pharmafileJuly 06, 2018
Tag: Roche , Phase 3 , Tecentriq
Roche has unveiled new Phase 3 data on its immunotherapy drug Tecentriq (atezolizumab) in combination with chemotherapy (Celgene’s Abraxane) as a first-line treatment, confirming that it met its co-primary endpoint of progression-free survival (PFS) in PD-L1-positive patients with metastatic or unresectable locally advanced triple negative breast cancer (TNBC).
In 902 trial participants with locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer, Tecentriq was found to "significantly reduce" the risk of disease progression or death.
The manufacturer noted that the therapy’s effect on the other co-primary endpoint, overall survival (OS), was "encouraging" at this interim stage, and will continue to be assessed through follow-up studies.
This is the third positive Phase 3 study supporting the efficacy of Tecentriq and chemotherapy. Roche said that the data will be submitted to the FDA and EMA for regulatory consideration, and full results from the trial will be presented at an upcoming medical meeting.
"IMpassion130 is the first positive Phase 3 immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options," commented Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. "Highly encouraged by these results, we plan to submit to health authorities globally with the aim of bringing this combination to people with triple negative breast cancer as soon as possible."
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