Ten Years after its founding, the Pancreatic Cancer Research Team (PCRT) is announcing the positive results of a large Phase III clinical trial involving more than 800 patients. PCRT is celebrating its 10th anniversary of accelerating new and effective medicines to patients with pancreatic cancer.
Pancreatic cancer is the fourth leading cause of death in the U.S., and it is still one of the most difficult cancers to identify, diagnose early, and treat effectively. Daniel Von Hoff, M.D., F.A.C.P., Physician in Chief and Distinguished Professor at Translational Genomics Research Institute (TGen), and 11 clinical investigators from around the world founded the PCRT in 2003 with the goal of becoming the international driving force for pancreatic cancer research and new medicine development. Today the PCRT, a division of Translational Drug Development, Inc. (TD2) in Scottsdale Arizona, consists of 45 institutions, and 75 investigators from the U.S. and Western Europe and represents the world’s only program dedicated to rapidly translating research discoveries into new treatments and supportive care for patients with pancreatic cancer.
Results from a large Phase III clinical trial sponsored by Celgene Corporation will be presented by Dr. Von Hoff this week at the 2013 American Society of Clinical Oncology (ASCO) Annual meeting. The MPACT trial (Metastatic Pancreatic Adenocarcinoma Clinical Trial) tested the novel combination of two already approved medicines — Abraxane® and Gemzar® — in more than 800 patients with pancreatic cancer. PCRT founder Dr. Von Hoff was the International Principal Investigator, for the MPACT trial and Dr. Ramesh Ramanathan, the current PCRT Chairman, was the U.S. National Principal Investigator. The PCRT consortium contributed more than half of the PCRT Member Institutions—25 sites—to this global trial. The results showed an increase in overall survival for patients with advanced pancreatic cancer from 6.7 months to 8.5 months, and an increase in the one-year survival by 59%, and an increase in the 18-month survival by 78%
In 2011, The PCRT European Members were involved in a large Phase III trial in France of another front-line treatment for advanced pancreatic cancer patients using a combination of four drugs called FOLFIRINOX (5-Fluoruoricil, Leucovorin, Oxaliplatin, and Irinotecan) compared to Gemzar. The FOLFIRINOX regimen showed an increase in overall survival by 63% (11.1 months on FOLFIRINOX vs. 6.8 months on Gemzar), and an increase in one-year survival of 48.4% with FOLFIRINOX compared to 20.2% with Gemzar alone.
According to Dr. Daniel Von Hoff, “Because of the hard work of PCRT consortium testing new medicines and drug combinations over the past 10 years, the advancement of these new treatments has the potential to have a measurable impact on extending survival for metastatic pancreatic cancer patients.” He added, “We are grateful for the philanthropy and support that we have received over these years to help put together these talented investigators to make significant advances against this disease”.
Over the past 10 years, The PCRT has conducted more than 30 clinical trials using a variety of new treatments for patients with pancreatic cancer. “The PCRT is a unique multi-disciplinary consortium of highly experienced, nationally known clinical and translational investigators who have come together to make a difference for patients with pancreatic cancer.” said Dr. Ramesh Ramanathan, current Chairman of PCRT. “We know we don’t have the luxury of time, we need to make advances in the laboratory available to patients as soon as possible, and our goal is to do rapid pilot studies and identify new agents and strategies which can be taken forward into the clinic.” One such study is an ongoing trial that Dr. Ramanathan is presenting this week at the 2013 ASCO Annual Meeting exploring Gemzar plus Abraxane for patients in the neoadjuvant setting. Preliminary results show that patients’ tumors are smaller using this combination treatment before surgery.
Because the PCRT has accelerated the rate at which studies can be completed, pharmaceutical companies rely on PCRT for testing their new drugs. “Since 2006, Celgene’s collaboration with PCRT has enabled robust clinical trial design and accelerated recruitment into important trials that have advanced innovative new treatments for patients with pancreatic cancer” said Markus Renschler, MD, Corporate Vice President, Global Head of Hematology & Oncology Medical Affairs at Celgene. “Pancreatic cancer remains one of the hardest cancers to treat with little hope for a cure. Celgene remains committed to our work with PCRT to continue to advance the science of pancreatic cancer treatment and to improve patient outcomes through rapid clinical testing of promising new agents.”
The next 10 years hold great promise for PCRT and for patients with pancreatic cancer. “The application of more predictive preclinical screening models like those used at TD2, will identify unique contexts of sensitivity for new medicines in specific patients with pancreatic cancer” said Stephen Gately, Ph.D., President and CEO for TD2. “This precision approach to drug development will enrich clinical trials with patients most likely to have clinical benefit”.
The PCRT continually uses the results of current studies such as imaging techniques, biomarker identification, and extensive genetic analysis of tumor samples to pinpoint the exact treatment that will be the most effective for each patient. Because of the vast experience in all realms of clinical practice, including clinical oncology, surgery, radiology, and lab experience in new genomic techniques, the PCRT has the unique ability to immediately use new information from both clinical and non-clinical research to design each clinical trial in real-time to respond to the rapidly changing information that is discovered about pancreatic cancer. “Our goal is simple-” states Dr. Von Hoff, “-to prevent and cure this disease which takes too many of our citizens.”