HALO Pancreatic 301 is a global Phase 3 clinical research study for patients with untreated Stage IV pancreatic cancer and whose cancer has a high level of a sugar called HA.* All patients who enroll will receive the current FDA-approved standard of care for untreated Stage IV pancreatic cancer, a chemotherapy regimen of Abraxane® and gemcitabine. In addition, 2 out of every 3 patients will also receive the investigational drug being studied, called PEGPH20 (pegvorhyaluronidase alfa). Patients should only enroll after careful discussion with a study doctor.
PEGPH20 is an investigational drug that is being studied to see if it can enhance the ability of Abraxane and gemcitabine to kill cancer cells of HA-HIGH tumors and help patients live longer or slow down the time until their cancer progresses. PEGPH20 has not been approved by the FDA. It is not known if PEGPH20 works or if it is safe.
*HA testing to determine a cancer’s HA status can only be done during the screening process for HALO Pancreatic 301.
HA, which stands for hyaluronan, also called hyaluronic acid, is a sugar that the body naturally makes. It is common throughout the body and plays an important role in the normal function of many tissues, including the skin, joints, and eyes. HA attracts water, and together they form a gel-like substance.
HA can also accumulate or build up in certain tumors. About 35% to 40% of Stage IV pancreatic cancers are “HA-HIGH,” which means they have a high level of HA.1 When HA builds up in a tumor, so does the amount of gel that is formed when HA and water combine. This is associated with an increase in pressure. The increase in pressure is believed to squeeze the blood vessels, causing the blood vessels to compress. This may make it harder for anti-cancer therapies and immune cells to reach and kill cancer cells, because they travel through the blood vessels.
PEGPH20 is an investigational drug, meaning that it is currently not FDA approved for the treatment of pancreatic cancer. It is a special type of protein (called an enzyme) that breaks down HA, and it is believed that it may fight cancer in a new way when given with certain anti-cancer therapies, compared to traditional anti-cancer therapies alone. Halozyme®, the company studying PEGPH20, believes it may enhance the ability of immune cells and certain anti-cancer therapies to reach cancer cells of HA-HIGH tumors by breaking down the HA barrier that builds up in these tumors.
PEGPH20 is being studied to find out if breaking down the HA-HIGH barrier around cancer cells helps anti-cancer therapies and immune cells work better.
PEGPH20 is being studied and is not approved. In a previous study of patients with pancreatic cancer, of the 49 patients with HA-HIGH tumors who received PEGPH20 plus chemotherapy:
There is no guarantee that patients will see a similar result should they enroll in HALO Pancreatic 301 and receive PEGPH20. It is also not known whether or not the impact on tumor size will help patients live longer or have any other benefits.
PEGPH20 is a drug being tested in clinical studies and has not been approved by the FDA. It is not known if PEGPH20 works or if it is safe.Find out if you may be eligible to take part in this study >