TGen-led pilot clinical trial shows tumor shrinkage in 71 percent of patients with late-stage pancreatic cancer
The combination of nab-paclitaxel and gemcitabine as a treatment regimen for pancreatic cancer gained FDA approval in 2013 following extensive testing that demonstrated the combination enabled longer survival for patients with advanced pancreatic cancer.
Following that success, continuing laboratory investigations showed that adding a third ingredient — platinum in the form of a drug called cisplatin — inhibited the ability of pancreatic cancer cells to repair their DNA, causing them to self-destruct. Adding this third drug — coined the TGen Triple — to the previously approved duo of nab-paclitaxel and gemcitabine targeted that molecular vulnerability, providing even more benefit to patients.
Published October 3 in the Journal of the American Medical Association (JAMA) Oncology, researchers found that among a clinical trial of 25 patients, the TGen Triple resulted in substantial tumor shrinkage for 71 percent of those patients, and dramatically increased survival beyond one year.
40 Percent of Patients Survive More Than Two Years
One year after entering the trial, 64 percent were still alive, far greater than the average one-year survival, which is only 26 percent for advanced pancreatic cancer patients. After two years, 40 percent were alive, a survival rate not previously seen for patients with stage IV pancreatic cancer, said TGen Physician-in-Chief, Dr. Daniel Von Hoff, the study’s senior author.
“The results of this triple-drug regimen are very encouraging for these patients,” said Dr. Von Hoff, “Considering the rapid disease response, acceptable safety profile, and encouraging anti-tumor activity, further study of this triple-drug combination and additional tumor molecular analysis is needed to correlate these molecular findings with patient response to treatment.”
In the quest for even greater patient benefit, Dr. Von Hoff and his multi-institutional teams are now studying the TGen Triple in combination with super-enhancer modifying drugs such as entinostat, minnelide, high-dose pharmaceutical vitamin C, ketogenic diet and AXL inhibitors.
Substantial Improvement Seen in First Three Weeks
Because some patients showed substantial improvement in the first three weeks of the TGen Triple pilot clinical trial, this three-drug combination is being considered for early management of pancreatic cancer patients, and also as a
pre-surgical treatment, according to the study.
Nearly two-thirds of patients in the TGen Triple clinical trial completed at least three 21-day, full-dose therapy cycles, said HonorHealth’s Gayle Jameson, N.P., the principal investigator in this clinical trial and one of the study’s co-lead authors. Toxicity levels were minimized by using a relatively low dose of cisplatin and providing patients with aggressive intravenous hydration.
“Many pancreatic tumors possess DNA repair deficiencies and are potentially vulnerable to new targeted therapies. We hypothesized that the addition of a platinum, in this case cisplatin, could improve treatment efficacy and patient outcomes,” said Dr. Erkut Borazanci, a clinical oncology investigator at HonorHealth Research Institute, and clinical associate professor at TGen. Dr. Borazanci also is a co-lead author of the paper.
This TGen Triple is being further studied at the HonorHealth Research Institute. The clinical trial is available to patients with untreated advanced pancreatic cancer. For more information, please go to HonorHealth.com/research or call 480-323-1339.
Contributing to the study — Response rate to albumin-bound paclitaxel plus gemcitabine plus cisplatin treatment among patients with advanced pancreatic cancer: A phase 1b/2 pilot clinical trial — were: University of Arizona Comprehensive Cancer Center, Rutgers Cancer Institute, Vita Medical Associates, Mayo Clinic in Arizona, Imaging Endpoints Research and Core Lab and Cancer Research And Biostatistics, as the operations office and statistics and data management center for the Pancreatic Cancer Research Team.
The research was supported by a SU2C-CRUK-Lustgarten Pancreatic Cancer Dream Team research grant (SU2C-AACR-DT20-16). Additional funding was provided by: Roger E. Magowitz and the Seena Magowitz Foundation, the TGen Foundation, the HonorHealth Foundation and Mattress Firm.