Celgene International Sàrl, a subsidiary of Celgene Corporation today announced that its phase III study of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naïve patients with advanced pancreatic cancer met its primary endpoint of overall survival.
In the study, Abraxane in combination with gemcitabine demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine alone.
In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, a Celgene-sponsored, open-label, randomized, international study 861 metastatic pancreatic cancer patients were randomized to receive either Abraxane plus gemcitabine (125 mg/m2 followed by 1000 mg/m2 gemcitabine for 3 weeks followed by a week of rest) or gemcitabine alone (1000 mg/m2 administered weekly for 7 weeks followed by a week of rest followed by cycles of weekly administration for 3 weeks followed by one week of rest).
The primary endpoint for the study is improvement in overall survival. Secondary endpoints include evaluation of progression-free survival, objective tumor response and the safety and tolerability of this combination in this patient population.
The safety profile of Abraxane in combination with gemcitabine observed in the study is comparable with other Abraxane clinical trials in pancreatic cancer. A late-breaker placeholder abstract for this study has been submitted to the American Society of Clinical Oncology’s (ASCO) 2013 Gastrointestinal Cancers Symposium being held in San Francisco on January 24-26, 2013.
Based on the results of the MPACT study, the company plans to submit dossiers for registration in the US, Europe and other markets.
These results are from an investigational phase III study. Abraxane is not currently approved for the treatment of advanced pancreatic cancer.