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1. The latest update comes after a median of two and a half years of follow-up for the 135 patients enrolled in a Phase 2 study known as CITYSCAPE. Patients undergo standard imaging scans including x-rays, CT, MRI, PET-CT, and/or FDG-PET throughout the trial. All Activity. For part B, there is no upper age limit. Genentech's TIGIT-targeted antibody tiragolumab missed its endpoints in two late-stage lung cancer trials, raising doubts about one of the most widely studied next-generation checkpoint targets in immuno-oncology. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. By GlobalData Healthcare. Target: TIGIT. ; In an interim look at results from a study known as SKYSCRAPER-02, trial investigators found that tiragolumab, when added to chemotherapy and another Roche . [2018-07-30] [2018-08-02]. These findings demonstrate robust activity of tiragolumab in a subset of patients with advanced-stage NSCLC with a PD-L1 TPS 50%. Kurtulus S, Sakuishi K, Ngiow SF, et al. 1 TIGIT was identified . Roche will continue to examine tiragolumab in the treatment of non-small cell cancer (NSCLC) in two Phase III pivotal trials. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of therapy and at least 90 days after final dose of tiragolumab and 5 months after final dose of atezolizumab, whichever is later. Patients in the trial were under age 65 (median age 48 in the tiragolumab . As the industry strengthens its focus on patient centricity, Direct-to . MTIG7192A. There were 29 patients in each treatment arm with a PD-L1 tumor proportion score of 50% or greater. By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the body's . Patients receive atezolizumab IV over 60 minutes on day 1 and tiragolumab IV over 30-90 minutes on day 1 of each cycle. State Experimental Properties. Roche stock fell ~5% on May 11 on. SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the SMARCB1 and SMARCA4 genes, which is related to having more aggressive cancers that are harder to treat. Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Manufacturers Packagers Dosage Forms Prices Patents. is not considered a form of systemic treatment and these patients are eligible, Patients who have active immune deficiency are not eligible, Patients who have known active tuberculosis are not eligible, Patients < 18 years old at enrollment, who have known hepatitis B or C, Positive hepatitis B surface antigen (HBsAg), OR, Positive total hepatitis B core antibody (HBcAb) who have a quantitative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) >= 500 IU/mL, OR, Positive hepatitis C virus (HCV) antibody with a positive HCV ribonucleic acid (RNA) test, Note: For adults (>= 18 years old at enrollment), hepatitis B serology testing is required to determine eligibility. Information provided by (Responsible Party): This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that that has either come back (relapsed) or does not respond to therapy (refractory). Tiragolumab plus atezolizumab was well tolerated, with a safety profile generally similar to that of atezolizumab alone. Another mechanism by which cancer cells evade an immune system attack is by linking PD-L1 receptors on the tumor cell surface with PD-1 receptors on T cells. 1,2 Once bound to TIGIT, tiragolumab may restore anti-tumor immunity, thereby complementing PD-L1 inhibition, as shown in preclinical models. The Phase 3 study evaluated the tiragolumab plus Tecentriq in 534 patients with first-line PD-L1-high metastatic non-small cell lung cancer (NSCLC), compared to Tecentriq alone. Roche is the worlds largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Median (95% CI) progression-free survival for the combination therapy of tiragolumab and atezolizumab stratified by disease cohort in Part B. Avoid life-threatening adverse drug events & improve clinical decision support. The drug previously has had code names such as RG6058, RO7092284, and MTIG7192A, Tiragolumab is what is known as an "anti-TIGIT" therapy. II. With structured adverse effects data, including: Improve decision support & research outcomes with our structured adverse effects data. Tiragolumab is another precision cancer immunotherapy human monoclonal antibody that targets TIGIT, an inhibitory immune checkpoint that like PD-L1 is expressed on tumor-infiltrating immune cells like T cells and NK cells. Drugmaker Roche's novel cancer immunotherapy tiragolumab has been granted breakthrough therapy designation by the U.S. Food and Drug Administration in combination with Roche's Tecentriq in the . . Why Should I Register and Submit Results? OUTLINE: Patients are assigned to Part A or Part B. Talk with your doctor and family members or friends about deciding to join a study. The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Lung cancer is the most . [2] Johnston RJ, Comps-Agrar L, Hackney J, et al. Angiogenesis/Protein Tyrosine Kinase Angiogenesis/Protein Tyrosine Kinase https://grants.nih.gov/policy/sharing.htm. 2009;106(42):17858-17863. These findings . Discover Part 6 of the Quality Data series: Esophageal Squamous Cell Carcinoma (ESCC), Adenocarcinomas of the Gastroesophageal Junction, Advanced Unresectable or Metastatic Solid Malignancy, Squamous Cell Carcinoma of the Head and Neck (SCCHN). II. