HALO Pancreatic 301 (HALO-109-301) is a Phase 3 clinical study that provides patients with previously untreated Stage IV (metastatic) pancreatic ductal adenocarcinoma (mPDA) whose tumors are high in hyaluronan (HA-HIGH) with the opportunity to potentially receive PEGPH20, an investigational drug that targets HA. The goal of this study is to evaluate the effects of PEGPH20. PEGPH20 degrades HA within the tumor microenvironment and is thought to increase anti-cancer therapeutic access to the tumor. PEGPH20 is given in combination with an approved first-line chemotherapy regimen for mPDA (Abraxane® and gemcitabine, or AG), which is administered to all study participants regardless of treatment arm. FIND OUT WHY TREATING mPDA STARTS WITH HA >
HA is a glycosaminoglycan polymer of repeating disaccharides that accumulates within the tumor microenvironment of many solid tumors, and high levels have been found in an estimated 35%-40% of metastatic pancreatic cancer in one Phase 2 study.1 The extent of HA accumulation is a strong, independent, negative predictor of overall survival.2 Because HA readily attracts water molecules, HA accumulation is associated with increased tumor pressure3,4 and compression-narrowed blood vessels,5,6 which may reduce delivery of anti-cancer therapeutics to the tumor.
The investigational drug PEGPH20 is a potentially novel approach to cancer treatment that targets the accumulation of HA within the tumor microenvironment. By targeting HA for degradation, PEGPH20 is believed to enhance the efficacy of certain anti-cancer therapeutics by increasing access to the HA-HIGH tumor. In animal models, HA degradation with PEGPH20 led to reduced tumor pressure, improved vascular perfusion, and increased access of anti-cancer therapeutics.
Because HA is a known negative predictor of patient survival in pancreatic cancer,2 it is being investigated in the HALO Pancreatic 301 study as a potential biomarker that may prove helpful in guiding treatment decisions for mPDA patients. PEGPH20, the investigational drug being studied, targets HA, which makes HALO Pancreatic 301 a potentially important first consideration for patients who have untreated HA-HIGH mPDA.See the Phase 2 data >
Results from a final analysis of patients treated in Stage One of the Phase 2 study showed higher progression-free survival (PFS) and response rates in patients whose tumors were HA-HIGH and treated with PEGPH20 and AG (PAG) (n = 22) versus AG alone (n = 21).7
This analysis of the Phase 2 data utilized the planned Phase 3 HA-testing methodology created in collaboration with Ventana Medical Systems and is supportive of the Phase 3 study assumptions. The Phase 3 HALO Pancreatic 301 study is designed to provide conclusive evidence of the efficacy and safety of PEGPH20.
In Stage 2 of the Phase 2 study, primary endpoints were achieved. Updated data will be presented at a future congress.
PEGPH20 is an investigational drug and has not been approved by the US Food and Drug Administration (FDA). The safety and efficacy of PEGPH20 have not been established.
HALO Pancreatic 301 is a Phase 3, randomized, double-blind, placebo-controlled multicenter study. Patients will be randomized in a 2:1 ratio (PAG:AG). To reduce the potential risk of a blood clot or thromboembolic event, low-molecular-weight heparin prophylaxis is required for all patients who enroll in the study.
In the HALO Pancreatic 301 study, PEGPH20 has a fast infusion time (typically 10-12 minutes) and the treatment schedule is the same as for Abraxane® and gemcitabine after the first cycle.
PEGPH20 is being developed with a companion diagnostic in partnership with Ventana Medical Systems. This diagnostic will be utilized to determine if a tumor is HA-HIGH or HA-LOW, and it is only available to screen patients for HALO Pancreatic 301. To test for HA, a large enough tissue sample from the tumor is required, typically achieved by performing a core biopsy. Fine needle aspiration does not procure enough tissue for HA testing.
If a core biopsy is collected at the time of initial tumor sampling by a referring physician, it is possible that the patient will not need to undergo an additional biopsy to determine tumor status as part of the HALO Pancreatic 301 screening process. The initial core biopsy typically provides a sufficient amount of tissue for HA testing.
