(RTTNews) – Roche (RHHBY) said that Phase III IMpassion131 study did not meet statistical significance on its primary endpoint of progression-free survival for the initial treatment of people with metastatic triple-negative breast cancer, in the PD-L1-positive population. The study evaluated Tecentriq in combination with paclitaxel, in comparison to placebo plus paclitaxel.
The data for the secondary endpoint of overall survival showed a negative trend, however, the study was not powered for the secondary endpoint of overall survival and data were immature at time of analysis.
Overall survival follow-up is planned to continue until final analysis. Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified, the company said.
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