stanford Medicine Andrew Ko, MD | University of California, San Francisco Mark O’Hara, MD | University of Pennsylvania Eileen O’Reilly, MD | Memorial Sloan Kettering Cancer Center Gauri Varadhachary, MD | The University of Texas MD Anderson Cancer Center Zev Wainberg, MD | University of California, Los Angeles Partners Leveraging our collaborative model, we engaged partners in academia, biotech, pharma and nonprofit to make the trial a reality, going from concept to launch in less than six months. Apexigen Bristol Myers Squibb Cancer Research Institute PICI holds the Investigational New Drug application from the U.S. Federal Drug Administration. For more information on this trial (NCT03214250), visit www.clinicaltrials.gov. Related Our Impact, Patient Story A Legacy of Service and a New Day for Pancreatic Cancer Our Impact, Research Update Tackling Pancreatic Cancer with a Triple Threat Our Impact, Press Release, Research Update For Advanced Pancreatic Cancer, Combining Immunotherapies with Chemotherapy Shows Early Promise in Reducing Tumor Size Partner Highlight Nonprofits Join Forces for a Cure Partner Highlight A Win-Win in Cancer Research: Bristol-Myers Squibb
Our Impact, Press Release, Research Update For Advanced Pancreatic Cancer, Combining Immunotherapies with Chemotherapy Shows Early Promise in Reducing Tumor Size