FDA grants priority review for Atezolizumab, a cancer immunotherapy, in locally advanced or metastatic non-small cell lung cancer whose disease expresses the protein PD-L1
The FDA ( Food and Drug Administration ) has accepted the Biologics License Application ( BLA ) and granted Priority Review for Atezolizumab ( anti-PDL1; MPDL3280A ) for the treatment of people with locally advanced or metastatic non-small cell lung cancer ( NSCLC ) whose disease expresses the protein PD-L1 ( programmed death ligand-1 ), as determined by an FDA-approved test, and who have progressed on or after Platinum-containing chemotherapy.
Locally advanced or metastatic non-small cell lung cancer with PD-L1 expression
Atezolizumab was granted Breakthrough Therapy designation by the FDA in February 2015 for the treatment of people whose NSCLC expresses PD-L1 and whose disease progressed during or after standard treatments ( e.g., Platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease ).
The BLA submission for Atezolizumab is based on results from clinical trials including the phase II BIRCH study, and the FDA will make a decision on approval by October 19, 2016.
A Premarket Application ( PMA ) is also under review by the FDA for a companion immunohistochemistry ( IHC ) test developed by Roche Tissue Diagnostics.
BIRCH is an open-label, multicenter, single-arm phase II study that evaluated the safety and efficacy of Atezolizumab in 667 people with locally advanced or metastatic NSCLC whose disease expressed PD-L1.
PD-L1 expression was assessed for both tumor cells and tumor-infiltrating immune cells with an investigational IHC test based on the SP142 antibody.
People in the study received a 1200-mg intravenous dose of Atezolizumab every three weeks.
The primary endpoint of the study was objective response rate ( ORR ) as assessed by an independent review facility ( IRF ) using RECIST v1.1. Secondary endpoints included duration of response ( DOR ), overall survival, progression-free survival and safety.
Non-small cell lung cancer
Lung cancer is the leading cause of cancer death globally. Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.
Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.
Atezolizumab, an investigational monoclonal antibody against PD-L1 ( programmed death ligand-1 ), is designed to bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, Atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells. ( Xagena )
Source: Roche, 2016