Celgene Corporation announces that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival (PFS). This is the first phase III study to demonstrate a statistically significant PFS improvement in first-line metastatic or unresectable locally advanced triple negative breast cancer (TNBC), a type of breast cancer with high unmet need.
Results demonstrated that the investigational combination of TECENTRIQ® (atezolizumab) plus ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) compared to ABRAXANE® monotherapy, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in patients with metastatic or unresectable locally advanced TNBC in the intention-to-treat (ITT) and PD-L1 positive populations. Overall survival is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis. Safety in the TECENTRIQ® plus ABRAXANE® arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.
"The IMpassion130 results are extremely encouraging for patients with this highly aggressive form of breast cancer for which there are limited options," said
Jay Backstrom
, M.D., Chief Medical Officer for Celgene. "This is the third positive Phase III study to demonstrate a clinical benefit with TECENTRIQ® plus ABRAXANE® as part of a treatment regimen; the other studies evaluated this investigational combination in non-small cell lung cancer patients. These data demonstrate the potential role of ABRAXANE® as a preferred chemotherapy partner for immunotherapy combinations."
For more info: http://ir.celgene.com/releasedetail.cfm?ReleaseID=1071755