The FDA designation for the Tecentriq chemo combination is for TNBC patients whose condition is unresectable locally advanced or metastatic and whose disease expresses the PD-L1 protein, as identified by PD-L1 biomarker testing.
The chemotherapy intended to be used in combination with the Roche drug is Abraxane [albumin-bound paclitaxel; nab-paclitaxel]).
Tecentriq is a monoclonal antibody which inhibits the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells.
A decision regarding approval of the combination therapy for the type of breast cancer is anticipated to be made by the FDA by 12 March 2019.
If approved, the Tecentriq chemo combination would become the first cancer immunotherapy regimen indicated for the treatment of PD-L1-positive, metastatic triple-negative breast cancer, said Roche.
Roche chief medical officer and global product development head Sandra Horning said: “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.
“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 supplemental Biologics License Application (sBLA) submitted by Roche with the FDA for the cancer immunotherapy regimen is based on data compiled from a phase 3 trial called IMpassion130 in 902 patients.
The late-stage trial studied Tecentriq and nab-paclitaxel combination in comparison to placebo in combination with nab-paclitaxel. It found the first combination to have cut down the risk of disease worsening or death or progression-free survival (PFS) to a significant extent in the intention-to treat and PD-L1 positive population with metastatic or unresectable locally advanced TNBC.
Roche has seven phase 3 trials in progress, which are studying the role of Tecentriq in TNBC, including early and advanced stages of the condition.
The cancer immunotherapy has approvals in the US, the European Union, and more than 70 countries for patients with previously treated metastatic non-squamous non-small cell lung cancer (NSCLC) and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).