While the primary endpoint of disease-free survival was not met, Celgene said overall survival, which was a secondary endpoint, was improved by the combination treatment.
Celgene’s Abraxane failed to hit endpoints of improving disease-free survival in a late-stage study of pancreatic cancer patients.
On Tuesday, Celgene said Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with the chemotherapy medication gemcitabine, failed to hit the mark as a potential treatment following surgical resection (adjuvant treatment) in patients with pancreatic cancer. The two drugs were being tested as part of the Phase III apact did not meet its primary endpoint, compared to gemcitabine alone, Celgene said. The data was confirmed by an independent radiological review.
While the primary endpoint of disease-free survival was not met, Celgene said overall survival, which was a secondary endpoint, was improved by the combination treatment. Overall survival reached nominal statistical significance in comparison to gemcitabine alone, Celgene said.
Data from the apact study will be submitted to a future medical conference. Celgene said Abraxane’s safety profile remained consistent with previously reported studies. While the study failed to hit the mark for its primary endpoint, Celgene noted that Abraxane is being studied in more than 130 pancreatic cancer studies in combination with more than 50 novel agents.
Despite some advances in treating pancreatic cancer, patients still have a low survival prognosis due to the complex nature of the disease and lack of symptoms until the disease has progressed. Celgene noted that there remains a high unmet medical need for more effective adjuvant therapies.
While Abraxane did not hit the mark in the apact study, Celgene noted that Genentech, a Roche company, announced the accelerated approval of Tecentriq in combination with Abraxane for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-approved test. The combination treatment won approval based on progression-free survival results from the Phase III Impassion130 study. This combination is the first cancer immunotherapy regimen approved for breast cancer, Celgene said.
Approximately 10-20 percent of breast cancers are triple negative breast cancer. TNBC is an aggressive form of the disease with a high unmet need. It can be more difficult to treat because it is not sensitive to hormone therapy or medicines that target HER2.
The approval of Abraxane and Tecentriq marks the second approval from the U.S. Food and Drug Administration of a PD-1/PD-L1 antibody in combination with Abraxane.
Abraxane continues to be studied with immunotherapy agents as a combination partner across a range of solid tumors,” Alise Reicin, president of global clinical development at Celgene said in a statement.
