BARCELONA, Spain, June 28, 2017 /PRNewswire/ -- Results from Halozyme Therapeutics (NASDAQ: HALO) Phase 2 randomized, multi-center clinical trial in pancreas cancer patients were shared today in two oral presentations at the European Society for Medical Oncology's 19th World Congress on Gastrointestinal Cancer.
The HALO-202 study represents the first clinical trial of a molecularly targeted drug in pancreatic ductal adenocarcinoma and the results support hyaluronan (HA) as a potential biomarker to predict those patients who could benefit from Halozyme's investigational new drug PEGPH20 (pegvorhyaluronidase alfa) when added to standard chemotherapy.
As previously reported, the study met its primary efficacy and safety endpoints and the key secondary endpoint of progression-free survival (PFS) in HA-High patients. PEGPH20 plus standard chemotherapy of ABRAXANE® (nab-paclitaxel) and gemcitabine improved median PFS by 77 percent over chemotherapy alone in HA-High patients.
Dr. Andrew Hendifar, the medical oncology lead for the Gastrointestinal Disease Research Group at Cedars-Sinai and co-director of Pancreas Oncology delivered the presentation, "PEGPH20 Improves PFS in Patients With Metastatic Pancreatic Ductal Adenocarcinoma: A Randomized Phase 2 Study in Combination With nab-Paclitaxel/Gemcitabine."
Dr. Andrea Bullock, attending physician in Gastrointestinal Oncology at Beth Israel Deaconess Medical Center and an Instructor in Medicine at Harvard University delivered the presentation, "Tumor Hyaluronan May Predict Benefit From PEGPH20 When Added to nab-Paclitaxel/Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDA)."
New safety data reported today show bleeding events were balanced between the two arms after the introduction of low molecular weight heparin in stage 2 of the study.
"The results of HALO-202 are encouraging and continue to support our ongoing HALO-301 phase 3 study in HA-High pancreas cancer patients," said Dr. Helen Torley, president and chief executive officer. "HALO-301 is now open for screening and enrollment at more than 200 centers in over 20 countries."
In addition to the oral presentations, Halozyme and its investigators are presenting three posters pertaining to the study of PEGPH20, including:
- Musculoskeletal Adverse Events with PEGPH20 Treatment and Management in Patients with Previously Untreated Metastatic PDA (HALO-202), presented by Dr. Bullock;
- Global, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of PEGPH20 + nab-Paclitaxel & Gemcitabine in Pts with Previously Untreated, HA-High, Stage IV PDA (HALO-301), presented by Dr. E. Von Cutsem, a principal investigator in the study; and
- A Systematic Review Examining the Relationship Between PFS and OS Survival In Adults With Untreated Metastatic Pancreatic Cancer, presented by Halozyme.
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 (pegvorhyaluronidase alfa)
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.
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreas cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE® drug delivery platform. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible activity, benefits and attributes of PEGPH20, the possible method of action of PEGPH20, its potential application to improve cancer therapies and statements concerning future actions relating to the development of PEGPH20) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission.
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SOURCE Halozyme Therapeutics, Inc.