Drugs / PEGPH20
PEGPH20
English name null
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | pancreatic ductal adenocarcinoma | 2014-04-08 | “the United States Food and Drug Administration (FDA) informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing of PEGPH20” halozyme.com ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03481920 | Jan 2018 → Jan 2019 | pancreatic ductal adenocarcinoma | PH Research, S.L. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 15 trials | ||||||
| Phase 1 | NCT03267940 | Oct 2017 → Nov 2019 | gallbladder adenocarcinoma, intrahepatic cholangiocarcinoma | Halozyme Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02563548 | Oct 2015 → Mar 2019 | gastric adenocarcinoma, non-small cell lung carcinoma | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02346370 | Feb 2015 → Aug 2016 | non-small cell lung carcinoma | Halozyme Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT01170897 | Jul 2010 → Oct 2013 | neoplasm | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00834704 | Feb 2009 → Jun 2012 | cancer | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 1/23 trials · 2 missed | ||||||
| Phase 1/2 | NCT03193190 | Jul 2017 → Feb 2025 | pancreatic adenocarcinoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT01959139 | Jan 2014 → Apr 2019 | pancreatic adenocarcinoma | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 1/2 | NCT01453153 | Sep 2011 → Feb 2014 | pancreas disorder | Halozyme Therapeutics | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT04134468 | Jan 2020 → Feb 2021 | pancreatic ductal adenocarcinoma | Abramson Cancer Center at Penn Medicine | Withdrawn | No outcome recorded |
| Phase 2 | NCT04045730 | Nov → Dec 2019 | pancreatic adenocarcinoma | Yale University | Withdrawn | No outcome recorded |
| Phase 2 | NCT03979066 | Nov 2019 | pancreatic ductal adenocarcinoma | Gulam Manji | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03634332 | May 2019 → Oct 2020 | pancreatic ductal adenocarcinoma | Pancreatic Cancer Research Team | Unknown | No outcome recorded |
| Phase 2 | NCT02487277 | Jul 2015 → May 2018 | pancreatic adenocarcinoma | Andrew Ko | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01839487 | May 2013 → May 2018 | pancreatic ductal adenocarcinoma | Halozyme Therapeutics | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT02715804 | Mar 2016 → Nov 2019 | pancreatic ductal adenocarcinoma | Halozyme Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase not applicable2 trials | ||||||
| — | NCT02921022 | Oct 2016 → Oct 2026 expected | pancreatic ductal adenocarcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| — | NCT02241187 | Sep 2014 → Sep 2016 | pancreatic adenocarcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 38
| Date | Issuer | Release |
|---|---|---|
| 2020-06-22 | Verastem, Inc. | Results Verastem Oncology Announces Presentation of Preclinical Data Supporting the Combination of VS-6766 and Defactinib in Metastatic Uveal Melanoma verastem.com ↗
PEGylated recombinant human hyaluronidase, PEGPH20, significantly enhances the anti-tumor activity of the combination of focal adhesion kinase Inhibitor and anti-PD-1 antibody by targeting CXCR4-expressing myeloid cells in a murine model of PDAC |
| 2019-11-04 | Halozyme Therapeutics | Results Halozyme Announces HALO-301 Phase 3 Study Fails To Meet Primary Endpoint halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the HALO-301 Phase 3 clinical study evaluating investigational new drug PEGPH20 as a first-line therapy for treatment of patients with metastatic pancreas cancer failed to reach the primary endpoint of overall survival. |
| 2018-11-26 | Halozyme Therapeutics | Regulatory Halozyme Announces Change In Primary Endpoint For HALO-301 To Overall Survival halozyme.com ↗
today announced that prior to data analysis, the FDA has agreed to Halozyme's request to change the primary endpoint of the HALO-301 study to the single primary endpoint of overall survival (OS). |
| 2018-10-22 | Halozyme Therapeutics | Results Halozyme Provides Summary Results Of Data For PEGPH20 Combination Treatments Presented At ESMO 2018 Congress halozyme.com ↗
Median PFS is 7.0 months across both cohorts, and median overall survival has not been reached. |
| 2018-10-04 | Halozyme Therapeutics | Results Halozyme Publication In The Journal Clinical Cancer Research Highlights New Nonclinical Data Supporting Multiple Effects Of PEGPH20 On The Tumor Microenvironment halozyme.com ↗
