Roche's anti-TIGIT antibody tiragolumab has failed a second phase 3 trial, dousing expectations for the programme and its hopes of finding a companion to its cancer immunotherapy blockbuster . 2009;10(1):48-57. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. Tiragolumab is under investigation in clinical trial NCT04513925 . The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. [3] Yu X, Harden K, Gonzalez LC, et al. 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. The information presented should not be construed as a recommendation for use. As the industry strengthens its focus on patient centricity, Direct-to . 1,2 Once bound to TIGIT, tiragolumab may restore anti-tumor immunity, thereby complementing PD-L1 inhibition, as shown in preclinical models. The HCV RNA test is required only for patients who have a positive HCV antibody test, Patients who have a known, recent Epstein-Barr virus (EBV) infection or known history of chronic, active infection are not eligible, Patients who have history of or active human immunodeficiency virus (HIV) are not eligible except patients who are stable on anti-retroviral therapy, have a CD4 count >= 200/uL, and have an undetectable viral load, Patients who have significant cardiovascular disease (such as New York Heart Association class III or IV congestive heart failure, myocardial infarction, or cerebrovascular accident) within 3 months prior to study enrollment, unstable arrhythmia, or unstable angina are not eligible, Patients who have a major surgical procedure, other than for diagnosis, within 4 weeks prior to study enrollment, or the anticipation of the need for a major surgical procedure during the study are not eligible, Patients who have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or known active pneumonitis are not eligible. Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. 2015;125(11):4053-4062. 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. 2019;11(6):877. are open and Earnings Presentation. Sanchez-Correa B, Valhondo I, Hassouneh F, et al. GAITHERSBURG, Md. 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. investigating tiragolumab, 3 are phase 1 (3 open), 4 are phase 1/phase 2 (4 open), 6 are phase 2 (6 open), and 4 are phase 3 (4 open). Tiragolumab alone or in combination with the PD-L1 inhibitor Atezolizumab has effects on solid cancers. 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. March 30, 2022. To estimate the PFS (progression free survival), OS (overall survival), and duration of response of combination tiragolumab and atezolizumab in patients with SMARCB1 or SMARCA4 deficient tumors. For adults (>= 18 years old at enrollment), hepatitis C serology testing is required to determine eligibility. Login with a username/password associated to your organization's account. 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 . 2014;26(6):923-937. Product Information: ichorbio's Tiragolumab Biosimilar is for Research Use Only (RUO) and not for therapeutic use. 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. ; 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 . TIGIT is a coinhibitory receptor that binds to PVR on APCs and tumor cells in various solid and hematologic tumors.1-3 TIGIT dampens the immune response by competing with its costimulatory counterpart, CD226, for binding to PVR.1,2 Once bound to TIGIT, tiragolumab may restore anti-tumor immunity, thereby complementing PD-L1 inhibition, as shown in preclinical models.1 TIGIT was identified at Genentech.2,4, Targeting TIGIT may enhance Tefffunction.1, Targeting TIGIT may counter T reg-mediated immune suppression.6. To assess changes in circulating and tumoral immune markers in patients treated with this combination therapy and correlate to response when feasible. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age. Alone, the drug led to stable disease in four of 24 patients; together, tiragolumab plus atezolizumab elicited responses in three of 49 patientsincluding a partial response in head and neck squamous cellcarcinoma and partial and complete responses in NSCLC. 2005;6(4):319-331. But numerical signs of benefit among certain patients with metastatic non-small cell lung cancer suggest that TIGIT . and hasn't got worse following chemoradiotherapy. Final gross price and currency may vary according to local VAT and billing address. Target: TIGIT. 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). You can read more about the curation process here. This compound and its use are investigational and have not been approved by the US Food and Drug Administration. Note: Neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment. All trademarks used or mentioned in this release are protected by law. P/0186/2020: EMA decision of 13 May 2020 on the granting of a product specific waiver for tiragolumab (EMEA-002721-PIP01-19) (PDF/220.72 KB) 1 TIGIT was identified . 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 persons immune system combats cancer more effectively. Results showed that patients on the drug combination are living longer than those given Tecentriq and a placebo. Roche's (RHHBY) (RHHBF) new potential immunotherapy tiragolumab failed a second late stage study, this time in non-small cell lung cancer ((NSCLC)). If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely. Why Should I Register and Submit Results? Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05286801. . Median (min, max) duration of response among patients in Part B with partial or complete response to combination therapy for tiragolumab and atezolizumab stratified by disease cohort. 1-3 TIGIT dampens the immune response by competing with its costimulatory counterpart, CD226, for binding to PVR. II. To evaluate the safety of tiragolumab as monotherapy in pediatric patients (<18 years) with SMARCB1 or SMARCA4 deficient tumors. 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). Cancer Cell. These findings . To assess the association of response rate to the molecular subtypes of rhabdoid/atypical teratoid rhabdoid tumor (ATRT).
Cancers (Basel). ClinicalTrials.gov Identifier: NCT05286801, Interventional
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Adis is an information provider. 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. . He and his colleagues hypothesized tiragolumab may synergize with other immunotherapies to amplify an anti-tumor response. After completion of study treatment, patients are followed up at months 3, 6, 9, 12, 18, 24, 36, 48, and 60, up to 5 years. Johnston RJ, Comps-Agrar L, Hackney J, et al. 2009;106(42):17858-17863. 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 . Very difficult. Please report any problems/errors associated with this data to
[email protected]. Patients in the trial were under age 65 (median age 48 in the tiragolumab . APC=antigen-presenting cell; IgG1=immunoglobulin G1; NK=natural killer. A phase Ia/Ib trial tested tiragolumab in solid cancers. thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) TIGIT, a member of the Ig super family and immune inhibitory receptor, plays a key role in the suppression of T-cell proliferation and activation; it is involved in tumor cell immune evasion, and the inhibition of antiviral immune responses. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation, for 90 days after the final dose of . Tiragolumab. Improve clinical decision support with information on. Co-primary endpoints are overall response rate and progression-free survival.
