These statistically significant and clinically meaningful improvements in overall response and survival rates resulted from a phase Ib/II clinical study performed at the HonorHealth Research Institute, a partnership of HonorHealth and TGen.
The results were presented during the 2017 Gastrointestinal Cancers Symposium, sponsored by the American Society of Clinical Oncology, in San Francisco. Connecting a global network of more than 40,000 cancer professionals, the society serves as the leading resource for best practices in clinical oncology research and academic and community practices.
“After just three treatment cycles, we saw tumor markers plummet and some patients’ tumors shrink significantly in just nine weeks,” said Gayle Jameson, nurse practitioner and principal investigator of the clinical trial, who is highly encouraged by the response. “After treatment, two patients had no evidence of disease and are alive over three years after starting this regimen. This is very rare with traditional chemotherapy.”
Dr. Daniel Von Hoff, TGen Distinguished Professor and Physician-in-Chief who devised the clinical trial, agreed: “Although a small study, the high response rate and landmark evolving median survival are very encouraging, and this regimen is being expanded for patients with stage IV pancreatic cancer.” Dr. Von Hoff also is chief scientific officer at the HonorHealth Research Institute.
Of the 24 evaluable patients (those whose response to a treatment could be measured because enough information was collected) who were enrolled in the study:
- Eleven patients are still alive. The median overall survival rate of 16.5 months exceeds the historical average survival of six-12 months with standard chemotherapy.
- Seventeen of 24 patients — 71 percent — had a reduction in tumor size of at least 30 percent.
- Two of those 17 patients had a complete response — no detectable tumor.
This pilot clinical trial began in 2013 through a partnership between the HonorHealth Research Institute and TGen. It was funded by Stand Up To Cancer, Mattress Firm, the Arizona Diamondbacks, and the Scottsdale-based Seena Magowitz Foundation.
Symptoms of pancreatic cancer usually do not appear until the disease progresses to its late stages, making it difficult to treat. Only about one in four patients survives more than a year after diagnosis, and fewer than 10 percent survive more than five years. Pancreatic cancer this year will take the lives of more than 43,000 Americans, making it the nation’s third-leading cause of cancer-related death.
The results of this trial are encouraging and deserve additional testing prior to becoming a standard of care for patients with advanced pancreatic cancer. Through research, the HonorHealth Research Institute and TGen aim to provide hope and a better chance for patients to live for years instead of months.
The current standard of care for advanced pancreatic cancer — a combination of nab-paclitaxel and gemcitabine — was developed by TGen and the HonorHealth Research Institute, and approved by the U.S. Food and Drug Administration in 2013.