US regulators are undertaking a priority review of Roche’s Tecentriq in combination with Abraxane for the treatment of triple-negative breast cancer.
The company is seeking approval to market the combination for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing.
The application is based on data from the Phase III IMpassion130 study, which showed that Tecentriq (atezolizumab) plus nab-paclitaxel reduced the risk of disease worsening or death compared with nab-paclitaxel alone in all randomised patients (median progression-free survival [PFS] 7.2 vs. 5.5 months, respectively) and the PD-L1-positive population (median PFS 7.5 vs 5.0 months).
Safety appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination, the firm said. Serious adverse events were reported in 23% of people who received Tecentriq plus nab-paclitaxel compared to 18% of people who received nab-paclitaxel alone.
“Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer. People need more options for this type of breast cancer, which is particularly difficult to treat,” said Sandra Horning, Roche’s chief medical officer and head of Global Product Development. “We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive metastatic triple-negative breast cancer as soon as possible.”
The FDA is expected to make a decision on approval by 12 March 2019.