On May 17, 2017 Halozyme Therapeutics (NASDAQ: HALO) reported that results from a Phase 2 randomized, multi-center clinical trial in pancreas cancer patients of its targeted investigational therapy, PEGPH20, will be presented in an oral presentation on June 4 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual conference (Press release, Halozyme, MAY 17, 2017, View Source [SID1234519199]). Schedule your 30 min Free 1stOncology Demo! Principal Investigator Sunil R. Hingorani, M.D., Ph.D., a pancreas cancer expert at Fred Hutchinson Cancer Research Center and professor at University of Washington School of Medicine will present the HALO-202 results, which include the study meeting its primary and key secondary endpoints.
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"The HALO-202 data confirm for the first time in a randomized Phase 2 trial using the current standard of care that a biopsy-based biomarker for hyaluronan content can potentially identify patients who will have a meaningfully greater response when PEGPH20 is added to their treatment," said Dr. Hingorani. "The analysis suggests statistically significant and clinically important progress in this very difficult to treat cancer. The median PFS is a notable increase over the current standard of care and supports ongoing exploration in the current Phase 3 study."
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). Halozyme is currently enrolling HA-High patients in a global Phase 3 clinical trial.
In a subanalysis of patients who received uninterrupted therapy with PEGPH20 plus chemotherapy (Stage 2 patients), a 91 percent improvement in mPFS and a 4-month benefit in overall survival were observed.
Dr. Helen Torley, president and chief executive officer of Halozyme said, "The results in the HA-High patient cohort are particularly encouraging given that we are using this biomarker and recruiting this specific patient population in our ongoing global Phase 3 study, HALO-301. We believe that HALO-301 is the first targeted or biomarker driven Phase 3 study to date in this highly lethal cancer type."
Pancreas cancer is the third-leading cause of cancer related death in the United States, and more than 65,000 people in the U.S. and top five European countries are diagnosed annually with advanced cases of the disease.
About HALO-301 and HALO-202
HALO-301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The trial will be conducted at approximately 200 sites with two primary endpoints, progression free survival and overall survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone. Secondary endpoints also include objective response rate and overall survival. More information may be found at clinicaltrials.gov (search HALO 301 or trial identifier NCT02715804) or www.HALO301.com.
HALO-202 (Halo 109-202) is a phase 2 multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. A second primary endpoint assesses the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival.
About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies.
FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track designation for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.