A Phase II Study of Immunotherapies (Tiragolumab and Atezolizumab) in Combination With Stereotactic Body Radiation Radiotherapy in Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)

Background:
Metastatic colorectal cancer (mCRC) is cancer that has spread beyond the colon and rectum. Most people with mCRC die within 5 years. New immune-based treatments are making progress with some types of colon cancer. But these treatments do little for people with a type of cancer that is microsatellite stable (MSS). MSS is a specific cancer biomarker. Better treatments are needed.
Objective:
To test 2 drugs (tiragolumab and atezolizumab) combined with radiation therapy in people with MSS mCRC.
Eligibility:
People aged 18 years and older with MSS mCRC.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and a test of their heart function. They will provide a tissue sample from their tumor; if one is not already available, a new sample will be taken. Their ability to perform normal tasks will be assessed.
Tiragolumab and atezolizumab are both administered through a tube attached to a needle inserted into a vein. Participants will receive both drugs on day 1 of 3-week treatment cycles. Each study visit should last about 8 hours.
Participants will receive radiation therapy on days 1, 3, and 5 of cycle 1 only.
Blood samples and rectal swabs will be collected on day 1 of every cycle.
Imaging scans will be repeated every 9 weeks. Additional tumor samples may be taken during treatment.
Treatment will continue for up to 2 years.
Participants will have a follow-up visit 1 month after treatment ends. Follow-up visits will continue every 3 months for 1 more year.

Start Date02 Dec 2024

Sponsor / Collaborator

National Cancer Institute

NCT06331598 / RecruitingPhase 2

A Phase II, Open Label, Randomized, Non-Comparative Cohorts Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors With Resectable Disease With Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H)

This study is being conducted to evaluate efficacy parameters (disease free survival [DFS] and overall survival [OS]) of atezolizumab and atezolizumab in combination with tiragolumab in TMB-H or MSI-H as adjuvant treatment after standard radical intended treatment in participants with intermediate-high risk of recurrence.

Start Date30 Nov 2024

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

NCT06342037 / RecruitingPhase 2IIT

NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial

This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer.

Start Date12 Jun 2024

Sponsor / Collaborator

Netherlands Cancer Insitute

[+1]

100 Clinical Results associated with Tiragolumab

100 Translational Medicine associated with Tiragolumab

100 Patents (Medical) associated with Tiragolumab

Literatures (Medical) associated with Tiragolumab

19 Sep 2024·EUROPEAN JOURNAL OF PEDIATRICS

Development and characterisation of [¹⁸F]TTDP, a novel T cell immunoglobulin and ITIM domain tracer, in humanised mice and non-human primates.

Article

Author: Zhao, Fangyu ; Wang, Tianyi ; Yu, Hong ; Zhu, Mengyuan ; Li, Xinyu ; Wu, Yongyi ; Guan, Zhengqi ; Han, Zhaoguo ; Sun, Ying ; Wang, Yueqi ; Li, Xiaoqian ; Hu, Xinxin ; Wang, Hongbin ; Sun, Xilin ; Zhang, Duoyi ; A, Rong ; Wang, Jiannan ; Chen, Wei ; Wang, Jing ; Li, Xiaona ; Liu, Yang

PURPOSE:

The T cell immunoglobulin and ITIM domain (TIGIT) blockade immunotherapy response is directly associated with individual differences of TIGIT expression on tumour-infiltrating lymphocytes (TILs) in tumour immune microenvironment (TIME) of non-small cell lung cancer (NSCLC). Here, we developed a TIGIT-targeted PET tracer to evaluate its feasibility in predicting immunotherapy efficacy, aiming to manage NSCLC patients accurately.

METHODS:

We synthesised a ¹⁸F-labeled TIGIT-targeted D-peptide, [¹⁸F]TTDP, and investigated the specificity of [¹⁸F]TTDP both to murine TIGIT and human TIGIT by a series of in vitro and in vivo assays. [¹⁸F]TTDP PET imaging was performed in humanised immune system (HIS) mice models bearing NSCLC patient-derived xenografts (PDXs) to evaluate the predictive value of FDA-approved combination immunotherapy of atezolizumab plus tiragolumab. Lastly, rhesus macaque was applied for [¹⁸F] TTDP PET to explore the tracer's in vivo distribution and translational potential in non-human primates.

