Genentech, Inc issued the following announcement on July 1.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpassion130 study met its co-primary endpoint of progression free survival (PFS). Results demonstrated that the combination of TECENTRIQ® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in people with metastatic or unresectable locally advanced triple negative breast cancer (TNBC). Overall survival (OS) 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 nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Results will be presented at an upcoming medical meeting and will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
“IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “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.”
This is the third positive Phase III study that includes TECENTRIQ and nab-paclitaxel as part of a treatment regimen. Currently, Genentech has seven ongoing Phase III studies investigating TECENTRIQ in TNBC.
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