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, Medical Imaging, Positron Emission Tomography, proton magnetic resonance spectroscopic imaging, Frequency of cycle 1 dose limiting toxicities of tiragolumab as monotherapy in pediatric patients [TimeFrame:Up to 21 days], Frequency of objective response for the combination of tiragolumab and atezolizumab [TimeFrame:Up to 5 years], Frequency of cycle 1 dose limiting toxicities of the combination of tiragolumab and atezolizumab in patients < 12 years [TimeFrame:Up to 21 days], Area under the concentration curve of tiragolumab as monotherapy in cycle 1 [TimeFrame:Up to 21 days], Area under the concentration curve of combination therapy for tiragolumab and atezolizumab in cycle 1 [TimeFrame:Up to 21 days], Progression free survival (PFS) of the combination therapy for tiragolumab and atezolizumab [TimeFrame:Up to 5 years], Overall survival (OS) of the combination therapy for tiragolumab and atezolizumab [TimeFrame:Up to 5 years], Duration of response of the combination therapy for tiragolumab and atezolizumab [TimeFrame:Up to 5 years], The Part B (phase 2) cohorts will initially open concurrently with the part A but will only enroll patients at least 18 years of age. 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. Tiragolumab, alone or in combination with the PD-L1 inhibitor Atezolizumab, may be effective against multiple solid malignancies-most notably non-small cell lung cancer. For the purpose of this study, the ULN for SGPT is 45 U/L, Albumin >= 2 g/dL (must be performed within 7 days prior to enrollment), Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days, Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] v5) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflex (DTR). The 5-year average survival rate of non-small cell lung . trials Easy. Esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, and non-small cell lung carcinoma Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age. Patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors verified through institutional immunohistochemistry (IHC) or molecular confirmation of a pathologic tumor bi-allelic SMARCB1 (INI1) or SMARCA4 loss or mutation from a Clinical Laboratory Improvement Act (CLIA) certified lab with the following disease histologies: Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. F. Hoffmann-La Roche Ltd, 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 designed to block this interaction between TIGIT on immune cells and PVR on tumor cells, enabling an immune response. The designation is supported by data from a study that assessed tiragolumab plus atezolizumab in 135 chemotherapy-naive adults with locally advanced unresectable or metastatic PD-L1-selected NSCLC. Dual blockade of the TIGIT and PD-L1 pathwaysTIGIT 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 bodys 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. being investigated in are closed. 2015;125(11):4053-4062. Abbas AR, Baldwin D, Ma Y, Ouyang W, et al. For general information, Learn About Clinical Studies. Patients also undergo blood sample collection on study. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com, 05012021_MR_tiragolumab granted FDA Breakthrough Therapy Designation_en. 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., Roches Chief Medical Officer and Head of Global Product Development. Roche has suffered a setback with its much-anticipated pairing of anti-TIGIT antibody tiragolumab and PD-L1 inhibitor Tecentriq in small cell lung cancer (SCLC), in a blow to its . | Source: For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment, Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1, Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. Cancer Cell. 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. Genentech. About Roche in cancer immunotherapyRoches 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. About tiragolumabTiragolumab 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 bodys immune response.1 By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the bodys 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. Tiragolumab Biosimilar - Research Grade. 2022 Genentech USA, Inc. All rights reserved. Johnston RJ, Comps-Agrar L, Hackney J, et al. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately, Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: See Developmental Therapeutics (DVL) homepage on the Children's Oncology Group (COG) Members site for commercial and investigational agent classifications. Tecentriq (atezolizumab) carboplatin paclitaxel tiragolumab (RG6058) GO41036: a Phase Ia/Ib open-label, multicenter study evaluating the safety and pharmacokinetics of tiragolumab in combination with atezolizumab and daratumumab in patients with R/R MM (IMW 2022) N/A - Trial in Progress. Cancer Cell. The relevance of findings in preclinical studies to humans is currently being evaluated. 2,3 Tiragolumab works as an immune amplifier, by potentially enhancing the body's immune . Notified of marketing changes. This enhances the interaction of CD112 and CD155 with the costimulatory receptor CD226 (DNAX Accessory molecule-1; DNAM-1), which is expressed on immune cells, such as natural killer (NK) cells and CD8+ T-cells, and leads to CD226 dimerization and CD226-mediated signaling. You have reached the maximum number of saved studies (100). 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. Genentech's phase 3 SKYSCRAPER-01 study, which evaluated an investigational anti-TIGIT immunotherapy, tiragolumab, with atezolizumab (Tecentriq) compared with atezolizumab alone, as a first-line treatment for individuals with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC), did not meet its co-primary endpoint of progression-free survival, the company said in a . This activates the immune system to exert a T-cell-mediated immune response against cancer cells. A phase Ia/Ib trial tested tiragolumab in solid cancers. This information should not be interpreted without the help of a healthcare provider. 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