Immunotherapy COMBAT Clinical Trial

Immunotherapy COMBAT Clinical Trial

HonorHealth and TGen Investigators Encouraged With Results and Hope To Show Patient Benefit in Larger Studies

Based Upon TGen Press Release
Edited For Style and Presentation
August 22, 2020

Working with an international team of researchers, HonorHealth Research Institute in Scottsdale, Arizona and the Translational Genomics Research Institute (TGen), in Phoenix, Arizona, were instrumental in one of the first clinical trials showing how pancreatic cancer patients can benefit from immunotherapy, according to a four-year study published in a premier scientific journal, Nature Medicine.

The “COMBAT trial” (NCT02826486) is a prospective, open label, phase IIa clinical trial for patients with metastatic pancreatic cancer, meaning their cancer had spread to distant parts of the body. Patients were given pembrolizumab (Keytruda) from Merck, an immune therapy drug, in combination with BL-8040, an agent that makes the tumor microenvironment more receptive to immune therapy.

The study was conducted in Arizona at the HonorHealth Research Institute and at 30 other locations in the U.S. and across the globe, including Spain, Israel and South Korea.

The Two-Part Clinical Trial Began in September 2016

• Cohort 1, a group of 37 patients whose cancer had already progressed on other therapies,were treated with pembrolizumab and BL-8040. Importantly, it appeared this combination therapy made pancreatic cancer more “hot,” meaning it could work in-tandem with the body’s own immune system. Previous studies have shown pancreatic tumors to be “cold,” meaning immune therapies like pembrolizumab were not able to act on the cancer.

• Preliminary results of Cohort 2 were reported in the manuscript on a group of 22 patients (out of approximately 40 patients in total expected in the cohort), who had previously received one line of chemotherapy. These patients received pembrolizumab and BL-8040, as well as chemotherapy drugs 5-fluorouracil and nano-liposomal irinotecan.

“The percentage of meaningful tumor shrinkage was 32% in Cohort 2, which is double what is available for individuals with pancreatic cancer with traditional chemotherapy. While the study is small, these preliminary results are encouraging and there is hope that we will be able to do larger trials to see if the response to therapy is high and if it is better in comparison to traditional treatment,” said Erkut Borazanci, M.D., M.S., a medical oncologist and physician-investigator at HonorHealth Research Institute, a clinical associate professor at TGen, and one of the paper’s authors.

This Clinical Trial is Currently in A Follow-Up Phase of The Study

Pancreatic cancer is an aggressive disease that carries a high mortality rate. It is the third-leading cause of cancer death in the U.S., following lung and colorectal cancers. In 2020, the five-year survival rate for pancreatic cancer is 10%, which has increased from 6% in 2014.

Next steps for this research would be to compare this COMBAT combination therapy in future studies to other treatment options, such 5-fluorouracil, leucovorin and nano-liposomal irinotecan.

COMBAT derives its name from letters in one of the study’s descriptions: Combination of BL-8040 and Pembrolizumab in Patients with Metastatic Pancreatic Cancer.

The COMBAT treatment continues at the HonorHealth Research Institute. For more information, please go to https://www.honorhealth.com/company/research-institute, call 480-323-1339 or email clinicaltrials@honorhealth.com.

This research is supported by BioLineRx Ltd.

The study – BL-8040, a CXCR4 antagonist, in combination with pembrolizumab and chemotherapy for pancreatic cancer: the COMBAT trial – was published May 25, 2020, in Nature Medicine.

About HonorHealth Research Institute

HonorHealth Research Institute in Scottsdale, Arizona is helping shape the future of medicine. We’re finding cures and improving treatments in areas like gene therapy, early drug/device development, early detection and prevention of disease. Through our clinical trials and applied research, we’ve given hope and improved the lives of patients from all 50 states and 28 different countries around the globe. Our advanced technologies and cutting-edge treatment options are introducing tomorrow’s cures, today. For more information on oncology clinical trials for pancreatic cancer email clinicaltrials@honorhealth.com or learn more at HonorHealth.com/research.

About TGen, An Affiliate of City of Hope

Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life-changing results. TGen is affiliated with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases: www.cityofhope.org. This precision medicine affiliation enables both institutes to complement each other in research and patient care, with City of Hope providing a significant clinical setting to advance scientific discoveries made by TGen. TGen is focused on helping patients with neurological disorders, cancer, diabetes and infectious diseases through cutting-edge translational research (the process of rapidly moving research toward patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and complex rare diseases in adults and children. Working with collaborators in the scientific and medical communities worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.

Read More About The COMBAT Clinical Trial Qualifications

Seena Magowitz Foundation For Pancreatic Cancer