A Multicenter Open-label, Prospective Study to Evaluate the Efficacy and Safety of SIRT Using Yttrium-90 Glass Microspheres Followed by Durvalumab and Tremelimumab for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis

Hepatocellular carcinoma (HCC) is the most common primary liver cancer, being the third leading cause of cancer-related death worldwide, with approximately 745 000 deaths reported annually.
For advanced patients, including patients with tumoral portal vein thrombosis (PVT), most treatment guidelines recommend systemic therapy, either combination immunotherapy (IO) or combination of immunotherapy and anti-angiogenic treatment for first line option.
Results for PVT patients are provided in one trial with a median overall survival of 14.2 months with IO underlying the necessity to improve treatment of PVT patients. Two recent other phase 3 trials also reported positive results for different IO regimen.
Selective internal radiation therapy (SIRT) using yttrium-90 (90Y)-loaded glass microspheres (TheraSphereTM) can be used for patients with early stage to locally advanced HCC including PVT patients without extrahepatic spread (EHS). TheraSphereTM is recognized and is reimbursed in France for PVT patients without EHS, since 2019.Several retrospective studies have shown promising results for PVT patients.
Nowadays use of SIRT in locally advanced HCC is regaining interest based on the results of the randomized DOSISPHERE-01 study including non-operable patients, about 70% with PVT. This randomized Phase II trial using 90Y-loaded microspheres sought was noted the effectiveness of 90Y-loaded microspheres using a personalized dosimetry approach versus a standard dosimetry approach.
The use of a systemic treatment as IO after a locoregional treatment with the strong local debulking effect of SIRT is logical and of interest. Indeed, the most frequent pattern of progression after SIRT is recurrence in an untreated area, including untreated liver or EHS. Patients are then usually referred to IO.
Such kind of therapeutic approach, using SIRT followed by IO has already been evaluated in a phase 2 study using nivolumab after 90Y loaded resin microspheres with promising efficacy without safety deterioration.
The aim of this study is to evaluate SIRT followed by IO used according to their current indications in advanced HCC patient with PVT patients and without EHS.

Start Date02 Jan 2026

Sponsor / Collaborator

Center Eugene Marquis

[+1]

NCT06824363

/ Not yet recruitingEarly Phase 1IIT

Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082

This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.

Start Date01 Nov 2025

Sponsor / Collaborator

University of California, Irvine

NCT07166406

/ Not yet recruitingPhase 3IIT

Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)

This phase III trial compares the effect immunotherapy (IO) with stereotactic body radiation therapy (SBRT) to IO alone in treating patients with liver cancer (hepatocellular cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). The usual approach is treatment with IO-based drug combinations, such as atezolizumab and bevacizumab, durvalumab and tremelimumab, or ipilimumab and nivolumab. Durvalumab and tremelimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). IO with monoclonal antibodies, such as atezolizumab, nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving IO with SBRT may be more effective than IO alone in helping patients with advanced hepatocellular cancer live longer.

Start Date02 Oct 2025

Sponsor / Collaborator

NRG Oncology

100 Clinical Results associated with Tremelimumab

100 Translational Medicine associated with Tremelimumab

100 Patents (Medical) associated with Tremelimumab

657

Literatures (Medical) associated with Tremelimumab

31 Dec 2025·mAbs

Engineered ipilimumab variants that bind human and mouse CTLA-4

Article

Author: Barman, Ishita ; Diong, SJ ; Lee, Peter S. ; Bee, Christine ; Rajpal, Arvind ; Kumar, Anusha ; West, Sean M. ; Chau, Bryant ; Strop, Pavel ; Robison, Brett ; Chang, Olin ; Korman, Alan J. ; Moon, Thomas M.

Testing of candidate monoclonal antibody therapeutics in preclinical models is an essential step in drug development. Identification of antibody therapeutic candidates that bind their human targets and cross-react to mouse orthologs is often challenging, especially for targets with low sequence homology. In such cases, surrogate antibodies that bind mouse orthologs must be used. The antibody 9D9, which binds mouse CTLA-4, is a commonly used surrogate for CTLA-4 checkpoint blockade studies in mouse cancer models. In this work, we reveal that 9D9 has significant biophysical dissimilarities to therapeutic CTLA-4 antibodies. The 9D9-mCTLA4 complex crystal structure was determined and shows that the surrogate antibody binds an epitope distinct from ipilimumab and tremelimumab. In addition, while ipilimumab has pH-independent binding to hCTLA-4, 9D9 loses binding to mCTLA-4 at physiologically relevant acidic pH ranges. We used phage and yeast display to engineer ipilimumab to bind mouse CTLA-4 with single-digit nM affinity from an initial state with no apparent binding. The engineered variants showed pH-independent and cross-reactive binding to both mouse and human CTLA-4. Crystal structures of a variant in complex with both mouse and human CTLA-4 confirmed that it targets an equivalent epitope as ipilimumab. These cross-reactive ipilimumab variants may facilitate improved translatability and future mechanism-of-action studies for anti-CTLA-4 targeting in murine models.

