- 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
“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
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
Biomarker analyses from the CITYSCAPE study will be presented at the IASLC 2020
Dual blockade of the TIGIT and PD-L1 pathways
TIGIT and PD-L1 are proteins that play a role in suppression of the immune system.2 Blocking both pathways simultaneously with tiragolumab and Tecentriq® (atezolizumab) has the potential to increase anti-tumour activity by enhancing the body’s immune response to cancer cells.1 Targeting multiple immune pathways in this way has the potential to build upon previous advances in cancer immunotherapy, expand into earlier stages of disease and provide new treatment options in areas of high unmet need.
About the CITYSCAPE study1
CITYSCAPE is a global phase II, randomised and blinded study evaluating tiragolumab plus Tecentriq® (atezolizumab) compared with Tecentriq alone in 135 patients with first-line PD-L1-positive, locally advanced unresectable or metastatic non-small cell lung cancer. Patients were randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until progressive disease or loss of clinical benefit. Co-primary endpoints are overall response rate and progression-free survival. Secondary endpoints include safety and overall survival.
About tiragolumab
Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells.2,3 Tiragolumab works as an immune amplifier, by potentially enhancing the body’s immune response.1 By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the body’s immune response.4 Blockade of TIGIT and PD-L1 may synergistically enable the re-activation of T cells and enhance NK cell anti-tumour activity.2,5,6
About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.
Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer, small cell lung cancer, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.
About
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development,
In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq® (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm
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References
[1] Rodriguez-Abreu, D et al. CITYSCAPE: Primary Analysis of a Randomized, Double-Blind, Phase II Study of the Anti-TIGIT Antibody Tiragolumab plus Atezolizumab versus Placebo plus Atezolizumab as 1L Treatment in Patients with PD-L1-Selected NSCLC. Presented at: ASCO 2020 Virtual Scientific Program; 2020
[2] Johnston RJ, Comps-Agrar L, Hackney J, et al. Cancer Cell. 2014;26(6):923-937.
[3] Yu X, Harden K, Gonzalez LC, et al. Nat Immunol. 2009;10(1):48-57.
[4]
[5] Stanietsky N, Simic H, Arapovic J, et al.
[6] Kurtulus S, Sakuishi K, Ngiow SF, et al. J Clin Invest. 2015;125(11):4053-4062.
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