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.

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The Company plans to discontinue further development of PEGPH20 and will focus its operations solely on its ENHANZE drug delivery technology.


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Further details regarding the organizational restructuring and strategic actions of Halozyme can be found here.