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. All trademarks used or mentioned in this release are protected by law. The other treatment is durvalumab. 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 . Free Case Study. Patients with indwelling catheters (e.g., PleurX) are allowed, Patients who have an uncontrolled infection are not eligible, Patients who have received a prior solid organ transplantation are not eligible, Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible. Patients also undergo blood sample collection on study. 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.. Residents only. Roche is the worlds largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. For part A, patients must be <18 years old at enrollment. J Clin Invest. PD-L1 Expression, PD-L1 High Expression, and PD-L1 Low Expression are the most frequent biomarker . Of the Abstinence is an acceptable method of birth control. 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. Biomarker analyses from the CITYSCAPE study will be presented at the IASLC 2020 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, taking place from 28-31 January 2021: Efficacy of Tiragolumab + Atezolizumab in PD-L1 IHC and TIGIT Subgroups in the Phase II CITYSCAPE Study in First-Line NSCLC. and hasn't got worse following chemoradiotherapy. The phase 3 trial, dubbed SKYSCRAPER-02, evaluated the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial . 1-3 TIGIT dampens the immune response by competing with its costimulatory counterpart, CD226, for binding to PVR. (Part A) II. 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. 2. 2022 Genentech USA, Inc. All rights reserved. Registry Numbers. Tiragolumab has been investigated in 17 clinical Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomised data from the phase II CITYSCAPE trial. Efficacy and safety have not been established. IP authentication when working within your organization's network. Product Information: ichorbio's Tiragolumab Biosimilar is for Research Use Only (RUO) and not for therapeutic use. Upon administration, tiragolumab binds to TIGIT expressed on various immune cells, particularly on tumor-infiltrating T-lymphocytes (TILs), thereby preventing the interaction of TIGIT with its ligands CD112 (nectin-2; poliovirus receptor related-2; PVRL2) and CD155 (poliovirus receptor; PVR; nectin-like 5; NECL-5). Lung cancer is the most . and SUZHOU, China, Sept. 20, 2022 /PRNewswire/ -- *Sirnaomics Ltd. *(the "*Company*" or "*Sirnaomics*", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that it will present the latest developments on delivery of novel RNAi therapies for cancer, and its GalAhead platform and programs, at the 2^nd . Easy. References [1] Rodriguez-Abreu, D et al. A creatinine based on age/gender as follows (must be performed within 7 days prior to enrollment): Bilirubin (sum of conjugated + unconjugated or total) =< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment). Pregnancy tests must be obtained in girls who are post-menarchal. Difficult. To evaluate antitumor activity of the combination of tiragolumab and atezolizumab as assessed by objective response rate in patients with SMARCB1 or SMARCA4 deficient tumors per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 (for non-central nervous system [CNS] tumors) or Response Assessment in Neuro-Oncology Criteria (RANO) (for CNS tumors). PART A: Patients receive tiragolumab intravenously (IV) over 30-90 minutes on day 1 of each cycle and atezolizumab IV over 60 minutes on day 1 of each cycle starting in cycle 2. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05286801. It works in a similar way to tiragolumab to stimulate the immune system. About the CITYSCAPE study1CITYSCAPE 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. Presented at: ASCO 2020 Virtual Scientific Program; 2020 May 29-31. Atezolizumab is another type of immunotherapy drug. Tiragolumab. can't be removed by surgery. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). Blocking this protein helps the immune system to find and fight cancer cells. 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 . Results showed that patients on the drug combination are living longer than those given Tecentriq and a placebo. January 05, 2021 01:00 ET Moderate. Tiragolumab plus atezolizumab was well tolerated, with a safety profile generally similar to that of atezolizumab alone. Tiragolumab alone or in combination with the PD-L1 inhibitor Atezolizumab has effects on solid cancers. 2,3 Tiragolumab works as an immune amplifier, by potentially enhancing the body's immune . Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Tiragolumab Biosimilar - Research Grade. All patients had a baseline ECOG performance status of 0 or 1, more than 60% in each arm were men, more than 70% were White, nearly 20% had brain metastases, and nearly 40% had liver metastasis. Treatment repeats every 21 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Synonyms and mappings are based on the best public information available at the time of publication. Please report any problems/errors associated with this data to FDA-SRS@fda.hhs.gov. Cancer Cell. Pronunciation of Tiragolumab with 3 audio pronunciations. 1,2 Once bound to TIGIT, tiragolumab may restore anti-tumor immunity, thereby complementing PD-L1 inhibition, as shown in preclinical Seksyen 10, Kawasan Perusahaan Bangi, 43650 Bandar Baru Bangi, Selangor, Malaysia. Watch. Esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, and non-small cell lung carcinoma Patients with known, untreated CNS metastases will be excluded with the following exceptions: Patients >= 18 years old at enrollment with: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The absence of an interaction does not necessarily mean no interactions exist. Study Rundown: This study explored the impact of tiragolumab with atezolizumab as compared to placebo with atezolizumab a first-line treatment for non-small-cell lung cancer (NSCLC) that is unresectable or metastatic. APC=antigen-presenting cell; IgG1=immunoglobulin G1; NK=natural killer. Secondary endpoints include safety and overall survival. To assess changes in circulating and tumoral immune markers in patients treated with this combination therapy and correlate to response when feasible. Major changes. II. thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) 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. There were 29 patients in each treatment arm with a PD-L1 tumor proportion score of 50% or greater. Nat Immunol. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during therapy and for at least 5 months after the last dose of atezolizumab and 90 days after the last dose of tiragolumab, whichever is later, Investigational drugs: Patients who are currently receiving another investigational drug are not eligible, Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible, Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, and thalidomide) during study treatment because these agents could potentially alter the efficacy and safety of study treatments would not be eligible, Patients must not have a known hypersensitivity to any component of tiragolumab or atezolizumab injection, History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins, Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or tiragolumab formulation, Patients who have undergone allogeneic bone marrow or stem cell transplant are not eligible, Patients with a history of CNS metastases that have been previously treated may enroll if sequential imaging shows no evidence for active disease in the CNS, Patients must not have active autoimmune disease that has required systemic treatment in the past 12 months, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. 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