SUMMIT (dpa-AFX) - Celgene International Sàrl, a subsidiary of Celgene Corp. (CELG) announced that its phase III study of Abraxane, or 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, the company said.
In the MPACT or 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 company said it 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, the company said.
Abraxane is an albumin-bound form of paclitaxel that is manufactured using patented nab technology. Abraxane is formulated with albumin, a human protein, and is free of solvents.
In October 2012, Abraxane was approved by the U.S. Food and Drug Administration for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
The company cautioned that Abraxane should not be used in patients who have baseline neutrophil counts of < 1,500 cells/mm3. Patients who experience a severe hypersensitivity reaction to Abraxane should not be rechallenged with the drug.
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