Roche cancer treatment granted FDA breakthrough therapy designation

Jan. 6, 2021

Roche announced that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted breakthrough therapy designation (BTD) by the U.S. 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 tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations, according to a press release from Roche.

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA. The designation is based on randomized 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-tumor activity by potentially amplifying the immune response.

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 randomized study in the anti-TIGIT field, Roche said.

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 and a 42 percent reduction in the risk of disease worsening disease or death, compared with Tecentriq alone.

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