-Presentation Includes Newly Reported Objective Response Rate and Patient Baseline Characteristics from HALO-202-
-Results Provide Support for Ongoing HALO-301 Phase 3 Study-
CHICAGO, IL, USA I June 4, 2017 I Encouraging results from a Phase 2 randomized, multi-center clinical trial in pancreas cancer patients conducted by Halozyme Therapeutics (NASDAQ: HALO) were presented today at the American Society of Clinical Oncology (ASCO) annual conference.
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 expanded on findings from patient data as of December 2016 in the HALO-202 study of investigational new drug, PEGPH20 (pegvorhyaluronidase alpha) in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine.
The study met its primary endpoints and the key secondary endpoint of progression-free survival (PFS) in patients with high levels of a biomarker, hyaluronan (HA-High). PEGPH20 plus standard chemotherapy of ABRAXANE and gemcitabine improved median PFS by 77 percent over chemotherapy alone in HA-High patients.
An exploratory endpoint of objective response rate by RECIST v1.1 in the HA-High population, reported for the first time today, was 45 percent in the PEGPH20 plus chemotherapy arm, including one Complete Response, compared to 31 percent in patients receiving chemotherapy alone. Key patient baseline characteristics also reported for the first time today were generally well balanced across both arms of the study.
Halozyme is currently conducting a global Phase 3 clinical trial, HALO-301, in a similar population of HA-High stage IV pancreas cancer patients.
“The HALO-202 study met key safety and efficacy objectives and confirmed in a randomized Phase 2 trial that a biomarker may be able to identify patients who will have a meaningfully greater response when PEGPH20 is added to standard-of-care chemotherapy,” said Dr. Hingorani. “The new data reported today suggest potentially important progress in this very difficult to treat cancer.”
Dr. Helen Torley, president and chief executive officer of Halozyme, said, “We are driven in our study of PEGPH20 by the goal of providing new options to patients affected by some of the hardest to treat cancers. The HALO-202 results in HA-High pancreas cancer patients provide encouraging insights into a potentially new treatment option and support our ongoing study of PEGPH20 in the global Phase 3 HALO-301 study.”
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 (pegvorhyaluronadase alpha)
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.
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, 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.
SOURCE: Halozyme Therapeutics
Post Views: 23
-Presentation Includes Newly Reported Objective Response Rate and Patient Baseline Characteristics from HALO-202-
-Results Provide Support for Ongoing HALO-301 Phase 3 Study-
CHICAGO, IL, USA I June 4, 2017 I Encouraging results from a Phase 2 randomized, multi-center clinical trial in pancreas cancer patients conducted by Halozyme Therapeutics (NASDAQ: HALO) were presented today at the American Society of Clinical Oncology (ASCO) annual conference.
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 expanded on findings from patient data as of December 2016 in the HALO-202 study of investigational new drug, PEGPH20 (pegvorhyaluronidase alpha) in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine.
The study met its primary endpoints and the key secondary endpoint of progression-free survival (PFS) in patients with high levels of a biomarker, hyaluronan (HA-High). PEGPH20 plus standard chemotherapy of ABRAXANE and gemcitabine improved median PFS by 77 percent over chemotherapy alone in HA-High patients.
An exploratory endpoint of objective response rate by RECIST v1.1 in the HA-High population, reported for the first time today, was 45 percent in the PEGPH20 plus chemotherapy arm, including one Complete Response, compared to 31 percent in patients receiving chemotherapy alone. Key patient baseline characteristics also reported for the first time today were generally well balanced across both arms of the study.
Halozyme is currently conducting a global Phase 3 clinical trial, HALO-301, in a similar population of HA-High stage IV pancreas cancer patients.
“The HALO-202 study met key safety and efficacy objectives and confirmed in a randomized Phase 2 trial that a biomarker may be able to identify patients who will have a meaningfully greater response when PEGPH20 is added to standard-of-care chemotherapy,” said Dr. Hingorani. “The new data reported today suggest potentially important progress in this very difficult to treat cancer.”
Dr. Helen Torley, president and chief executive officer of Halozyme, said, “We are driven in our study of PEGPH20 by the goal of providing new options to patients affected by some of the hardest to treat cancers. The HALO-202 results in HA-High pancreas cancer patients provide encouraging insights into a potentially new treatment option and support our ongoing study of PEGPH20 in the global Phase 3 HALO-301 study.”
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 (pegvorhyaluronadase alpha)
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.
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, 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.
SOURCE: Halozyme Therapeutics
Post Views: 23
