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DRUG:

pegvorhyaluronidase alfa (PEGPH20)

i
Other names: PEGylated Recombinant Human Hyaluronidase, PEG PH20, PEG rHuPH-20, PEGPH20, PEG rHuPH20, pegylated rHuPH20
Company:
Halozyme, Nektar Therap
Drug class:
Hyaluronidase stimulant
Related drugs:
17d
MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
P1/2, N=340, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Oct 2026 --> Jan 2025 | Trial primary completion date: Oct 2025 --> Jan 2025
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
2ms
Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
HER-2 negative • HER-2 expression
|
cisplatin • Tecentriq (atezolizumab) • paclitaxel • 5-fluorouracil • Cotellic (cobimetinib) • Cyramza (ramucirumab) • oxaliplatin • leucovorin calcium • tiragolumab (RG6058) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide)
4ms
Hyaluronidase improves the efficacy of nab-paclitaxel after prolonged angiogenesis inhibition in preclinical models for esophagogastric cancer. (PubMed, Biomed Pharmacother)
These findings suggest that the mechanical barrier of HA is the major reason responsible for the resistance developed during prolonged anti-angiogenesis in EGC. Incorporating PEGPH20 into the existing treatment regimen is promising to improve outcomes for patients with EGC.
Preclinical • Journal
|
CD31 (Platelet and endothelial cell adhesion molecule 1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
|
albumin-bound paclitaxel • DC101 • nitroglycerin • pegvorhyaluronidase alfa (PEGPH20)
5ms
Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
P=N/A, N=110, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Metastases
|
gemcitabine • albumin-bound paclitaxel • pegvorhyaluronidase alfa (PEGPH20)
10ms
S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=126, Completed, SWOG Cancer Research Network | Active, not recruiting --> Completed
Trial completion
|
5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • pegvorhyaluronidase alfa (PEGPH20)
12ms
Enrollment closed
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
1year
Monitor PDAC Tumor Response to Stroma-Targeting Therapy using CEST MRI (RSNA 2023)
We have evaluated dextran-enhanced CEST MRI’s ability to assess tumor responses to stroma-targeting therapy. Our data indicates that 10 kD dextran is suitable for monitoring the tumor responses to PEGPH20. Reference : 1.
Stroma
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS G12D • KRAS G12
|
pegvorhyaluronidase alfa (PEGPH20)
1year
Enrollment closed • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
HER-2 negative • HER-2 expression
|
cisplatin • Tecentriq (atezolizumab) • paclitaxel • 5-fluorouracil • Cotellic (cobimetinib) • Cyramza (ramucirumab) • oxaliplatin • leucovorin calcium • tiragolumab (RG6058) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide)
over1year
MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
P1/2, N=340, Recruiting, Hoffmann-La Roche | Trial completion date: Jun 2024 --> Oct 2026 | Trial primary completion date: Jun 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
over1year
Impact of Arterial Input Function and Pharmacokinetic Models on DCE-MRI Biomarkers for Detection of Vascular Effect Induced by Stroma-Directed Drug in an Orthotopic Mouse Model of Pancreatic Cancer. (PubMed, Mol Imaging Biol)
Our results suggest that k derived from SSM and V from ETM, both using group AIF, are optimal for the detection of microvascular changes induced by stroma-directed drug PEGPH20. These analyses provide insights in the choice of PK model and AIF for optimal DCE protocol design in mouse pancreatic cancer models.
PK/PD data • Preclinical • Retrospective data • Journal • Stroma
|
pegvorhyaluronidase alfa (PEGPH20)
over1year
Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
P=N/A, N=110, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
Trial completion date • Trial primary completion date • Metastases
|
gemcitabine • albumin-bound paclitaxel • pegvorhyaluronidase alfa (PEGPH20)
over1year
Investigating the contribution of hyaluronan to the breast tumour microenvironment using multiparametric MRI and MR elastography. (PubMed, Mol Oncol)
Treatment of MDA-MB-231 LM2-4 tumours reduced ADC and dramatically increased tumour viscoelasticity measured by MR elastography. Correlation matrix analyses of data from all models identified ADC as having the strongest correlation with HA accumulation, suggesting that ADC is the most sensitive imaging biomarker of tumour response to PEGPH20.
