Halozyme Phase 2 Clinical Study Of Investigational Drug PEGPH20 Shows Doubling Of Progression-free Survival And Improvement Trend In Overall Survival In High HA Metastatic Pancreatic Cancer Patients

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Encouraging Reduction In Thromboembolic Events Following Protocol Amendment

SAN DIEGO, May 31, 2015 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced interim findings from the ongoing phase 2 clinical study of its investigational new drug PEGPH20 for the potential treatment of patients with metastatic pancreatic cancer.

The encouraging interim data was presented today at the American Society of Clinical Oncology annual meeting in an oral presentation by Principal Investigator Sunil Hingorani, M.D., Ph.D., Associate Member of the Fred Hutchinson Cancer Research Center and Associate Professor at University of Washington School of Medicine.

The trial included 135 treated patients in stage 1, of whom a total of 44 patients -- 23 receiving PEGPH20 in combination with  ABRAXANE® and gemcitabine (PAG treatment arm) and 21 receiving ABRAXANE and gemcitabine alone (AG treatment arm) -- had available biopsies that were determined in a retrospective analysis to have high levels of hyaluronan (HA). PEGPH20 targets HA to help improve cancer therapy access to tumor cells. Results reported include:  

  • A more than doubling of median progression-free survival of 9.2 months versus 4.3 months in high HA patients treated with PAG vs. AG (hazard ratio of 0.39; p-value of 0.05);
  • A more than doubling of overall response rate of 52 percent versus 24 percent (p-value of 0.038) and a duration of response of 8.1 months compared to 3.7 months in high HA patients treated with PAG versus AG;
    • In the 30 high HA patients (15 PAG treatment arm versus 15 AG treatment arm) who were evaluated for response prior to the April 2014 clinical hold and subsequent PEGPH20 treatment discontinuation, the overall response rate was 73 percent versus 27 percent (p-value of 0.01), respectively, consistent with findings presented in January;
  • A trend toward improvement in median overall survival of 12 months compared to 9 months in high HA patients treated with PAG versus AG (hazard ratio of 0.62) despite discontinuation of PEGPH20 in more than half of the PAG-treated patients at the time of the clinical hold in April 2014.

Data was also presented on the rate of thromboembolic (TE) events in 55 patients treated in stage 2 of the trial, which is currently randomizing patients at a 2:1 ratio of PAG versus AG. Stage 2 began after a protocol amendment in July 2014, excluding patients at high risk of TE events and adding prophylaxis with low molecular weight heparin (enoxaparin) to all patients in both treatment arms. Reported results included:

  • A TE event rate of 13 percent in 38 patients treated with PAG versus 18 percent in 17 patients receiving AG;
  • In the 20 PAG patients receiving 1 mg/kg/day of enoxaparin, no TE events have been reported to date.

"The interim results from the ongoing study are very encouraging," said Dr. Hingorani. "We have a high unmet need in pancreas cancer and the trend we observed toward longer survival rates and the slowing of disease progression are noteworthy in a cancer that has seen very few therapeutic developments in the past several years."

"We remain very encouraged by the interim data presented today from our ongoing phase 2 study, including the positive trend in overall survival, and we continue to plan for the first-quarter 2016 initiation of our phase 3 study," said Dr. Athena Countouriotis, senior vice president and chief medical officer.

HA is a glycosaminoglycan – or chain of natural sugars throughout the body – that can accumulate around cancer cells inhibiting other therapies. PEGPH20 is designed to degrade HA to improve the access to tumor cells for chemotherapy, monoclonal antibodies and other immuno-therapy agents.

Halozyme previously announced it plans to proceed in Q1 2016 with a phase 3 clinical study (Study 301) of PEGPH20 in patients with metastatic pancreatic cancer, using a design allowing for potential marketing application based on either progression-free survival or overall survival. The use of progression-free survival as the basis for marketing approval will be subject to the overall benefit and risk profile associated with PEGPH20 combined with ABRAXANE and gemcitabine therapy, including the:

  • Magnitude of the progression-free survival treatment effect observed;
  • Toxicity profile; and
  • Interim overall survival data.

About Study 202
Study 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 pancreatic 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 will assess the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival. More information may be found at: http://oncologytrials.halozyme.com/pancreatic/

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.

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, 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 pancreatic cancer.

About Halozyme
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, an investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor.  PEGPH20 is currently in development for metastatic pancreatic cancer and non-small cell lung cancer and has potential across additional cancers in combination with different types of therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Pfizer, Janssen and Baxter for its drug delivery platform, ENHANZE™, which enables biologics and small molecule compounds that are currently administered intravenously to be delivered subcutaneously. 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 11, 2015.

Schond Greenway
Halozyme Therapeutics

Jim Mazzola
Halozyme Therapeutics

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