Genentech has reported positive results from the IMpassion130 study after the trial met its co-primary endpoint of progression free survival (PFS).
IMpassion130 is a Phase III multicentre, randomised, double-blind trial evaluating the efficacy, safety, and pharmacokinetics of Tecentriq and nab-paclitaxel compared with placebo in combination with nab-paclitaxel to treat people with locally advanced or metastatic triple negative breast cancer (TNBC).
The trial enrolled 902 TNBC patients who have not received prior systemic therapy for metastatic breast cancer (mBC). The patients were randomised equally in a 1:1 ratio.
The co-primary endpoints of the IMpassion130 study were PFS per investigator assessment (RECIST 1.1) and overall survival (OS).
Secondary endpoints of the trial included objective response rate, duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.
The newly published results have demonstrated that the combination of Tecentriq (atezolizumab) plus chemotherapy, which was given as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in the metastatic or unresectable locally advanced TNBC patients.
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The trial also reported no new safety signals in the Tecentriq plus nab-paclitaxel arm.
Genentech chief medical officer and Global Product Development head Sandra Horning said: “IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options.
“Highly encouraged by these results, we plan to submit to authorities globally with the aim of bringing this combination to people with triple negative breast cancer as soon as possible.”
IMpassion130 is the third of the seven Phase III studies currently being carried out by Genentech for investigating Tecentriq in TNBC.
Tecentriq is a monoclonal antibody designed to PD-L1 protein expressed on tumour cells and tumour-infiltrating immune cells, thereby blocking its interactions with both PD-1 and B7.1 receptors.