Treatment with PEGPH20 at the human equivalent dose degraded HA in the TME reversing these changes, and also depleted an important proangiogenic growth factor, VEGF-A165, suggesting that treatment with PEGPH20 may diminish the angiogenic potential of the TME. |
| 2018-06-01 | Halozyme Therapeutics | Results Halozyme Identifies Plasma Biomarkers As Potential Predictors Of Survival In Pancreatic Cancer halozyme.com ↗
The exploratory plasma biomarker data may support efforts to identify patients who benefit from our investigational drug, PEGPH20, through a simple blood draw rather than a needle biopsy. |
| 2018-03-14 | Halozyme Therapeutics | Results Halozyme To Present Data From Six Nonclinical Studies At American Association Of Cancer Research Annual Conference halozyme.com ↗
The data presented demonstrate that the presence of hyaluronan can create an immunosuppressive tumor microenvironment and that PEGPH20 increases immune cell infiltration and tumor growth inhibition when used in combination with immunotherapy in hyaluronan-rich tumor animal models. |
| 2017-11-10 | Halozyme Therapeutics | Results Halozyme To Present Nonclinical Data At SITC 2017 Supporting Combination Of PEGPH20 With Checkpoint Inhibitors halozyme.com ↗
The study shows that degradation of hyaluronan (HA) in a tumor by PEGPH20 can facilitate an anti-tumor immune response induced by checkpoint blockade by promoting effector cell infiltration and skewing the immune microenvironment toward a more anti-tumor composition. |
| 2017-06-28 | Halozyme Therapeutics | Results Halozyme Phase 2 Data In Advanced Pancreas Cancer Presented At European Society For Medical Oncology Symposium halozyme.com ↗
PEGPH20 plus standard chemotherapy of ABRAXANE® (nab-paclitaxel) and gemcitabine improved median PFS by 77 percent over chemotherapy alone in HA-High patients. |
| 2017-06-04 | Halozyme Therapeutics | Results Halozyme Phase 2 Data In Advanced Pancreas Cancer Featured In An Oral Presentation At ASCO halozyme.com ↗
PEGPH20 plus standard chemotherapy of ABRAXANE and gemcitabine improved median PFS by 77 percent over chemotherapy alone in HA-High patients. |
| 2017-05-17 | Halozyme Therapeutics | Results Halozyme Phase 2 Data In Advanced Pancreas Cancer To Be Featured In An Oral Presentation At ASCO halozyme.com ↗
The study demonstrated that PEGPH20 plus standard chemotherapy of ABRAXANE® (nab-paclitaxel) and gemcitabine improved median progression-free survival (mPFS) by 77 percent over chemotherapy alone in stage IV pancreas cancer patients with high levels of hyaluronan (HA-High). |
| 2017-04-03 | Halozyme Therapeutics | Results Halozyme's PEGPH20 Increases Immune Response and Effectiveness of Immunotherapies in Preclinical Cancer Models halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, demonstrated in preclinical models that its investigational drug PEGPH20 increases the number of cancer-fighting white blood cells accumulating in the tumor and the effectiveness of immunotherapies. |
| 2017-03-30 | Halozyme Therapeutics | Results Halozyme Provides Update On SWOG Collaborative Group Clinical Study halozyme.com ↗
the SWOG Phase 1b/2 trial evaluating PEGPH20 plus modified FOLFIRINOX chemotherapy versus modified FOLFIRINOX alone in patients with previously untreated metastatic pancreas cancer has been temporarily closed to enrollment. |
| 2017-01-05 | Halozyme Therapeutics | Results Halozyme Announces Phase 2 Study In Advanced Pancreas Cancer Meets Key Endpoints halozyme.com ↗
Among the findings, the overall study population showed a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving ABRAXANE and gemcitabine alone. |
| 2016-06-04 | Halozyme Therapeutics | Results Halozyme Presents Stage One Efficacy And Safety Analysis Of Phase 2 Clinical Study In Metastatic Pancreatic Cancer Patients Treated With PEGPH20 halozyme.com ↗
today announced results from a final analysis of 135 metastatic pancreatic cancer patients who were treated in Stage One of HALO 109-202, a phase 2 clinical study of its investigational new drug PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine (PAG arm) as compared to ABRAXANE and gemcitabine alone (AG arm). |
| 2016-04-18 | Halozyme Therapeutics | Results Halozyme Expands Oncology Pipeline With Two Compounds Designed For Activity In The Tumor Microenvironment halozyme.com ↗
PEGPH20 increases the anticancer activity of standard chemotherapy combinations, vincristine (VIN) and D actinomyc |
| 2016-03-17 | Halozyme Therapeutics | Results Halozyme To Present Data From Five Preclinical Studies At American Association Of Cancer Research Annual Conference halozyme.com ↗
PEGylated recombinant hyaluronidase PH20 enhances pemetrexed antitumor efficacy in a human non-small cell lung cancer model |