RESULTS:

[¹⁸F]TTDP showed high specificity for both murine TIGIT and human TIGIT in vitro and in vivo. The HIS NSCLC PDX platform was successfully established for [¹⁸F]TTDP PET imaging, and tumour uptake of [¹⁸F]TTDP was significantly correlated with the TIGIT expression of TILs in the TIME. [¹⁸F]TTDP PET imaging, in predicting treatment response to the combination immunotherapy in NSCLC HIS-PDX models, showed a sensitivity of 83.33% and a specificity of 100%. In addition, [¹⁸F]TTDP PET also showed cross-species consistency of the tracer biodistribution between non-human primate and murine animals, and no adverse events were observed.

CONCLUSION:

The combined implementation of the [¹⁸F]TTDP and HIS-PDX model creates a state-of-the-art preclinical platform that will impact the identification and validation of TIGIT-targeted PET image-guided diagnosis, treatment response prediction, beneficial patient screening, novel immunotherapies, and ultimately the outcome of NSCLC patients. We first provided in vivo biodistribution of [¹⁸F]TTDP PET imaging in rhesus macaque, indicating its excellent translational potential in the clinic.

04 Sep 2024·Future Oncology

IMbrave152/SKYSCRAPER-14: a Phase III study of atezolizumab, bevacizumab and tiragolumab in advanced hepatocellular carcinoma

Article

Author: Li, Daneng ; Lin, Ya-Chen ; Cotter, Christopher ; Kudo, Masatoshi ; Zhu, Huaqi ; Badhrinarayanan, Shreya

Atezolizumab plus bevacizumab is a standard of care, first-line therapy for advanced hepatocellular carcinoma (HCC). Myeloid and T regulatory cells are key immunosuppressive cell types within the hepatic tumor microenvironment associated with clinical resistance to atezolizumab and bevacizumab therapy for HCC and overall poor prognosis. Therapeutic targeting of TIGIT, which is highly expressed in these cells, with tiragolumab may overcome the immunosuppressive environment and improve clinical benefit, a hypothesis supported by positive efficacy signals in the Phase Ib/II MORPHEUS-Liver study. This paper describes the rationale and design of IMbrave152/SKYSCRAPER-14, a randomized, double-blind, placebo-controlled Phase III study comparing atezolizumab and bevacizumab with tiragolumab or placebo in patients with HCC and no prior systemic treatment.Clinical Trial Registration: NCT05904886 (ClinicalTrials.gov).

01 Aug 2024·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

A non-comparative, randomized, phase II trial of atezolizumab or atezolizumab plus tiragolumab for programmed death-ligand 1-positive recurrent cervical cancer (SKYSCRAPER-04)

Article

Author: Kim, Yong-Man ; Lu, Chien-Hsing ; Colombo, Nicoletta ; McCormack, Mary ; Hu, Youyou ; Krishnan, Venkatesh ; Castro, Marcela ; Guzman Ramirez, Adrian ; Sabatier, Renaud ; Monk, Bradley J ; Feng, Yuning ; Ghamande, Sharad ; Hall, Shaundra L ; Barraclough, Lisa ; Salani, Ritu ; Lin, Yvonne G ; Gilbert, Lucy ; Kim, Nicole ; Lorusso, Domenica ; Molinero, Luciana

Objective:

To evaluate tiragolumab (anti-TIGIT) and atezolizumab (anti-PD-L1) as second- or third-line therapy for PD-L1-positive persistent/recurrent cervical cancer.

