The Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) that randomised 861 metastatic pancreatic cancer patients with either Abraxane along with gemcitabine or gemcitabine alone met its primary endpoint of overall survival.
Key secondary endpoints of the open-label study included evaluation of progression-free survival, objective tumor response and the safety and tolerability of the combination in the patient population.
A similar safety profile of Abraxane (paclitaxel protein-bound particles for injectable suspension) in combination with gemcitabine as compared to Abraxane clinical trials in pancreatic cancer was observed.
Company is planning to submit dossiers for registration in the US, Europe and other markets, considering the MPACT study results as the base.