Celgene’s Abraxane combo flops in phase 3 cancer trials

pharmafile | March 14, 2019 | News story | Research and Development |  Abraxane, Celgene, clinical trials, pharma, trials 

Celgene’s Abraxane, in combination gemcitabine, has failed to meet its primary endpoint in a pivotal Phase 3 trial of patients with pancreatic cancer.

Celgene’s drug failed to achieve its primary endpoint of improvement in disease-free survival in patients with surgically resected pancreatic adenocarcinoma, as confirmed by independent radiological review, compared to gemcitabine alone.

The randomised ‘apact’ study of 866 patients tested Abraxane in combination with gemcitabine against gemcitabine alone. The difference between the two treatments was not found to be significant.

“Overall survival, a secondary endpoint of the study, was improved, reaching nominal statistical significance,” a statement from Celgene said.

“The Celgene-sponsored, pivotal, Phase 3 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,” the statement said.

Celgene confirmed Abraxane’s safety profile was in line with previous clinical data. Abraxane was previously authorised as a treatment for metastatic breast cancer in 2005, and later as a treatment for non-small-cell lung cancer and late-stage pancreatic cancer.

Louis Goss