| 2016-01-11 | Halozyme Therapeutics | Results Halozyme Provides Key Program Updates, 2016 Financial Guidance At 34th Annual JP Morgan Healthcare Conference halozyme.com ↗
With patient data through Dec. 15, 2015, Halozyme reported a TE event rate in the PEGPH20 arm of 12 percent (9 out of 73 patients) compared to the previously reported 42 percent (31 out of 74 patients) in Stage 1 of the study. |
| 2015-12-09 | Halozyme Therapeutics | Results Halozyme Therapeutics and Eisai to present data evaluating the antitumor effects of PEGPH20 in combination with eribulin mesylate in preclinical breast cancer models halozyme.com ↗
The research showed the potential impact for PEGPH20-mediated hyaluronan (HA) removal on concentrations of eribulin and antitumor effects of breast cancer therapy in preclinical models. |
| 2015-05-31 | Halozyme Therapeutics | Results Halozyme Phase 2 Clinical Study Of Investigational Drug PEGPH20 Shows Doubling Of Progression-free Survival And Improvement Trend In Overall Survival In High HA Metastatic Pancreatic Cancer Patients halozyme.com ↗
A more than doubling of median progression-free survival of 9.2 months versus 4.3 months in high HA patients treated with PAG vs. AG (hazard ratio of 0.39; p-value of 0.05); |
| 2015-02-17 | Halozyme Therapeutics | Results Halozyme Announces Preclinical Study Results Of PEGPH20 Published In Molecular Cancer Therapeutics halozyme.com ↗
PEGPH20 enhances HA-high breast cancer cell killing by trastuzumab and natural killer (NK) cells in vitro. |
| 2014-12-19 | Halozyme Therapeutics | Regulatory Halozyme Receives European Orphan Drug Designation For PEGylated Recombinant Human Hyaluronidase PH20 For Pancreatic Cancer halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA), has designated PEGylated recombinant human hyaluronidase (PEGPH20) an orphan medicinal product for the treatment of pancreatic cancer. |
| 2014-12-12 | Halozyme Therapeutics | Results Halozyme Announces Presentations Of Preclinical Data At The San Antonio Breast Cancer Symposium Annual Meeting halozyme.com ↗
The first of the presentations includes preclinical data showing that treatment of tumors with PEGPH20 enhances the action of immune-based cancer therapy such as monoclonal antibodies (mAbs). |
| 2014-10-09 | Halozyme Therapeutics | Results Halozyme Announces Podium Presentation On PEGPH20 At The New York Academy Of Sciences halozyme.com ↗
The presentation includes preclinical data showing that treatment with PEGPH20 of tumors with high levels of hyaluronan (HA) is associated with alterations of the tumor microenvironment resulting in a reduction of fluid pressure and an increase of blood flow inside the tumors. |
| 2014-10-03 | Halozyme Therapeutics | Regulatory Halozyme Receives Orphan Drug Designation For PEGylated Recombinant Human Hyaluronidase PH20 For Pancreatic Cancer halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for PEGylated recombinant human hyaluronidase (PEGPH20) for the treatment of pancreatic cancer. |
| 2014-09-18 | Halozyme Therapeutics | Regulatory SWOG To Resume Clinical Trial Of Halozyme's PEGPH20 In Combination With Modified FOLFIRINOX For Advanced Pancreatic Cancer halozyme.com ↗ |
| 2014-09-03 | Halozyme Therapeutics | Regulatory Halozyme's PEGPH20 Program In Metastatic Pancreatic Cancer Receives Fast Track Designation halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Halozyme's program investigating PEGPH20 (PEGylated recombinant human hyaluronidase) in combination with gemcitabine and nab-paclitaxel for the treatment of patients with metastatic pancreatic cancer to demonstrate an improvement in overall survival. |
| 2014-06-04 | Halozyme Therapeutics | Regulatory Halozyme To Resume PEGPH20 Clinical Program In Pancreatic Cancer halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on patient enrollment and dosing of PEGPH20 in the ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer permitting the study to resume under a revised protocol. |
| 2014-04-09 | Halozyme Therapeutics | Regulatory Halozyme Announces Clinical Hold of PEGPH20 Pancreatic Cancer Trial Following Voluntary Halt of Trial by Halozyme halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the United States Food and Drug Administration (FDA) informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer. |
| 2014-04-08 | Halozyme Therapeutics | Results Halozyme Announces Preclinical Data Presentations At The Association Of Cancer Research Annual Meeting halozyme.com ↗
The first presentation includes preclinical data showing that treatment of tumors with PEGPH20 enhances the action of immune-based cancer therapy such as monoclonal antibodies (mAbs). |
