FDA Grants Breakthrough Designation to Tiragolumab Plus Atezolizumab for NSCLC

The FDA has granted a breakthrough therapy designation to the anti-TIGIT therapy tiragolumab for use in combination with atezolizumab (Tecentriq) in the frontline treatment of patients with metastatic non­—small cell lung cancer (NSCLC) whose tumors are PD-L1 high and do not harbor any EGFR or ALK aberrations.¹ The decision was based on data from the phase 2 CITYSCAPE trial (NCT03563716), where the doublet was found to demonstrate better efficacy than checkpoint inhibitor monotherapy in patients with chemotherapy-naïve, locally advanced or metastatic NSCLC.²

Results from the primary analysis presented during the 2020 ASCO Virtual Scientific Program showed that tiragolumab/atezolizumab, when given every 3 weeks, led to a 43% reduction in the risk of disease progression or death versus atezolizumab/placebo in the intent-to-treat (ITT) population (n = 135; stratified HR, 0.57; 95% CI, 0.37-0.90). Moreover, the doublet elicited a confirmed overall response rate (ORR) of 31% versus 16% with placebo in the ITT population per investigator assessment.

With a median follow-up of 10.9 months, the improvement in progression-free survival was maintained with a median of 5.6 months in the investigative arm and 3.9 months in the control arm (stratified HR, 0.58; 95% CI, 0.38-0.89). The updated confirmed ORR in the investigative and control arms were 37% versus 21%, respectively.

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