Tiragolumab Combination Treatment Granted Breakthrough Therapy Designation in NSCLC
Posted: Tuesday, January 12, 2021
On January 5, the U.S. Food and Drug Administration (FDA) granted the immunotherapy tiragolumab Breakthrough Therapy designation in combination with atezolizumab in the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. Tiragolumab is a monoclonal antibody designed to bind to the protein receptor TIGIT on immune cells.
The designation was based on data from the phase II CITYSCAPE trial. The clinical trial enrolled a total of 135 patients with first-line PD-L1–positive, locally advanced unresectable or metastatic NSCLC. Patients were randomly selected to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab until progressive disease or loss of clinical benefit.
The results showed a higher overall response rate with the combination therapy versus atezolizumab alone (37% vs. 21%). In addition, there was a 42% improvement in progression-free survival with the combination therapy. An exploratory analysis in patients with high levels of PD-L1 showed a clinically meaningful overall response rate with tiragolumab plus atezolizumab versus atezolizumab alone (66% vs. 24%). The median progression-free survival was not reached in comparison with 4.11 months with atezolizumab alone (hazard ratio = 0.30; 95% confidence interval = 0.15–0.61). The combination therapy was associated with similar rates of grade 3 or more all-cause adverse events compared with atezolizumab alone (48% vs. 44%).