Celgene announced that its Phase 3 study of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine (Gemzar; Lilly) in treatment-naïve patients with advanced pancreatic cancer met its primary endpoint of overall survival. Abraxane is an albumin-bound form of paclitaxel that is manufactured using patented nab technology.
The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study was an open-label, randomized, international study in which 861 metastatic pancreatic cancer patients were randomized to receive either Abraxane plus gemcitabine (125mg/m2 followed by 1000mg/m2 gemcitabine for 3 weeks followed by a week of rest) or gemcitabine alone (1000mg/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 was improvement in overall survival. Secondary endpoints included evaluation of progression-free survival, objective tumor response and the safety and tolerability of this combination in this patient population.
In the study, Abraxane in combination with gemcitabine demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine alone.
Abraxane is approved for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Abraxane is also approved 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.
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