01 Dec 2025·Journal of Gastrointestinal Cancer

The Efficacy and Safety of Durvalumab and Tremelimumab with Concomitant Treatment for MSS/pMMR Metastatic Colorectal Cancer: A Single Arm Meta-Analysis

Article

Author: Zhang, Danning ; Chen, Tianyu

OBJECTIVES:

To address the issue that most microsatellite-stable (MSS) and proficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC) patients have minimal response to immunotherapy, this meta-analysis evaluated the efficacy and safety of durvalumab and tremelimumab with concomitant treatment in treating MSS/pMMR metastatic colorectal cancer.

METHODS:

All included trials were prospective studies with a median patient age of 63 years, of which 94.2% were MSS/pMMR mCRC patients, with a male to female ratio of 1.5:1. Based on durvalumab and tremelimumab treatment, one study performed surgical resection on resectable cases, while the other four studies performed radiotherapy or chemotherapy on unresectable cases. Analyses include objective response rate (ORR).etc. for drug activity, overall survival (OS) and progression-free survival (PFS) for therapeutic efficacy, and adverse events (AEs) for safety. The risk of bias was assessed by sensitivity analysis.

RESULTS:

5 studies involving 228 patients were included in this meta-analysis. The pooled estimates showed a median OS of 9.26 months, median PFS of 2.53 months, partial response (PR) of 13.6%, stable disease (SD) of 32.8%, ORR of 12.5% and disease control rate (DCR) of 65.4%. AEs were generally low, with pruritus (27.5%), diarrhea (28.8%), and fatigue (53.9%) being the most common, while other AEs occurred at less frequencies.

CONCLUSIONS:

Durvalumab and tremelimumab with concomitant treatment for MSS/pMMR mCRC patients is relatively effective and safe, which is helpful in addressing the problem of mCRC with MSS/pMMR that has minimal response to immunotherapy.

01 Dec 2025·Journal of Gastrointestinal Cancer

Neutrophil-to-Lymphocyte Ratio (NLR) as a Predictive Biomarker in Advanced Hepatocellular Carcinoma Treated with First-Line Immunotherapy

Article

Author: Felismino, Tiago ; Martins, Luanna ; Brito, Angelo ; Maccali, Claudia ; Carvalho, Daniela ; Barroso, Matheus ; Coimbra, Felipe

PURPOSE:

Hepatocellular carcinoma (HCC) is a globally prevalent malignancy with high mortality and limited predictive biomarkers. The neutrophil-to-lymphocyte ratio (NLR), a systemic inflammation marker, has been proposed as a prognostic tool. This study aimed to evaluate the association between baseline NLR and clinical outcomes in patients with advanced HCC treated with first-line immunotherapy.

METHODS:

We conducted a retrospective analysis of 58 consecutive patients with advanced HCC treated with atezolizumab plus bevacizumab or durvalumab plus tremelimumab at a Latin American cancer center between July 2020 and March 2025. Baseline NLR was calculated from pretreatment blood counts and dichotomized using a cut-off of 4. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method and compared using the log-rank test. Univariable and multivariable Cox regression models were applied to assess prognostic and predictive factors. The association between NLR and disease control rate (DCR) was evaluated using logistic regression.

RESULTS:

Among 58 patients, 15 (28.8%) had NLR ≥ 4. Median PFS was significantly shorter in patients with NLR ≥ 4 compared to those with NLR < 4 (2.3 vs. 8.2 months; p < 0.001). In multivariable analysis, NLR ≥ 4 remained independently associated with inferior PFS (HR 3.90; 95% CI, 1.83-8.33; p < 0.001). NLR was not associated with OS. Patients with NLR ≥ 4 had markedly lower odds of achieving disease control (OR 0.04; 95% CI, 0.002-0.28; p = 0.005).

CONCLUSION:

Baseline NLR ≥ 4 is associated with inferior PFS and reduced DCR in patients with advanced HCC receiving immunotherapy. NLR may serve as a cost-effective predictive biomarker to inform immunotherapy strategy.

287

News (Medical) associated with Tremelimumab

19 Sep 2025

·www.prnewswire.com

Liver Cancer Therapeutics Market Size Surpasses USD 13.16 Billion by 2032, Increasing at a CAGR of 16.5% from 2025 to 2033

