Roche lung cancer drug combo gets US FDA breakthrough status

Roche Holding AG received the U.S. Food and Drug Administration's breakthrough therapy designation for a tiragolumab combination for treating certain people with non-small cell lung cancer.

The combination therapy, which consists of the Swiss drugmaker's cancer immunotherapy tiragolumab and blockbuster antibody drug Tecentriq, is intended for the initial treatment of NSCLC patients whose cancer has spread to another body part. These patients' tumors have a high expression of the programmed death-ligand 1 protein, or PD-L1, with no EGFR or ALK genomic tumor aberrations.

Tiragolumab is designed to bind to TIGIT, a protein receptor on immune cells.

The designation is based on data from a phase 2 clinical trial, dubbed Cityscape, in which the tiragolumab combo was found to be more effective in shrinking tumors in NSCLC patients than Tecentriq alone.

NSCLC is the most common type of lung cancer and accounts for about 85% of all cases. There were an estimated 228,820 new cases of lung cancer in the U.S. in 2020, with roughly 135,720 deaths caused by the disease.