Date: 2016-07-25
Type of
information: update on patient enrollment
phase: 1b
Announcement: update on patient enrollment
Company: Halozyme Therapeutics (USA - CA)
Product: PEGPH20 and pembrolizumab
Action
mechanism:
- enzyme/monoclonal antibody/immune checkpoint inhibitor. PEGPH20 (PEGylated recombinant human hyaluronidase) targets the degradation of hyaluronan (HA), a chain of natural sugars that can accumulate around cancer cells, inhibiting other therapies. By degrading HA, PEGPH20 may increase the access of co-administered chemotherapeutic and immunotherapeutic agents. FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.
- Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination.
Disease: non-small cell lung cancer (NSCLC), gastric cancer
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This phase 1b study is evaluating a combination of PEGPH20 and pembrolizumab for subjects with relapsed/refractory advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have failed at least 1 platinum-based chemotherapy regimen and subjects with relapsed/refractory locally advanced or metastatic gastric adenocarcinoma after failing at least 1 chemotherapy regimen. (NCT02563548)
Latest
news:
- • On July 25, 2016, Halozyme Therapeutics announced that it has resumed the enrollment and dosing of patients in its ongoing Phase 1b trial evaluating its investigational new drug, PEGPH20, in combination with Keytruda® (pembrolizumab) in patients with advanced non-small cell lung and gastric cancers under a revised clinical protocol. The revised protocol has been submitted to all institutional review boards (IRB) and is pending feedback from the FDA. The majority of IRBs have completed their review and approved the revised protocol allowing the study to resume. The Phase 1b study will enroll up to approximately 80 patients at a number of leading sites in the United States.
- • On November 5, 2015, Halozyme Therapeutics announced the first patient has received its investigational new drug, PEGPH20 in combination with Merck's Keytruda® (pembrolizumab) in a clinical trial to determine the maximum tolerated dose of PEGPH20 and antitumor activity of the combined therapies. The Halozyme sponsored Phase 1b study is being conducted at a number of leading sites in the U.S., and is evaluating patients with advanced non-small cell lung and gastric cancers. Following an initial dose escalation portion to determine the maximum tolerated dose of PEGPH20 in combination with Keytruda®, the study will be expanded to determine antitumor activity including overall response rate, duration of response and progression-free survival in patients with high levels of hyaluronan. This glycosaminoglycan can accumulate around cancer cells creating high pressure in a tumor, constricting blood flow and thereby reducing access of chemotherapy and immunotherapeutic agents, like Keytruda®. PEGPH20 degrades HA, reducing tumor pressure and increasing blood flow to treat the tumor.
- During the expansion portion, the study seeks to enroll approximately 50 patients with high HA tumors who have relapsed or refractory stage IIIB/IV non-small cell lung cancer treated with at least one platinum-based regimen, or who have recurrent locally advanced/metastatic gastric adenocarcinoma who are also PDL-1 positive and have failed at least one chemotherapy regimen.
Is
general: Yes
