On November 5, 2015 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the first patient has received its investigational new drug, PEGPH20 in combination with Merck’s KEYTRUDA (pembrolizumab) in a clinical trial to determine the maximum tolerated dose of PEGPH20 and antitumor activity of the combined therapies (Press release, Halozyme, NOV 5, 2015, View Source [SID:1234508009]).

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The Halozyme sponsored Phase 1b study is being conducted at a number of leading sites in the U.S., and is evaluating patients with advanced non-small cell lung and gastric cancers.

Following an initial dose escalation portion to determine the maximum tolerated dose of PEGPH20 in combination with KEYTRUDA, the study will be expanded to determine antitumor activity including overall response rate, duration of response and progression-free survival in patients with high levels of hyaluronan (HA). HA is a glycosaminoglycan, or chain of natural sugars in the body that can accumulate around cancer cells creating high pressure in a tumor, constricting blood flow and thereby reducing access of chemotherapy and immunotherapeutic agents, like KEYTRUDA. PEGPH20 degrades HA, reducing tumor pressure and increasing blood flow to treat the tumor.

During the expansion portion, the study seeks to enroll approximately 50 patients with high HA tumors who have relapsed or refractory stage IIIB/IV non-small cell lung cancer treated with at least one platinum-based regimen, or who have recurrent locally advanced/metastatic gastric adenocarcinoma who are also PDL-1 positive and have failed at least one chemotherapy regimen.

"Our goal is to make a difference in the lives of patients, and that starts by studying the safety, tolerability and efficacy of PEGPH20 in a broad range of tumor types and in combination with a broad range of therapeutic agents," said Dr. Helen Torley, president and CEO of Halozyme. "With this study, we see an opportunity to expand the potential benefits of immunotherapy through the novel combination of KEYTRUDA and PEGPH20, targeting two of the most difficult to treat cancers."

For information on Keytruda, please go to keytruda.com.

About PEGPH20

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, 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.