FDA Grants Priority Review to Atezolizumab Plus Chemotherapy in Triple-Negative Breast Cancer
Posted: Friday, November 16, 2018
The U.S. Food and Drug Administration (FDA) has granted Priority Review for atezolizumab (Tecentriq) plus chemotherapy (nab-paclitaxel) in the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer in patients whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing.
This review is based on data from the phase III IMpassion130 study (ClinicalTrials.gov identifier NCT02425891), which was presented at the European Society for Medical Oncology (ESMO) 2018 Congress, published in The New England Journal of Medicine, and covered by JNCCN 360. These results demonstrate that this combination therapy in the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer significantly reduced the risk of disease progression or death compared with nab-paclitaxel alone. At an interim analysis, statistical significance was not met for overall survival in the intention-to-treat population, but the combination showed a clinically meaningful overall survival improvement in the PD-L1–positive population (25.0 months vs. 15.5 months, respectively). Due to the hierarchical statistical design, results in the PD-L1–positive population were not formally tested for statistical significance. Follow-up will continue until the next planned analysis.
Safety in the combination therapy arm appeared consistent with the known safety profiles of the individual treatments, with no new safety signals identified. Serious adverse events were reported in 23% of patients who received atezolizumab plus nab-paclitaxel compared with 18% of those who received nab-paclitaxel alone.
