Investigational pancreatic cancer drug trial resumes patient enrollment, dosing

Halozyme Therapeutics recently announced that it has resumed enrollment and dosing of patients in its Study 202 trial, evaluating its investigational pegylated formulation of recombinant human hyaluronidase in pancreatic cancer, under a revised clinical protocol agreement with the FDA.

Study 202 is a phase 2 multicenter, randomized clinical trial evaluating Haolzyme’s PEGPH20 as a first-line therapy for treatment of patients with stage IV metastatic pancreatic cancer. The primary outcome of the trial is to measure improvement in PFS in patients receiving PEGPH20 in combination with gemcitabine and nab-paclitaxel vs. gemcitabine and nab-paclitaxel alone.

Following the protocol amendment, a second primary endpoint has been added to assess the thromboembolic event rate in the PEGPH20 treatment group. Secondary endpoints include objective response rate and OS. The protocol amendments to the study include the exclusion of patients who may be at higher risk of thromboembolic events. Additionally, low-molecular weight heparin will be used as a prophylaxis to prevent thromboembolic events.

“Our diligent effort to rapidly re-initiate patient enrollment and dosing of both previously enrolled and new patients in this trial underscores our commitment to evaluating the potential role of PEGPH20 in patients with stage 4 metastatic pancreatic cancer,” Helen Torley, MBChB, MRCP, president and chief executive officer, said in a press release. “Approximately 50% of the anticipated clinical sites have received IRB approvals, and we anticipate continued IRB approvals in the coming weeks.