BRIEF—Disappointing Phase III Abraxane results

US biotech Celgene has announced an update for Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound) in the treatment of metastatic triple-negative breast cancer and early stage pancreatic cancer.

The Celgene-sponsored, pivotal, Phase III apact study evaluating the investigational use of Abraxane in combination with gemcitabine following surgical resection (adjuvant treatment) in patients with pancreatic cancer did not achieve the primary endpoint of improvement in disease-free survival, as confirmed by independent radiological review, compared to gemcitabine alone.

Overall survival, a secondary endpoint of the study, was improved, reaching nominal statistical significance, with Abraxane in combination with gemcitabine compared to gemcitabine alone.

The safety profile observed in the apact study was consistent with previously reported studies of Abraxane.

Data from apact will be submitted to a future medical meeting.

Currently, there are more than 130 studies evaluating the use of Abraxane in patients with pancreatic cancer in combination with more than 50 novel agents.