Journal
|
HAS3 (Hyaluronan Synthase 3)
|
pegvorhyaluronidase alfa (PEGPH20)
over1year
Atezolizumab Plus PEGPH20 Versus Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Gastric Cancer: MORPHEUS Phase Ib/II Umbrella Randomized Study Platform. (PubMed, Oncologist)
Atezolizumab plus PEGPH20 showed limited clinical activity in patients with PDAC and none in patients with GC. The safety of atezolizumab plus PEGPH20 was consistent with each agent's known safety profile. (ClinicalTrials.gov Identifier: NCT03193190 and NCT03281369).
P1/2 data • Journal • Metastases
|
Tecentriq (atezolizumab) • gemcitabine • albumin-bound paclitaxel • Cyramza (ramucirumab) • oxaliplatin • leucovorin calcium • pegvorhyaluronidase alfa (PEGPH20)
over2years
Cell-Free Tumor DNA Dominant Clone Allele Frequency Is Associated With Poor Outcomes in Advanced Biliary Cancers Treated With Platinum-Based Chemotherapy. (PubMed, JCO Precis Oncol)
DCAF at diagnosis of advanced BTC can stratify patients who have worse outcomes when treated with upfront platinum-based chemotherapy. Each increase in %ctDNA decreases survival probabilities.
Retrospective data • Journal • Circulating tumor DNA
|
KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • STK11 (Serine/threonine kinase 11) • ARID1A (AT-rich interaction domain 1A) • CA 19-9 (Cancer antigen 19-9)
|
cisplatin • carboplatin • gemcitabine • albumin-bound paclitaxel • oxaliplatin • pegvorhyaluronidase alfa (PEGPH20) • silmitasertib (CX-4945)
over2years
PEGPH20, a PEGylated human hyaluronidase, induces radiosensitization by reoxygenation in pancreatic cancer xenografts. A molecular imaging study. (PubMed, Neoplasia)
PEGPH20 may be useful for radiosensitization of pancreatic cancer but only in the subset of tumors with substantial hyaluronan accumulation. The response of the treatment may potentially be monitored by non-invasive imaging of the hemodynamic and metabolic changes in the tumor microenvironment.
Journal
|
HAS3 (Hyaluronan Synthase 3)
|
HAS3 expression • HAS3 overexpression
|
pegvorhyaluronidase alfa (PEGPH20)
over2years
Enrollment open
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
over2years
Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
HER-2 negative • HER-2 expression
|
cisplatin • Tecentriq (atezolizumab) • paclitaxel • 5-fluorouracil • Cotellic (cobimetinib) • Cyramza (ramucirumab) • oxaliplatin • leucovorin calcium • tiragolumab (RG6058) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide)
over2years
Multimodal molecular imaging detects early reoxygenation induced by hyaluronan depletion in pancreatic cancer model mouse (AACR 2022)
PEGPH20 enhanced treatment effect of radiation therapy. The results validated the utility of the imaging methods to non-invasively monitor the changes in TME and predicted the radiosensitizing effect of hyaluronan depletion.
Preclinical
|
HAS3 (Hyaluronan Synthase 3)
|
pegvorhyaluronidase alfa (PEGPH20)
almost3years
MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
P1/2, N=290, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Nov 2022 --> Jun 2024 | Trial primary completion date: Nov 2022 --> Jun 2024
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
3years
PEGylated recombinant human hyaluronidase (PEGPH20) pre-treatment improves intra-tumour distribution and efficacy of paclitaxel in preclinical models. (PubMed, J Exp Clin Cancer Res)
Remodelling the stroma of HA-rich tumours by depletion of HA with PEGPH20 pre-treatment, is a potentially successful strategy to improve the intra-tumour distribution of anticancer drugs, increasing their therapeutic efficacy, without increasing toxicity.
Preclinical • Journal
|
HAS3 (Hyaluronan Synthase 3)
|
paclitaxel • pegvorhyaluronidase alfa (PEGPH20)
over3years
Clinical • Enrollment closed
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
over3years
Clinical • Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
HER-2 negative • HER-2 expression
|
cisplatin • Tecentriq (atezolizumab) • paclitaxel • 5-fluorouracil • Cotellic (cobimetinib) • Cyramza (ramucirumab) • oxaliplatin • leucovorin calcium • tiragolumab (RG6058) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide)
over3years
MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov)
P1/2, N=290, Recruiting, Hoffmann-La Roche | Trial completion date: Nov 2021 --> Nov 2022 | Trial primary completion date: Nov 2021 --> Nov 2022
Clinical • Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
almost4years
Blood-based extracellular matrix biomarkers as predictors of survival in patients with metastatic pancreatic ductal adenocarcinoma receiving pegvorhyaluronidase alfa. (PubMed, J Transl Med)
The C3M/PRO-C3 ratio measuring type III collagen turnover in plasma has potential as a blood-based predictive biomarker in patients with mPDA and provides additional value to a HA biopsy when applied for patient selection.
