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 (pegvorhyaluronidase alfa), 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 HA accumulation serves as an indicator for poor survival in pancreatic and other cancers.2 Because HA readily attracts water molecules, HA accumulation is associated with increased tumor pressure3,4 and constriction of tumor vasculature,5,6 which may reduce access 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 indicator for poor 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 combined analysis of patients treated in both Stages 1 and 2 of the Phase 2 study showed a significant increase in progression-free survival (PFS) in patients whose tumors were HA-HIGH and treated with PEGPH20 and AG (PAG) (n = 49) versus AG alone (n = 35). This analysis also met the key study objectives, showing improved PFS for total patients in the PAG arm, as well as HA-HIGH patients in the PAG arm.
In Stage 2 alone, an analysis of HA-HIGH patients treated with PEGPH20 and AG versus AG showed:
Analysis of the Stage 2 data also met the study’s primary safety endpoint, a reduction in thromboembolic events, achieved with protocol modifications and low-molecular-weight heparin prophylaxis.
This final data analysis utilized the HA assay created in collaboration with Ventana Medical Systems and was based on an HA cut point of ≥ 50%, which is the Phase 3 HA-testing methodology. The results of the combined data analysis are supportive of the Phase 3 study assumptions in HA-HIGH patients. The Phase 3 HALO Pancreatic 301 study is designed to provide conclusive evidence of the efficacy and safety of PEGPH20.
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|
|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 – Cedars-Sinai|
|CA||Orange||Chao Family Comprehensive Cancer Center|
|CA||Orange||St. Joseph Hospital|
|CA||Rancho Mirage||Desert Hematology Oncology Medical Group, Inc.|
|CA||Redondo Beach||Cancer Care Associates Medical Group, Inc.|
|CA||San Francisco||Pacific Hematology Oncology Associates|
|CA||San Francisco||UCSF Helen Diller Family Comprehensive Cancer Center|
|CA||San Luis Obispo||Pacific Central Coast Health Centers: San Luis Obispo and Hematology Health Center|
|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|
|CO||Grand Junction||St. Mary's Medical Center|
|CT||New Haven||Yale Cancer Center|
|CT||Stamford||Stamford Hospital - Carl and Dorothy Bennett Cancer Center|
|DC||Washington||MedStar Georgetown University Hospital|
|FL||Hollywood||Memorial Healthcare System - Memorial Cancer Institute|
|FL||Jacksonville||21st Century Oncology|
|FL||Orlando||University of Florida (Orlando Cancer Center)|
|IN||Fort Wayne||Fort Wayne Medical Oncology/Hematology|
|KS||Fairway||The University of Kansas Cancer Center|
|LA||Baton Rouge||Ochsner Health Center|
|LA||New Orleans||Ochsner Clinic CCOP|
|MA||Boston||Beth Israel Deaconess Medical Center|
|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|
|NC||Raleigh||Rex Cancer Center - Rex Hematology Oncology Associates|
|NJ||Neptune||Jersey Shore University Medical Center|
|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||Abington||Abington Hospital Rosenfeld Cancer Center|
|PA||Pittsburgh||Allegheny General Hospital|
|PA||Pittsburgh||University of Pittsburgh Cancer Institute|
|TX||Houston||Baylor College of Medicine - Baylor Clinic|
|TX||Temple||Scott and White|
|UT||Salt Lake City||University of Utah - Huntsman Cancer Institute|
|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||Milwaukee||Columbia St. Marys|
|WI||Milwaukee||Medical College of Wisconsin|