Methods:

In the open-label, non-comparative, randomized phase II SKYSCRAPER-04 trial ( NCT04300647 ), patients with PD-L1-positive (SP263 tumor area positivity ≥5%) recurrent/persistent cervical cancer after 1–2 chemotherapy lines (≥1 platinum-based) were randomized 3:1 to atezolizumab 1200 mg with/without tiragolumab 600 mg every 3 weeks until disease progression or unacceptable toxicity. Stratification factors were performance status, prior (chemo)radiotherapy, and disease status. The primary endpoint was independent review committee-assessed confirmed objective response rate per RECIST v1.1 in patients receiving tiragolumab plus atezolizumab. An objective response rate ≥21% (one-sample z-test p≤0.0245) was required for statistical significance versus a historical reference.

Results:

Protocol-defined independent review committee-assessed objective response rates were 19.0% (95% CI 12.6 to 27.0) in 126 patients receiving tiragolumab plus atezolizumab (p=0.0787 vs historical reference) and 15.6% (95% CI 6.5 to 29.5) in 45 atezolizumab-treated patients. Response rates were higher in PD-L1 high (tumor area positivity ≥10%) than PD-L1 low (tumor area positivity 5%–9%) subgroups with both regimens. At 8.5 months’ median follow-up, independent review committee-assessed progression-free survival was 2.8 months (95% CI 1.7 to 4.1) with tiragolumab plus atezolizumab and 1.9 months (95% CI 1.5 to 3.0) with atezolizumab. In post hoc analyses (10.4 months’ median follow-up), median overall survival was 11.1 months (95% CI 9.6 to 14.5) with the combination and 10.6 months (95% CI 6.9 to 13.8) with atezolizumab (crossover permitted). In the combination group, 3% of patients had adverse events requiring treatment discontinuation and 8% had grade ≥3 adverse events of special interest; corresponding values in the single-agent arm were 4% and 11%. There were no treatment-related deaths or new safety findings.

Conclusion:

The objective response rate with the tiragolumab-plus-atezolizumab combination was numerically higher than the historical reference but did not reach statistical significance.

News (Medical) associated with Tiragolumab

26 Nov 2024

·endpts.com

Updated: Roche buys out CAR-T partner Poseida for $1B upfront

Roche is acquiring its cell therapy and genomic medicines partner Poseida Therapeutics, the companies said Tuesday morning. The Basel-based pharma giant will pay $9 per share in upfront cash, giving Poseida an equity value of about $1 billion. If certain therapies enter pivotal studies and get commercialized, Poseida’s shareholders could get up to an additional $4 per share. Poseida’s shares $PSTX skyrocketed 224% after the opening bell, rising slightly above the $9 buyout price. Roche also said Tuesday morning that its drug tiragolumab failed a late-stage cancer study, dealing another blow to the TIGIT field. The Swiss drugmaker appears to have wanted to scoop up Poseida well in advance of having to dish out more money. The duo linked arms in August 2022 in a partnership that could have been worth up to $6 billion . That’s if all milestones were met, a rare feat in drug R&D. Roche had already delivered $80 million in milestones so far this year, but it dropped an option for one of Poseida’s CAR-Ts in September. “We do really think this is only the beginning. And when you think about it this way, then the answer becomes almost a foregone conclusion that there is so much complementarity, there is so much potential, we should become one,” Aviv Regev, head of research and early development at Genentech, said in an interview with Endpoints News . Regev said Poseida will continue its partnership with Astellas, which had done a $50 million equity investment in the company and paid $50 million upfront, with more than $500 million in additional payments on the line. Another Tokyo-based drugmaker, Takeda, had dropped its alliance with Poseida in the summer of 2023. Poseida has about 350 employees , Roche said. The teams have been working together for about two years, so “the relationships are all in place,” Regev said. “We plan to keep the site in San Diego for the foreseeable future,” she added. “There will be a large team there” that does both research and clinical manufacturing. Roche is getting access to a pipeline of off-the-shelf CAR-T therapies, meaning they derive from donors rather than the patient themselves, unlike most of the approved cell therapies. The biotech is working on blood cancers, solid tumors, autoimmune diseases and neurology. Poseida has presented some clinical data in multiple myeloma. It will also move into multiple sclerosis and systemic lupus erythematosus, Regev said, with IND filings recently submitted. Poseida focuses on stem cell memory T cells, which are the “ideal type for allogeneic cell therapies,” former CEO Mark Gergen previously said. “Roche’s global capabilities in late-stage development and commercialization will enable patients worldwide to benefit from the transformative potential of allo CAR-T,” Poseida CEO Kristin Yarema said in a press release. Beyond its multiple cell therapies already being tested in humans, the San Diego biotech is also working on preclinical non-viral genomic medicines for hereditary angioedema and hemophilia A. Roche adjusted its work in the cell therapy field earlier this year. Its Genentech unit had broken off a different off-the-shelf pact, saying goodbye to Adaptimmune and their work on αβ T cell therapies and αβ T cell receptors. Meanwhile, Roche ended development of an autologous TCR-based T cell therapy with partner Adaptive Biotechnologies in April, a Roche spokesperson said in an email, but it “will continue to work with Adaptive on T cell therapies.” Roche’s broad cell therapy work also touches ophthalmology, where it’s in Phase 2 with partner Lineage Cell Therapeutics . The Poseida deal marks a trio of acquisitions for Roche this fall. It bought Regor’s CDK inhibitors for $850 million upfront and paid an undisclosed amount for Wnt agonism-focused AntlerA and the startup’s suite of preclinical candidates in ophthalmology. It also completed its multibillion-dollar acquisition of obesity biotech Carmot Therapeutics at the beginning of the year. Will Roche buy more of its partners? “Every particular partnership is its own special snowflake, so then you can’t generalize,” Regev said. Roche and Poseida anticipate their deal will close in the first quarter. Editor’s note: This story was updated to include details from an interview with Genentech executive Aviv Regev.