Median (min, max) of the area under the serum concentration curve for the combination therapy of tiragolumab and atezolizumab in cycle 1 of Part B cohorts stratified by age group (< 18 versus >= 18 years) and disease cohort. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Atezolizumab is indicated in the first line setting for NSCLC and this study investigated the addition tiragolumab, a new antibody directed against TIGT, a new target for immune . Top Biomarker Inclusion Criteria for Open Clinical Trials Investigating Tiragolumab, mtig7192a, rg6058, anti-tigit monoclonal antibody mtig7192a, tiragolumab, tiragolumab. The other treatment is durvalumab. This includes randomised trials in metastatic NSCLC (SKYSCRAPER-01 and SKYSCRAPER-06) and small cell lung cancer (SKYSCRAPER-02), as well as exploration of tiragolumab in earlier stages, including stage III NSCLC (SKYSCRAPER-03) and locally advanced oesophageal cancer (SKYSCRAPER-07). 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. Dive Brief: A drug combination including the Roche immunotherapy tiragolumab failed a Phase 3 trial in a tough-to-treat form of lung cancer, a setback for a closely watched group of medicines that work by targeting a protein called TIGIT. Pronunciation of Tiragolumab with 3 audio pronunciations. 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). 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. The first treatment is atezolizumab and tiragolumab. Replacement therapy (e.g. 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. Tiragolumab [USAN] Synonyms. 1 The treatment regimen, therefore, did not reach its co-primary . Any grade of DTR is eligible, International normalized ratio (INR) =< 1.5 (must be performed within 7 days prior to enrollment), Serum amylase =< 1.5 x ULN (must be performed within 7 days prior to enrollment), Serum lipase =< 1.5 x ULN (must be performed within 7 days prior to enrollment), Note: can have history of hypercalcemia as long as controlled and asymptomatic, It is not known if atezolizumab or tiragolumab are present in breast milk; however, IgG immunoglobulins are found in milk. For general information, Learn About Clinical Studies. Treatment repeats every 21 days for up to 5 years in the absence of disease progression or unacceptable toxicity. The information contained in this section of the site is intended for U.S. healthcare professionals only. Click "OK" if you are a healthcare professional. It is for people with non small cell lung cancer that: is locally advanced. Treatment repeats every 21 days for up to 5 years in the absence of disease progression or unacceptable toxicity. CAS Registry Number. Roche is investigating the potential of tiragolumab in a broad development programme that builds on the benefit observed with Tecentriq while expanding into earlier stages of disease and new areas of unmet need. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Patients <18 years of age will be included in the part B cohorts only after the tiragolumab monotherapy dose has been assessed to be safe in the part A portion, Other SMARCB1 or SMARCA4 deficient tumors, Note: Documentation of the institutional IHC or molecular testing must be uploaded via the RAVE system, Part A: Patients must have either measurable or evaluable disease Part B: Patients must have either measurable disease per RECIST v1.1 for non-CNS tumors or RANO criteria for CNS tumors, Patients must have relapsed, refractory disease or newly diagnosed disease for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life, Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (Karnofsky/Lansky score of > 50). PD-L1 Expression, PD-L1 High Expression, and PD-L1 Low Expression PART B: Patients receive atezolizumab IV over 60 minutes on day 1 and tiragolumab IV over 30-90 minutes on day 1 of each cycle. The effects of atezolizumab and tiragolumab on the developing human fetus are unknown. Please remove one or more studies before adding more. 2,3 Tiragolumab works as an immune amplifier, by potentially enhancing the body's immune . Patients also undergo standard imaging scans including x-rays, CT, MRI, PET-CT, and/or FDG-PET throughout the trial. Tiragolumab has been investigated in 17 clinical 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. Choosing to participate in a study is an important personal decision. 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. Stem cell infusions (with or without total-body irradiation [TBI]): Patients must not be receiving concomitant systemic steroid medications and > 14 days must have elapsed since last dose of systemic corticosteroid with the following exceptions: For patients with solid tumors without known bone marrow involvement. 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). Secondary endpoints include safety and overall survival. https://grants.nih.gov/policy/sharing.htm. Presented at: ASCO 2020 Virtual Scientific Program; 2020 May 29-31. 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. It works in a similar way to tiragolumab to stimulate the immune system. Tiragolumab continues to be evaluated in non-small cell lung cancer and other cancer types through additional Phase III trials as planned. OX-40, CD137), Patients must not have received live/attenuated vaccine within 30 days of first dose of treatment, The use of physiologic doses of corticosteroids (5 mg/m^2/day up to 10 mg/day of prednisone equivalent) is acceptable, The use of topical, inhaled, or ophthalmic corticosteroids are acceptable, The use of acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are acceptable, Treatment with systemic immunosuppressive medication (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha [TNF-alpha] agents) must have concluded >= 14 days prior to study enrollment, Peripheral absolute neutrophil count (ANC) >= 1000/uL (must be performed within 7 days prior to enrollment), Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (must be performed within 7 days prior to enrollment), Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts above (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions).
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