Pancreatic Cancer patient
A global Phase 3 study
THINK
HA FIRST
Before treating newly diagnosed patients with mPDA, think HA
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Doctor treating a Pancreatic Cancer patient
Your first consideration for patients with mPDA starts with HA
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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 >

Hyaluronan (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.

PEGPH20

(pegvorhyaluronidase alfa)

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.

Pancreatic Cancer: PEGYLATED FORM OF RHUPH20 (recombinant human hyaluronidase)

Think HA First

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 >

Phase 2 Data7

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.

  • Median PFS increased by 4 months (9.2 vs. 5.2 months; HR = 0.51)
  • Improvement in overall response rates (ORR) (45% vs. 31%)
  • Median overall survival (OS) of 11.5 vs. 8.5 months

In Stage 2 alone, an analysis of HA-HIGH patients treated with PEGPH20 and AG versus AG showed:

  • 91% increase in median PFS (8.6 months compared to 4.5 months)
  • 50% increase in median OS (11.7 months compared to 7.8 months)

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.

Phase 2 (Stage 1 + Stage 2) Secondary Endpoint:
PFS in HA-HIGH Patients

Phase 2: Increased PFS in HA-HIGH Patients

Primary Safety Endpoint:
TE Rate (Stages 1 and 2)

Phase 2 (Stage 2): Primary Safety Endpoint Achieved * TE event rates for all Stage 2 patients are 14% (12/86) in PAG arm and 10% (4/39) in AG arm



Phase 3 Study Design

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.

Pancreatic Cancer: PEGPH20 Dosing Schedule

PEGPH20 Dosing Schedule

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.

HA Testing

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.

Key Inclusion Criteria*

  • 18 years old and over
  • Confirmed Stage IV pancreatic ductal adenocarcinoma, with confirmed HA-HIGH tumor status
  • No radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease
  • No known central nervous system involvement, such as brain metastasis

* 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.

HALO Pancreatic 301 study Sites

HALO Pancreatic 301 is a global study and will have nearly 200 study sites in 20 countries. Check back often for the full site list.

If you are interested in referring a patient, please call 1-877-396-3682.

State City Study Site
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
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 San Francisco UCSF Helen Diller Family Comprehensive Cancer 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
CT Stamford Stamford Hospital - Carl and Dorothy Bennett Cancer Center
DC Washington MedStar Georgetown University Hospital
FL Jacksonville 21st Century Oncology
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 Clifton Saint Joseph’s Ambulatory Clinic
NJ Ridgewood Valley Health System - The Valley Hospital (TVH)
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 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 Madison University of Wisconsin Health - UW Carbone Cancer Center
WI Milwaukee Columbia St. Marys
WI Milwaukee Medical College of Wisconsin
References
1. Halozyme. Data on file.
2. Whatcott CJ, Diep CH, Jiang P, et al. Desmoplasia in primary tumors and metastatic lesions of pancreatic cancer. Clin Cancer Res. 2015;21(15):3561-8.
3. Brekken C, Bruland ØS, de Lange Davies C. Interstitial fluid pressure in human osteosarcoma xenografts: significance of implantation site and the response to intratumoral injection of hyaluronidase. Anticancer Res. 2000; 20(5B):3503-12.
4. Provenzano PP, Hingorani SR. Hyaluronan, fluid pressure, and stromal resistance in pancreas cancer. Br J Cancer. 2013;108(1):1-8.
5. Thompson CB, Shepard HM, O'Connor PM, et al. Enzymatic depletion of tumor hyaluronan induces antitumor responses in preclinical animal models. Mol Cancer Ther. 2010; 9(11):3052-64.
6. Stylianopoulos T, Jain RK. Combining two strategies to improve perfusion and drug delivery in solid tumors. Proc Natl Acad Sci U S A. 2013; 110(46):18632–7.
7. Hingorani SR, Bullock A, Seery T, et al. Randomized Phase 2 Study of PEGPH20 Plus nab-Paclitaxel / Gemcitabine (PAG) vs nab-Paclitaxel / Gemcitabine (AG) in Patients with Untreated, Metastatic Pancreatic Ductal Adenocarcinoma. Presented at 2017 American Society of Clinical Oncology Annual Meeting; June 2-6, 2017; Chicago, IL, USA.

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