Cell TherapyAcquisitionImmunotherapyPhase 2

26 Nov 2024

·endpts.com

Roche’s TIGIT drug misses last shot at survival endpoint win in Phase 3 lung cancer trial

Roche’s TIGIT drug has failed to clear the final hurdle in a late-stage cancer trial in what’s proving to be a mostly disappointing year for a drug class that was once seen as the next big thing in immuno-oncology. The Swiss pharma’s tiragolumab plus Tecentriq missed the overall survival endpoint in the final analysis of the Phase 3 SKYSCRAPER-01 study in previously untreated PD-L1-high locally advanced unresectable or metastatic non-small cell lung cancer, according to a Tuesday release . The trial had missed its other primary endpoint of progression-free survival two years ago, but Roche was hoping to bounce back with OS data. Ten minutes after disclosing its TIGIT miss on Tuesday, Roche said it was buying its cell therapy partner Poseida Therapeutics for $1 billion upfront. It’s been a bad year for tiragolumab. In July, the TIGIT drug combined with Tecentriq and chemotherapy missed both the PFS and OS endpoints in a separate Phase 3 trial in patients with previously untreated, locally advanced unresectable or metastatic nonsquamous NSCLC. That failure prompted the drugmaker to shutter two other studies in different forms of NSCLC as part of a broader pipeline reshuffle. Tiragolumab did score one Phase 3 win in January, when it met both survival endpoints in the SKYSCRAPER-08 study in Asian patients with certain forms of esophageal squamous cell carcinoma. However, the trial’s comparator arm tested chemotherapy and placebo, which didn’t stack up with the latest standard of care that includes checkpoint inhibitors. Elsewhere, there was some hope for the TIGIT space in September, when GSK and iTeos reported that belrestotug combined with Jemperli improved overall response rates by more than 30 percentage points compared with Jemperli alone in a Phase 3 trial in people with previously untreated PD-L1-high locally-advanced or metastatic NSCLC. But in May, Merck was forced to wind down a late-stage test of its anti-TIGIT drug vibostolimab in skin cancer after a high number of patient dropouts due to immune side effects.

