NEW YORK – Roche said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a combination of atezolizumab (Roche's Tecentriq) plus chemotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors have PD-L1 expression greater than a percent and who have not previously received chemotherapy for metastatic disease.
Sandra Horning, Roche’s chief medical officer and head of global product development, said in a statement that the decision "marks a breakthrough in the treatment of triple-negative breast cancer.
"With today’s announcement, we hope that people living with PD-L1-positive metastatic triple-negative breast cancer in Europe will soon have a new treatment option with the Tecentriq combination," she added.
CHMP made its recommendation based on data from the Phase III IMpassion130 study, which demonstrated that atezolizumab plus nab-paclitaxel improved progression-free survival by 38 percent compared with nab-paclitaxel alone in a patient subset who tested positive for PD-L1 expression in their tumor-infiltrating immune cells. The atezolizumab combination also showed a clinically meaningful overall survival improvement of seven months versus nab-paclitaxel alone in the PD-L1-positive population, although this analysis was informal.
Based on the specificity of benefit to patients with PD-L1 expression in the trial, assessment of the biomarker is essential for identifying individuals who are likely to respond. Expression status in Impassion130 was assessed using the Ventana SP142 assay. Research into the cross-compatibility or incompatibility of different commercially available PD-L1 assays is ongoing.