| 2014-04-04 | Halozyme Therapeutics | Results Halozyme Announces Temporary Halt Of Phase 2 Trial Enrollment And Dosing For PEGPH20 halozyme.com ↗
The DMC is assessing clinical data that indicates a possible difference in the thromboembolic event rate between the group of patients treated with PEGPH20, nab-paclitaxel and gemcitabine versus the group of patients treated with nab-paclitaxel and gemcitabine without PEGPH20. |
| 2013-09-30 | Halozyme Therapeutics | Results Halozyme Presents PEGPH20 Phase 1b Clinical Trial Data at European Cancer Congress 2013 halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced mature patient progression free survival (PFS) and ongoing overall survival (OS) data from a Phase 1b trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in combination with gemcitabine for the treatment of patients with stage IV metastatic pancreatic cancer. |
| 2013-06-03 | Halozyme Therapeutics | Results Halozyme's Phase 1b Clinical Trial Of PEGPH20 With Gemcitabine Indicates Positive Activity Against Pancreatic Cancer halozyme.com ↗
In this single-arm Phase 1b trial, the overall response rate (complete response + partial response) by RECIST 1.1 criteria was 42 percent (95% CI 22 - 62) for those treated at therapeutic dose levels of PEGPH20 (1.6 and 3.0 µg/kg) as assessed by an independent radiology review (n=24). |
| 2013-05-15 | Halozyme Therapeutics | Results Halozyme To Present New Data On PEGPH20 In Pancreatic Cancer At American Society of Clinical Oncology Annual Meeting halozyme.com ↗
The overall response rate (CR+PR) was 42 percent* (n=24) as assessed by independent review at therapeutic dose levels of PEGPH20 (1.6 and 3.0 µg/kg). |
| 2011-10-27 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces Data From Two Phase 1 Studies of PEGPH20 Demonstrating Targeting of Hyaluronan in Tumor Stroma halozyme.com ↗
Tumor imaging from subsets of patients pre- and post-administration of PEGPH20 demonstrated that PEGPH20 treatment rapidly restored tumor perfusion and decreased metabolic activity in tumors. |
| 2009-04-20 | Halozyme Therapeutics | Results Halozyme Studies Target Hyaluronan Surrounding Solid Tumors, May Offer New Approach to Cancer Treatment halozyme.com ↗
Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that treatment with PEGPH20 significantly delayed tumor growth in breast and prostate cancer models. |
| 2009-01-26 | Halozyme Therapeutics | Results Halozyme Therapeutics Presents Positive Pre-Clinical Single Agent Data for PEGPH20 halozyme.com ↗
The study demonstrated that repeat intravenous treatment with PEGPH20 as a single agent in the PC3 mouse model resulted in approximately 70% (p=0.001) tumor growth inhibition compared to controls. |
| 2008-07-22 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models halozyme.com ↗
The study showed that treatment of hormone resistant human prostate cancer in tumor bearing mouse models with intravenous PEGPH20 in combination with the chemotherapeutic drugs, docetaxel (Taxotere(R)) or liposomal doxorubicin (Doxil(R)) resulted in a substantial increase in anti-tumor activity. |
All press releases naming this drug 58 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PEGPH20 | “The Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic...” NCT04045730 ↗15“PEGylated Recombinant Human Hyaluronidase (PEGPH20)” NCT02715804 ↗ |
| Known as | pegvorhyaluronidase alfa | “The Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic...” NCT04045730 ↗3“Safety and pharmacokinetics of docetaxel in combination with pegvorhyaluronidase alfa in patients with non-small cell lung cancer.” PMID 33982408 ↗ Jul 2021 “pegvorhyaluronidase alfa (PEGPH20) degrades HA” PMID 29232172 ↗ Dec 2017 |
| Known as | PEGylated recombinant human hyaluronidase | “A Phase 1B, Randomized, Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Cisplatin Plus Gemcitabine and PEGPH20 in Combination With...” NCT03267940 ↗3“A study of PEGylated recombinant human hyaluronidase (PEGPH20) administered on a twice weekly schedule for 28 days followed by a weekly dosing schedule in patients with...” NCT01170897 ↗ “PEGylated Recombinant Human Hyaluronidase (PEGPH20)” NCT03481920 ↗ “PEGylated Recombinant Human Hyaluronidase (PEGPH20)” NCT02715804 ↗ |
| Known as | PVHA | “pegvorhyaluronidase alfa (PVHA; PEGPH20) on the plasma pharmacokinetics (PKs) and safety of docetaxel” PMID 33982408 ↗ Jul 2021 |
| Modality | Protein / enzyme biologic | “PEGylated recombinant human hyaluronidase” NCT00834704 ↗ |
| Route | Intravenous | “Given intravenously” NCT00834704 ↗ |