* These are not the only criteria required for enrollment in HALO Pancreatic 301. Eligibility will be determined during the study screening process.
† HA testing will be conducted during the screening period.
|AL||Mobile||University of South Alabama|
|AR||Fayetteville||Highlands Oncology Group|
|AZ||Gilbert||Banner MD Anderson Cancer Center|
|AZ||Scottsdale||HonorHealth Research Institute|
|CA||Fullerton||St. Jude Medical Center - St. Joseph Heritage Health|
|CA||La Jolla||Scripps Clinical Research Services|
|CA||Long Beach||Long Beach Memorial Medical Center|
|CA||Los Angeles||David Geffen School of Medicine (DGSOM) at UCLA|
|CA||Los Angeles||Samuel Oschin Comprehensive Cancer Institute|
|CA||Orange||Chao Family Comprehensive Cancer Center|
|CA||Orange||St. Joseph Hospital|
|CA||Rancho Mirage||Desert Hematology Oncology Medical Group, Inc.|
|CA||San Francisco||Pacific Hematology Oncology Associates|
|CA||Santa Rosa||St Joseph Heritage Healthcare|
|CA||Whittier||Innovative Clinical Research Institution|
|CO||Denver||Kaiser Permanente Franklin Medical Offices|
|CO||Denver||US Oncology - Rocky Mountain Cancer Centers - Midtown|
|CT||Stamford||Stamford Hospital - Carl and Dorothy Bennett Cancer Center|
|DC||Washington||MedStar Georgetown University Hospital|
|FL||Jacksonville||21st Century Oncology|
|LA||New Orleans||Ochsner Clinic CCOP|
|MA||Boston||Beth Israel Deaconess Medical Center|
|MA||Boston||Dana Farber Cancer Institute|
|MA||Worcester||UMass Memorial Medical Center|
|MD||Baltimore||The Sidney Kimmel Comprehensive Cancer Center|
|MI||Ann Arbor||University of Michigan Medical Center|
|MI||Detroit||Karmanos Cancer Institute|
|MN||Minneapolis||Virginia Piper Cancer Institute|
|MN||Minneapolis||University of Minnesota Medical School|
|NJ||Clifton||Saint Joseph’s Ambulatory Clinic|
|NJ||Ridgewood||Valley Health System - The Valley Hospital (TVH)|
|NV||Las Vegas||Comprehensive Cancer Centers of Nevada|
|NY||Lake Success||Northwell Health/Monter Cancer Center|
|NY||New Hyde Park||NYU Langone Medical Center - NYU Langone Arena Oncology|
|NY||New York||Mount Sinai School of Medicine - The Tisch Cancer Institute|
|NY||New York||Columbia University Medical Center|
|NY||Rochester||University of Rochester Medical Center|
|OH||Canton||Gabrail Cancer Center Research|
|OK||Oklahoma City||The University of Oklahoma Health Sciences Center|
|PA||Hershey||Penn State Milton S. Hershey Medical Center|
|PA||Pittsburgh||Allegheny General Hospital|
|PA||Pittsburgh||University of Pittsburgh Cancer Institute|
|TX||Houston||Baylor College of Medicine - Baylor Clinic|
|VA||Fairfax||Inova Dwight and Martha Schar Cancer Institute|
|VA||Fort Belvoir||Fort Belvoir Community Hospital|
|VA||Mechanicsville||Virginia Cancer Institute|
|WA||Seattle||Swedish Cancer Institute/ Swedish Health Services|
|WA||Seattle||University of Washington (UW) - Seattle Cancer Care Alliance|
|WA||Tacoma||Northwest Medical Specialties PLLC|
|WI||Madison||University of Wisconsin Health - UW Carbone Cancer Center|
|WI||Milwaukee||Columbia St. Marys|
|WI||Milwaukee||Medical College of Wisconsin|