Genentech’s cancer drug gets Breakthrough Therapy Designation from FDA

pharmafile | January 5, 2021 | News story | Manufacturing and Production Cancer, Genentech 

Genentech has announced that tiragolumab, a novel cancer immunotherapy designed to bind to T cell immunoreceptor with Ig and ITIM domains (TIGIT), has been granted Breakthrough Therapy Designation (BTD) by the 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.

The designation of Tiragolumab, the first anti-TIGIT molecule to be granted BTD from the FDA, 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.

BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions, with preliminary evidence indicating that they may demonstrate a substantial improvement on current therapies. Genentech’s latest announcement marks the 37th BTD for their 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.

Full results from CITYSCAPE showed that at an average of 10.9 months follow-up, 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.

Dr Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, said: “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.

“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.”

Darcy Jimenez

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