Roche/Genentech’s new drug Tecentriq (atezolizumab) wins FDA priority review as a part of the regimen for the treatment of tough-to-treat Triple Negative Breast Cancer (TNBC). The drug will be used in combination with Celgene chemo med Abraxane (nab-paclitaxel) in previously untreated patients whose tumors express biomarker PD-L1.
A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
Triple-negative breast cancer is the term used to describe breast cancers that lack estrogen- and progesterone-receptor expression and do not overexpress human epidermal growth factor receptor 2 (HER2). It is more aggressive and harder to treat, it is also more likely to spread and recur. Approximately 15% of breast cancers are triple-negative based on the results of diagnostic tests.
The company’s supplemental Biologics License Application (sBLA) is based on the results of phase III IMpassion130 study, involving 902 patients with advanced breast cancer. The results demonstrated that Tecentriq plus nab-paclitaxel as an initial (first-line) treatment for unresectable locally advanced or metastatic TNBC increased the median progression-free survival (PFS) to 7.2 months instead of 5.0 months as compared to nab-paclitaxel alone group. In a subgroup analysis of PD-L1-positive population, the median survival was further increased to 7.5 months vs. 5.0 months.
The drug combination improved clinically meaningful overall survival in the PD-L1-positive population (25.0 months vs. 15.5 months). The safety profile of the drug combination was as per that reported for individual drugs. Currently, Genentech has seven ongoing phase III studies investigating Tecentriq in patients who are in various stages of TNBC.
The results of the study were presented at the European Society for Medical Oncology (ESMO) Congress and published in the October issue of New England Journal of Medicine.
“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, M.D., 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.”
It is expected that FDA will give its decision on approval by March 12, 2019. If approved, this will be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic TNBC.
