Date: 2016-03-16
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Halozyme Therapeutics (USA - CA)
Product: pegylated recombinant human hyaluronidase - PEGPH20 In combination With Abraxane® (nab-paclitaxel) and gemcitabine
Action
mechanism: enzyme. 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.
Disease: pancreatic ductal adenocarcinoma
Therapeutic area: Cancer - Oncology
Country: Australia, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Republic of Korea, Latvia, Lithuania, The Netherlands, Poland, Spain, Taiwan, UK, USAQ
Trial
details: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). Participants will be randomized in a 2:1 ratio to PAG or AG treatment. (NCT02715804)
Latest
news: * On March 16, 2016, Halozyme Therapeutics announced the first patient has been dosed in its Halo-301 | Pancreatic study, a Phase 3 clinical trial in previously untreated metastatic pancreatic cancer patients. The global, randomized, double-blind, placebo controlled trial will study Halozyme's investigational drug, PEGPH20, in combination with Abraxane® (nab-paclitaxel) and gemcitabine in patients identified to have tumors that accumulate high levels of hyaluronan (HA). HA is a glycosaminoglycan that may impede access of drugs targeting the tumor. Halozyme's PEGPH20 temporarily degrades HA and has been shown in animal models to increase the concentration of co-administered therapies in the targeted tumor. Halozyme also announced that the investigational device exemption (IDE) submitted to the FDA last month by Halozyme's partner Ventana Medical Systems has been approved. This IDE allows Halozyme to use the Ventana HA CDx Assay as the companion diagnostic in Halo-301 to prospectively identify HA-High patients for inclusion in the study. Halo-301 has an enrollment target of 420 HA-high patients and seeks to improve progression-free survival and overall survival in the patients receiving PEGPH20 plus Abraxane® and gemcitabine compared to those receiving placebo plus Abraxane® and gemcitabine. * On April 8, 2015, Halozyme Therapeutics announced it plans to proceed with a Phase 3 clinical study (Study 301) of its investigational new drug PEGPH20 in patients with metastatic pancreatic cancer, using a design allowing for potential marketing application based on either progression free survival (PFS) or overall survival. The use of PFS as the basis for marketing approval will be subject to the overall benefit and risk associated with PEGPH20 combined with nab-paclitaxel (Abraxane®) and gemcitabine therapy, including the magnitude of the PFS treatment effect observed; the toxicity profile; and interim overall survival data. The study will enroll patients whose tumors accumulate high levels of hyaluronan (HA) – a sugar that is sometimes more prevalent in the areas surrounding cancer cells. Halozyme recently discussed the study as part of a planned Type B meeting with the FDA. Data discussed at the meeting focused on interim results from the company's randomized Phase 2 study in pancreatic cancer, Study 202, which showed a doubling in median PFS in metastatic pancreatic cancer patients with high levels of HA who were treated with Halozyme's investigational new drug PEGPH20 combined with nab-paclitaxel (Abraxane®) and gemcitabine (9.2 months vs. 4.3 months in patients treated with nab-paclitaxel Abraxane® and gemcitabine alone). The potential risk profile, including rate of thromboembolic events, was also discussed. Additional takeaways from the meeting include: Halozyme affirmed plans to enroll and evaluate high-HA patients using a companion diagnostic test. FDA provided feedback on the current companion diagnostic approach and confirmed that an approved companion diagnostic strategy is required prior to Phase 3 study initiation. Based on this FDA feedback, the company is targeting the end of first quarter 2016 to initiate the Phase 3 study.
