Roche’s novel anti-TIGIT tiragolumab granted FDA Breakthrough Therapy Designation in combination with Tecentriq for PD-L1-high non-small cell lung cancer

• Tiragolumab is the first anti-TIGIT therapy to be granted Breakthrough Therapy Designation (BTD) and marks the 37th BTD for Roche’s portfolio of medicines
• BTD is based on the randomised phase II CITYSCAPE study that showed encouraging efficacy and safety with tiragolumab plus Tecentriq (atezolizumab) in people with PD-L1-positive metastatic non-small cell lung cancer
• Broad tiragolumab development programme is ongoing across various settings in different tumour types, including lung, oesophageal and cervical cancers
  
  

Basel, 5 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA), in combination with Tecentriq (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations. Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomised data from the phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumour activity by potentially amplifying the immune response.¹

“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,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions, with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies. This marks the 37th BTD for Roche’s portfolio of medicines.

Tiragolumab in combination with Tecentriq has so far shown encouraging efficacy and safety in PD-L1-positive metastatic NSCLC based on data from the phase II CITYSCAPE trial, the first randomised study in the anti-TIGIT field.¹ Full results from CITYSCAPE, presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program, showed that at an average of 10.9 months follow-up, the combination showed an improvement in the overall response rate (ORR; 37% vs. 21% with Tecentriq alone) and a 42% reduction in the risk of disease worsening or death (progression free survival; PFS) compared with Tecentriq alone.¹ An exploratory analysis in people with high levels of PD-L1 (tumour proportion score; TPS ≥ 50%) showed a clinically meaningful ORR vs. Tecentriq alone (66% vs. 24%) and median PFS was not reached (vs. 4.11 months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61).¹ The data suggest that tiragolumab plus Tecentriq was generally well-tolerated, showing similar rates of all Grade 3 or more all-cause adverse events when combining the two immunotherapies compared with Tecentriq alone (48% vs. 44%).¹