The US FDA’s break through designation is based on data from the Phase 2 CITYSCAPE trial of tiragolumab plus tecentriq
Roche’s tiragolumab plus tecentriq granted FDA BTD. (Credit: F. Hoffmann-La Roche Ltd.)
Roche has secured the US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) for its novel cancer immunotherapy tiragolumab, in combination with Tecentriq (atezolizumab) to treat a type of non-small cell lung cancer (NSCLC).
Tiragolumab is designed to bind with TIGIT, an immune receptor present on some T cells and Natural Killer Cells, and is the first anti-TIGIT therapy to receive FDA BTD.
The US regulatory agency indicated tiragolumab plus tecentriq combination to treat metastatic NSCLC with high PD-L1 expression, no EGFR or ALK genomic tumour aberrations.
Roche chief medical officer and global product development head 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.”
The FDA granted break through designation based on data from the Phase 2 CITYSCAPE trial, a randomised, blinded study that evaluated tiragolumab plus tecentriq compared with tecentriq alone, in 135 patients with PD-L1-positive metastatic NSCLC.
The company said that the data from CITYSCAPE demonstrated that targeting both immune inhibitory receptors, TIGIT and PD-L1 would enhance the anti-tumour activity.
Also, the drug combination has showed positive efficacy and safety results in PD-L1-positive metastatic NSCLC, in the Phase 2 CITYSCAPE trial.
In the clinical study, the combination treatment improved the overall response rate and reduced the risk of disease worsening or death (progression free survival (PFS)) by 42%, when compared to tecentriq alone.
Treatment using tiragolumab plus tecentriq was well-tolerated, and showed similar rates of all Grade 3 or more all-cause adverse events, compared with tecentriq alone.
Furthermore, an exploratory analysis in people with high levels of PD-L1 showed a clinically meaningful ORR compared to tecentriq alone, and median PFS was not reached.