Roche gets FDA breakthrough therapy status for tiragolumab plus Tecentriq

Roche has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for tiragolumab plus Tecentriq (atezolizumab) to treat PD-L1-high non-small cell lung cancer (NSCLC).

The breakthrough therapy designation allows the combination therapy as a first-line treatment for people with metastatic NSCLC whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations.

Tiragolumab is a monoclonal antibody and novel cancer immunotherapy designed to bind to TIGIT, a protein receptor on immune cells. Tecentriq is a monoclonal antibody designed to bind with a protein known as PD-L1 to restricts its interactions with both PD-1 and B7.1 receptors.

The FDA has granted designation for combination therapy based on randomised data from the phase II CITYSCAPE trial.

The global phase II, randomised and blinded study compared tiragolumab plus Tecentriq against   Tecentriq alone in 135 patients with first-line PD-L1-positive, locally advanced unresectable or metastatic NSCLC.

Roche has randomised patients in 1:1 ratio to secure either tiragolumab plus Tecentriq or placebo plus Tecentriq, until progressive disease or loss of clinical benefit.

Overall response rate and progression-free survival are the co-primary endpoints, while secondary endpoints include safety and overall survival.

According to the company, the combination showed an improvement in the overall response rate and a 42% reduction in the risk of disease worsening or death compared with Tecentriq alone in the phase II CITYSCAPE trial.

Roche chief medical officer and global product development head Dr Levi Garraway said: “We have been researching TIGIT as a novel cancer immunotherapy target for almost ten 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.

“We look forward to advancing our tiragolumab development programme, which includes chemotherapy-free combinations and trials in early stages of disease across multiple cancer types with high unmet need.”

In September last year, Roche secured FDA approval for its Gavreto (pralsetinib) to treat adults with metastatic rearranged during transfection (RET) fusion-positive NSCLC as detected by an FDA approved test.