Top-line results announced from the international Phase 3 study evaluating adjuvant therapy with ABRAXANE in combination with gemcitabine vs. gemcitabine alone for patients with surgically resected pancreatic cancer.
Celgene Corporation announced two updates 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.
Genentech, a member of the Roche Group, recently announced the accelerated approval of TECENTRIQ® (atezolizumab) 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. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). This combination is the first cancer immunotherapy regimen approved for breast cancer and is based on results from the Phase 3 IMpassion130 study, which demonstrated that the combination of TECENTRIQ plus ABRAXANE compared to ABRAXANE monotherapy, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (progression-free survival) in patients with metastatic or unresectable locally advanced triple negative breast cancer (TNBC) in the PD-L1 positive populations who had not received chemotherapy for metastatic disease.
This is the second approval from the U.S. Food and Drug Administration of a PD-1/PD-L1 antibody in combination with ABRAXANE. ABRAXANEcontinues to be studied with immunotherapy agents as a combination partner across a range of solid tumors,
said Alise Reicin, M.D., President,
Global Clinical Development for Celgene.
In addition, 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, 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.