Celgene Phase III Abraxane study meets primary endpoint

11th November 2012 (Last Updated November 11th, 2012 18:30)

Celgene International has reported that its Phase III study of Abraxane (paclitaxel protein-bound particles for injectable suspension) for the treatment of advanced pancreatic cancer met its primary endpoint of overall survival.

Celgene International has reported that its Phase III study of Abraxane (paclitaxel protein-bound particles for injectable suspension) for the treatment of advanced pancreatic cancer met its primary endpoint of overall survival.

Abraxane, in combination with gemcitabine, demonstrated statistically significant improvement in overall survival for patients with advanced pancreatic cancer.

The Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) randomised 861 metastatic pancreatic cancer patients with either Abraxane with gemcitabine or gemcitabine alone.

Patients were administered 125mg/m2 Abraxane followed by 1000mg/m2 gemcitabine for three weeks, followed by a week of rest.

Patients in the gemcitabine alone arm received 1000mg/m2 weekly for seven weeks, followed by a week of rest.

Both study arms underwent cycles of weekly administration for three weeks followed by one week of rest.

Improvement in overall survival is the primary endpoint, while secondary endpoints included evaluation of progression-free survival, objective tumor response and the safety and tolerability of the combination in the patient population.

The study observed a similar safety profile of Abraxane in combination with gemcitabine as compared to other Abraxane clinical trials in pancreatic cancer.

Company is planning to submit dossiers for registration in the US, Europe and other markets, taking these study results as the base.

Abraxane is an albumin-bound form of paclitaxel that is manufactured using patented nab technology.