PEGPH20: Phase Ib/II ongoing

Halozyme said FDA lifted a full clinical hold on the open-label, U.S. Phase Ib/II S1313 trial comparing IV PEGPH20 in combination with modified FOLFIRINOX (5-fluorouracil (5-FU), leucovorin, irinotecan and oxaliplatin) chemotherapy vs. modified FOLFIRINOX chemotherapy alone in about 170 patients. FDA placed the hold in April due to the risk of thromboembolic events. The company said S1313 will immediately resume under a revised protocol. Cancer research cooperative group SWOG is sponsoring the trial, which the NCI is funding.

Under the revised protocol, the dose de-escalation Phase Ib run-in portion will enroll 6-18 patients to evaluate DLTs and determine the optimal dose for the Phase II portion, which will enroll about 152 newly diagnosed patients. The trial will add the use of low molecular weight heparin (LMWH) and aspirin to manage thromboembolic events. S1313 will explore the treatment effect on carbohydrate antigen 19-9, as well as the correlation of plasma hyaluronan and tumor hyaluronan with OS, PFS and ORR. ...