Halozyme Therapeutics announced that the phase 3 HALO-301 study of PEGPH20 as a first-line therapy for treatment of patients with metastatic pancreatic cancer has failed to meet the primary end point of overall survival.
In the multicenter, double-blind, placebo-controlled study, patients were randomized to receive either PEGPH20 or placebo in combination with gemcitabine and nab-paclitaxel (Abraxane; Celgene). The primary end point was overall survival (OS) at approximately 24 months; secondary end points included progression free survival (PFS), objective response rate, duration of response (DOR), and the number of patients with treatment-emergent adverse events at approximately 12 months.
Results showed that PEGPH20 in combination with gemcitabine and nab-paclitaxel was not associated with an improvement in median OS compared with the placebo group (11.2 months vs 11.5 months, respectively; hazard ratio [HR] 1.00; P =.9692). Additionally, patients treated with PEGPH20 did not show improvements in DOR or PFS, despite the fact that a higher response rate was seen in the PEGPH20 treatment arm.
The Company plans to discontinue further development of PEGPH20 and will focus its operations solely on its ENHANZE drug delivery technology.
Further details regarding the organizational restructuring and strategic actions of Halozyme can be found here.