Clinical • Journal
|
VCAN (Versican)
|
gemcitabine • albumin-bound paclitaxel • pegvorhyaluronidase alfa (PEGPH20)
over4years
Clinical • Enrollment change • Trial termination • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Halaven (eribulin mesylate) • pegvorhyaluronidase alfa (PEGPH20)
over4years
Predicting gemcitabine delivery by F-FAC PET in murine models of pancreatic cancer. (PubMed, J Nucl Med)
[F]-FAC PET was shown to be a good surrogate for gemcitabine uptake, and when combined with MR, to successfully determine drug uptake in tumors growing in the pancreas. PEGPH20 had moderate effects on tumor uptake of gemcitabine.
Journal
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS G12D • KRAS G12
|
gemcitabine • pegvorhyaluronidase alfa (PEGPH20)
over4years
Clinical • Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
HER-2 negative • HER-2 expression
|
cisplatin • Tecentriq (atezolizumab) • paclitaxel • 5-fluorouracil • Cotellic (cobimetinib) • Cyramza (ramucirumab) • oxaliplatin • leucovorin calcium • tiragolumab (RG6058) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide)
over4years
[VIRTUAL] 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 (AACR-II 2020)
Stromal degradation of hyaluronan via PEGPH20 in combination with FAKi and anti-PD-1 antibody further depletes immunosuppressive cells in the TME including G-MDSCs, inflammatory resident monocytes and PD-L1 expressing myeloid cells, and appears to target the CXCR4 pathway through PEGPH20. These findings support testing the combination of FAKi and anti-PD-1 antibody with agents targeting CXCR4 directly or indirectly by PEGPH20 in human PDAC.
Preclinical
|
PD-L1 (Programmed death ligand 1) • CXCR4 (Chemokine (C-X-C motif) receptor 4)
|
PD-L1 expression
|
pegvorhyaluronidase alfa (PEGPH20)
over4years
Trial completion date • Trial primary completion date • Clinical
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
over4years
Pembrolizumab and PEGPH20 in Treating Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
P2, N=0, Withdrawn, M.D. Anderson Cancer Center | N=15 --> 0 | Not yet recruiting --> Withdrawn
Clinical • Enrollment change • Trial withdrawal
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • pegvorhyaluronidase alfa (PEGPH20)
almost5years
Why HALO 301 Failed and Implications for Treatment of Pancreatic Cancer. (PubMed, Pancreas (Fairfax))
Based on this, stromal modifying agent such as Pegvorhyaluronidase alfa (PEGPH20) was developed and investigated in phase I-III studies...It is also important to consider that although the tumor stroma may be a physical barrier hampering drug delivery, it may also have protective effects in restraining tumor growth and progression. Further studies in molecular biology to better characterize the complex interaction between the microenvironment and cancer cells are warranted.
Journal • Tumor Mutational Burden
|
TMB (Tumor Mutational Burden)
|
pegvorhyaluronidase alfa (PEGPH20)
almost5years
Pembrolizumab and PEGPH20 in Treating Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
P2, N=15, Not yet recruiting, M.D. Anderson Cancer Center | Trial completion date: Oct 2021 --> Oct 2022 | Initiation date: Oct 2019 --> Feb 2020 | Trial primary completion date: Oct 2020 --> Oct 2022
Clinical • Trial completion date • Trial initiation date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • pegvorhyaluronidase alfa (PEGPH20)
almost5years
Trial completion date • Trial primary completion date • Clinical
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)
almost5years
Clinical • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
cisplatin • Tecentriq (atezolizumab) • gemcitabine • pegvorhyaluronidase alfa (PEGPH20)
6years
Trial completion date • Clinical
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • gemcitabine • 5-fluorouracil • Cotellic (cobimetinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Actemra IV (tocilizumab) • tiragolumab (RG6058) • etrumadenant (AB928) • pegvorhyaluronidase alfa (PEGPH20) • Aphexda (motixafortide) • selicrelumab (RG7876) • simlukafusp alfa (RG7461)