Novel Therapy-Tecentriq Combo Receives Breakthrough Designation from FDA for Non-Small Cell Lung Cancer


The FDA based its decision on data that demonstrated that the novel therapy in combination with Tecentriq induced a higher overall response to therapy compared to Tecentriq alone in patients with PD-L1-positive non-small cell lung cancer.

The Food and Drug Administration (FDA) recently granted breakthrough therapy designation for tiragolumab in combination with Tecentriq (atezolizumab) for the firstline treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high PD-L1 and have no EGFR or ALK genomic aberrations, according to the novel agent’s manufacturer, Roche.

“We have been researching TIGIT as a novel cancer immunotherapy target for almost 10 years and we are pleased that the FDA has acknowledged the potential of tiragolumab to substantially improve outcomes for people with certain types of lung cancer,” said Roche’s chief medical officer and head of global product development Dr. Levi Garraway in a company-issued press release.

The breakthrough therapy designation was based on phase 2 data from the CITYSCAPE trial, which demonstrated that after an average follow-up of 10.9 months, treatment with tiragolumab plus Tecentriq was associated with a 42% reduction in the risk of disease worsening or death, compared to Tecentriq alone.

The randomized, blinded study analyzed the safety and efficacy of the combination therapy compared with Tecentriq alone among 135 patients with firstline PD-L1-positive, locally advanced unresectable or metastatic NSCLC. Measuring overall response to treatment and progression-free survival (the time from treatment to disease progression) was the main goal of the study.

After follow-up, data from the study demonstrated that the combination induced a response in 37% of patients compared to 21% in patients who received Tecentriq alone. Data from an exploratory analysis of patients with high levels of PD-L1 demonstrated that patients who received the combination had not yet reached a median PFS, compared to 4.11 months in patients who received Tecentriq alone.

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