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Roche’s tiragolumab plus Tecentriq combo wins FDA breakthrough therapy designation

Swiss pharma is aiming for approval in first-line NSCLC

Swiss pharma company Roche has scored a breakthrough therapy designation (BTD) from the US Food and Drug Administration for its combination of its investigational TIGIT blocker tiragolumab and its PD-L1 inhibitor Tecentriq (atezolizumab).

The BTD covers the combination treatment in the first-line setting for people with metastatic non-small cell lung cancer (NSCLC), whose tumours have high PD-L1 expression and no EGFR or ALK mutations.

According to Roche, tiragolumab is the first anti-TIGIT molecule to win a BTD from the FDA. TGIT is a protein receptor on immune cell that plays a role in the suppression of the immune system.

Tiragolumab, by binding to TIGIT, works as an immune amplifier and potentially enhances the body’s immune response against tumours.

In combination with Tecentriq, which blocks PD-L1, it is believed that the dual action of both treatments could enable the re-activation of T cells as well as enhance NK cell anti-tumour activity.

The BTD is based on data from Roche’s phase 2 CITYSCAPE trial, recently presented at the 2020 American Society of Clinical Oncology virtual meeting.

Results from this study showed that, after an average follow-up of 10.9 months, the combination treatment improved the overall response rate compared to Tecentriq alone (37% and 21% respectively).

Tiragolumab plus Tecentriq also reduced the risk of disease worsening or death, or progression-free survival, by 42% compared with Tecentriq alone.

“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, chief medical officer and head of Global Product Development, Roche.

“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,” he added.

The TIGIT-targeting treatment is being investigated in a number of additional trials, including further trials in NSCLC, as well as in small cell lung cancer and in earlier stage cancers – such as stage III NSCLC and locally advanced oesophageal cancer.

On top of these studies, tiragolumab is being evaluated in metastatic oesophageal squamous cancer and cervical cancer.

Article by
Lucy Parsons

6th January 2021

From: Regulatory

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