Phase 3Clinical ResultCell TherapyClinical Trial Failure

26 Nov 2024

·www.businesswire.com

Genentech Reports Update on Phase III SKYSCRAPER-01 Study Results

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reports an update on the Phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq ® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 is a global Phase III, randomized, double-blinded study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic NSCLC. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit, or unacceptable toxicity. The study did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025. Genentech continuously reviews its study programs to determine if any adjustments are necessary for the purposes of ongoing research. Genentech will apply the same principles to this program, with additional data from Phase III studies across different settings or tumor types anticipated next year. About tiragolumab Tiragolumab is an investigational immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer. About Tecentriq ® (atezolizumab) Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. Tecentriq U.S. Indications Tecentriq is a prescription medicine used to treat adults with: Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Tecentriq may be used alone as a treatment for their lung cancer: to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and their cancer tests positive for “PD-L1.” Tecentriq may be used alone as their first treatment when their lung cancer: has spread or grown, and their cancer tests positive for “high PD-L1,” and their tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer: has spread or grown, and is a type called “non-squamous NSCLC,” and their tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer: has spread or grown, and is a type called “non-squamous NSCLC,” and their tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq may be used alone when their lung cancer: has spread or grown, and if they have tried chemotherapy that contains platinum, and it did not work or is no longer working. if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. It is not known if Tecentriq is safe and effective when used in children for the treatment of NSCLC. Important Safety Information What is the most important information about Tecentriq? Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended. Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of the skin or the whites of the eyes severe nausea or vomiting pain on the right side of their stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation their voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in their amount of urine blood in their urine swelling of their ankles loss of appetite Skin problems rash itching skin blistering or peeling painful sores or ulcers in mouth or nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes Problems can also happen in other organs. These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including: Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight Persistent or severe muscle pain or weakness, muscle cramps Low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feeling like passing out fever back or neck pain Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor for these complications. Getting medical treatment right away may help keep these problems from becoming more serious . A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq if patients have severe side effects. Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to their chest area have a condition that affects their nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant: A healthcare provider should do a pregnancy test before they start treatment with Tecentriq They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq. Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of Tecentriq when used alone include: feeling tired or weak decreased appetite nausea cough shortness of breath The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include: feeling tired or weak nausea hair loss constipation diarrhea decreased appetite Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility. These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq. Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch . Report side effects to Genentech at 1-888-835-2555. Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com .

