FDA Removes Clinical Hold On Halozyme's PEGPH20 For Pancreatic Cancer

Halozyme Therapeutics announced in a press release that the Food and Drug Administration (FDA) has removed its clinical hold on PEGPH20. This allows the company to resume a Phase II trial, Study 202, for patients with pancreatic cancer. The study will resume with a revised protocol addressing thromboembolic event risks. After a review of the amended protocol by the participating clinical trial sites, Halozyme will resume enrolling patients.

Dr. Helen Torley, President and CEO of Halozyme, said, "We are committed to the development of PEGPH20 in pancreatic cancer. Halozyme worked diligently with the FDA and the DMC (Data Monitoring Committee) to develop the plan to allow the study to restart. We are pleased to be able to continue enrolling patients in this clinical program as there remains a significant need for new treatment options for pancreatic cancer patients."

PEGPH20

PEGPH20 is an investigational form of recombinant human hyaluronidase targeting the accumulation of hyaluronan (HA). In certain cancers, pathologic accumulation of HA forms a matrix around the tumor, increasing interstitial fluid pressure and an environment where tumor cells flourish. This mechanism has presented difficulties for cancer drugs. PEGPH20 addresses the HA component and opens constricted blood vessels, allowing cancer drugs to reach their targets.  

PEGPH20 Study 202

The PEGPH20 Study 202 is under the jurisdiction of an independent Data Monitoring Committee (DMC), which recommended a revised protocol in May. The FDA’s removal of the clinical hold allows the trial to continue enrolling and dosing patients. Study 202 (Halo 109-202) is a Phase II multicenter trial testing PEGPH20 as a first-line therapy for treatment of patients with stage IV metastatic pancreatic cancer. Investigators are primarily looking at improvements in progression-free survival in patients receiving PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone.

The amended protocol includes a secondary endpoint of assessing thromboembolic event rates in the PEGPH20 treatment arm. Also amended was the inclusion of patients who have a high risk of thromboembolic events; they are to be excluded. To prevent thromboembolic events, Halozyme is authorized to administer low-molecular weight heparin. Other measures in the study include the objective response rate and overall survival rate. There are currently 100 people already enrolled and the company plans to enroll another 100 patients.