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Halozyme Presents Stage One Efficacy And Safety Analysis Of Phase 2 Clinical Study In Metastatic Pancreatic Cancer Patients Treated With PEGPH20

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Clinical Data This final analysis of secondary and exploratory endpoints was conducted using the Ventana companion diagnostic to retrospectively identify high levels of hyaluronan (HA). The key results based on a February 2016 data cut-off showed in the HA-high patient population:
  • Median progression-free survival (PFS) was 9.2 months in the PAG arm versus 6.0 months in the AG arm, hazard ratio (HR) with a 95 percent confidence interval (CI): 0.46 (0.15, 1.40);
  • Overall response rate (ORR) of 50 percent, including one complete response in the PAG arm versus 33 percent and all partial responses in the AG arm;
  • Median duration of response (DoR) of 8.1 months in the PAG arm versus 3.7 months in the AG arm;
  • The exploratory analysis of median overall survival (OS) was similar between the treatment arms -- 11.8 months vs. 10.9 months in the PAG vs. AG arms respectively. Factors potentially having an impact on these results include less aggressive disease among patients in the AG arm and a greater than 40 percent discontinuation rate of PEGPH20 treatment at the time of the clinical hold, resulting in all patients receiving AG alone in both arms;
  • The rate of thromboembolic (TE) events reduced from 43 percent to 9 percent in the PAG arm and from 25 percent to 6 percent in the AG arm with the introduction of prophylaxis with low molecular weight heparin (enoxaparin) from Stage One to Stage Two of the study.
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Catalyst Date
Occurred on:
Jun 04, 2016
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Related Keywords Pegph20, Metastatic Pancreatic Cancer, Phase 3 Halo 301 Clinical Study, Halo 109-202, Nab-paclitaxel, Abraxane, Gemcitabine, Pag Arm