Phase 3ImmunotherapyClinical ResultRadiation Therapy

100 Deals associated with Tiragolumab

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D11482	-	-	DB16409

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Indication	Highest Phase	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	CN	F. Hoffmann-La Roche Ltd.	01 Mar 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	CN	Genentech, Inc.	01 Mar 2024
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	CN	Roche China Holding Ltd.	01 Mar 2024
Hepatocellular Carcinoma	Phase 3	US	Roche Holding AG	14 Sep 2023
Hepatocellular Carcinoma	Phase 3	CN	Roche Holding AG	14 Sep 2023
Hepatocellular Carcinoma	Phase 3	JP	Roche Holding AG	14 Sep 2023
Hepatocellular Carcinoma	Phase 3	BE	Roche Holding AG	14 Sep 2023
Hepatocellular Carcinoma	Phase 3	BR	Roche Holding AG	14 Sep 2023
Hepatocellular Carcinoma	Phase 3	CA	Roche Holding AG	14 Sep 2023
Hepatocellular Carcinoma	Phase 3	CI	Roche Holding AG	14 Sep 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04294810 (SKYSCRAPER-01, GlobeNewswire) Manual	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer PD-L1 High Expression	534	tiragolumab + Tecentriq	opsyguztfv(mnsupngfdx) = did not reach the primary endpoint. uhbxrebjmt (ydhfvjldyj ) Not Met View more	Negative	26 Nov 2024
				Placebo + Tecentriq
NCT05315713 (CTgov)	Phase 1/2	Follicular Lymphoma \| B-cell lymphoma refractory	8	Mosunetuzumab SC+tocilizumab+Tiragolumab	elqrefwjoq(gtpxbdhbvn) = ephuyfomfq hkjhhcbsap (opgiabiasz, zikodmxihn - xpzqceolyd) View more	-	04 Oct 2024
NCT04619797 (SKYSCRAPER-06, Company_Website) Manual	Phase 2/3	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line	542	tiragolumab+Tecentriq+chemotherapy	borvnxcqcm(urnmxrujrh): HR = 1.27 (95% CI, 1.02 - 1.57) Not Met View more	Negative	03 Jul 2024
				Placebo+pembrolizumab+chemotherapy
NCT04300647 (SKYSCRAPER-04, AACR2024)	Phase 2	PD-L1+ \| TIGIT \| TAP ... View more	171	Tiragolumab plus atezolizumab dual blockade (T+A)	bnjmlseygy(abefinnfaq) = jeqnfvrybt iyssshxgrs (vrrzqtpgct )	Positive	22 Mar 2024
NCT04256421 (SKYSCRAPER-02, Pubmed) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line \| Maintenance	490	Tiragolumabatezolizumabcarboplatinetoposide	akzribraxr(kdntvjwdya) = odebiqnzwg qtlfjgtues (zqhnztqptm ) View more	Negative	20 Jan 2024
				AtezolizAtezolizumabrbocarboplatinetoetoposideE)	akzribraxr(kdntvjwdya) = slaqperavs qtlfjgtues (zqhnztqptm ) View more
NCT04540211 (SKYSCRAPER-08, ASCO_GI2024) Manual	Phase 3	Esophageal Squamous Cell Carcinoma First line PD-L1	461	Tiragolumab 600mg + Atezolizumab 1200mg + Chemotherapy	dviuwguytn(llzwyyfwnt) = xvxfjzpwfn ieaxixaqoj (yjdkguihlb ) View more	Positive	18 Jan 2024
				Placebo + Chemotherapy	dviuwguytn(llzwyyfwnt) = tzwvtunhra ieaxixaqoj (yjdkguihlb ) View more
NCT03281369 (MORPHEUS-EC, ASCO_GI2024) Manual	Phase 1/2	Esophageal Carcinoma First line	152	Cisplatin + 5-FU	klthyaroog(rhiwkrnuvj) = pfqjjmmfod oapedcrdbv (wwrggigpjh, 26.8 - 69.4) View more	Positive	18 Jan 2024
				Atezolizumab + Cisplatin + 5-FU	klthyaroog(rhiwkrnuvj) = tpjhwwvvwh oapedcrdbv (wwrggigpjh, 41.0 - 66.3) View more
NCT02794571 (GO30103, Pubmed \| JAMA Oncol)	Phase 1	Advanced Malignant Solid Neoplasm programmed death ligand 1-selected tumors	-	Tiragolumab	tkioxvahdv(niederkdll) = The most frequent treatment-related adverse events (AEs) were fatigue (5 of 24 [21%]) in phase 1a and pruritus (5 of 49 [10%]) in phase 1b; the majority of AEs were grade 1 or 2. bwpintclpj (faucqfhtnc ) View more	Positive	01 Nov 2023
				Atezolizumab
NCT04294810 (SKYSCRAPER-01, BusinessWire) Manual	Phase 3	metastatic non-small cell lung cancer First line PD-L1 High Expression	534	Tiragolumab+Atezolizumab	omdsxaxmbm(btzghczbok) = tlgcpkivmr zagvimkkju (gbwrccyejl, 17.5 - NE)	Positive	23 Aug 2023
				Placebo+Atezolizumab	omdsxaxmbm(btzghczbok) = rhqgtuzmfp zagvimkkju (gbwrccyejl, 14.6 - 20.2)
NCT04524871 (Morpheus-Liver, ASCO2023) Manual	Phase 1/2	Metastatic hepatocellular carcinoma First line	58	Atezolizumab+Bevacizumab+Tiragolumab	sstqjftffo(sfbblvdbfa) = vwmhfljhib aytaerlqzs (bnjrmywnzs ) View more	Positive	31 May 2023
				Atezolizumab+Bevacizumab	sstqjftffo(sfbblvdbfa) = tkfoqhubgs aytaerlqzs (bnjrmywnzs ) View more

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis