The phase III IMpassion130 study has 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 announced today demonstrated that the investigational combination of atezolizumab with albumin-bound paclitaxel 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, compared to albumin-bound paclitaxel alone.
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 combination arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.
IMpassion130 is a phase III multicenter, randomized, double-blind study evaluating the efficacy, safety, and pharmacokinetics of atezolizumab and paclitaxel compared with placebo combination in people with locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer.
The study enrolled 902 people who were randomized equally (1:1).
The co-primary endpoints were progression-free survival (PFS) per investigator assessment (RECIST 1.1) and overall survival (OS). PFS and OS were assessed in all randomized participants [intention-to-treat (ITT)] and in those whose disease expressed the PD-L1 protein.
Secondary endpoints included objective response rate, duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.
“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 the atezolizumab combination 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 albumin-bound paclitaxel as a preferred chemotherapy partner for immunotherapy combinations.”
Results will be presented at an upcoming medical meeting.