AUSTIN, Texas and TOKYO, Sept. 19, 2025 /PRNewswire/ -- According to DataM Intelligence, the global liver cancer therapeutics market size was valued at US$3.36 billion in 2024 and is expected to reach US$13.16 billion by 2033, growing at a CAGR of 16.5% during the forecast period 2025-2033. The liver cancer therapeutics market is entering a transformative phase, driven by the shift from traditional systemic therapies to innovative immunotherapies and targeted agents that offer improved survival outcomes. The growing adoption of combination regimens, particularly checkpoint inhibitors paired with VEGF or TKI therapies, is expected to redefine the treatment landscape and expand the eligible patient pool. At the same time, the rising prevalence of hepatocellular carcinoma worldwide, coupled with strong R&D pipelines and increasing regulatory approvals, positions this market for sustained growth. A significant advancement in liver cancer therapeutics is the approval of combination immunotherapy regimens. Notably, AstraZeneca's Imfinzi (durvalumab) plus Imjudo (tremelimumab) gained global recognition after the HIMALAYA trial demonstrated a meaningful overall survival benefit in patients with unresectable hepatocellular carcinoma. This approval provided a new first-line treatment option beyond tyrosine kinase inhibitors and VEGF-targeted therapies, offering durable survival outcomes for a subset of patients and reshaping the standard of care in advanced HCC. Another key advancement is the expansion of targeted oral therapies, which have improved safety and efficacy profiles. Drugs such as lenvatinib and cabozantinib have demonstrated substantial clinical activity as first- or second-line options, while ongoing research is investigating their use in combination with checkpoint inhibitors. The growing pipeline of next-generation TKIs and precision therapies, tailored to genetic and molecular profiles, is driving innovation, improving patient survival, and reinforcing the importance of oral targeted agents in the long-term management of HCC. Get a Sample PDF Brochure of the Report (Use Corporate Email ID for a Quick Response): The chemotherapy segment, based on therapy type, is expected to account for 39.1% of the liver cancer therapeutics market share. Chemotherapy remains a vital part of the liver cancer therapeutics market, especially for patients with intermediate-stage hepatocellular carcinoma (HCC) or those ineligible for surgical resection or transplantation. Trans-arterial chemoembolization (TACE) is a standard of care used in clinical settings and often combined with targeted therapies. Despite the rise of immunotherapies and precision drugs, chemotherapy remains vital due to its established protocols, lower costs, and widespread availability. Clinical studies are exploring the synergy of chemotherapeutic agents with immunomodulators to prolong survival and delay disease progression. The North American liver cancer therapeutics market was valued at 42.1% market share in 2024. North America is expected to dominate the liver cancer therapeutics market due to its robust healthcare infrastructure, high awareness, and significant investments in oncology research and development (R&D). For instance, in January 2025, researchers at Mount Sinai made a significant breakthrough in treating hepatocellular carcinoma (HCC), a type of liver cancer. Additionally, the rise in liver cancer incidence, driven by NAFLD, obesity, and chronic hepatitis C, has increased early diagnosis rates and demand for advanced therapeutics. The FDA's favorable regulatory pathways, including priority reviews and orphan drug designations, have accelerated drug approval, ensuring rapid market access. The liver cancer therapeutics market in the U.S. dominated the North America market with the largest revenue share in 2024, driven by the increasing investment in pharmaceuticals. The regulatory framework in the U.S. ensures only safe and effective drugs reach the market, which increases trust of patients and healthcare providers in the medicines. Furthermore, the involvement of major players and the launch of novel treatments contribute to its dominance. Regulatory approvals for innovative drugs support market expansion, making the U.S. a leader in liver cancer treatments. This environment fosters continuous innovation and growth. Get Customization in the Report as Per Your Business Requirements: Europe is the second-dominating region in the liver cancer therapeutics market, valued at 34.5% market share in 2024. The liver cancer therapeutics market in Europe is driven by the growing prevalence of hepatitis B and C infections, rising alcohol consumption, and increasing cases of non-alcoholic fatty liver disease (NAFLD). Supportive regulatory approvals for novel immunotherapies, combined with a well-established healthcare infrastructure and government-backed cancer screening programs, are driving the adoption of advanced treatment regimens. In the U.K., a high burden of liver disease linked to obesity, diabetes, and alcohol misuse is accelerating demand for effective HCC treatments. National Health Service (NHS) initiatives to expand early cancer diagnosis, along with faster access schemes for innovative oncology drugs, further drive uptake of immunotherapies and targeted therapies. The Asia-Pacific region in the Liver Cancer Therapeutics Market was valued at 23.5% market share in 2024. This region is witnessing significant growth due to the very high incidence of hepatitis B and C, particularly in China and Southeast Asia, which are leading causes of HCC. Rising investments in healthcare infrastructure, increased clinical trial activity, and expanding patient access to immuno-oncology drugs are driving market growth. In Japan, liver cancer remains a leading cause of cancer mortality, primarily associated with hepatitis virus infections and an ageing population. Strong government support for oncology research, rapid adoption of cutting-edge immunotherapies, and the presence of domestic pharmaceutical players are key factors driving therapeutic innovation and market expansion. For instance, in June 2025, Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K. received supplemental approval for their anti-PD-1 antibody, Opdivo, and BMSKK's anti-CTLA-4 antibody, Yervoy, in combination therapy in Japan to expand their use for treating unresectable hepatocellular carcinoma (HCC), a type of cancer. Purchase This Exclusive Report at Just USD 4350 Only: Key Liver Cancer Therapeutics Companies: Top companies in the liver cancer therapeutics market include AstraZeneca, Bayer AG, Eli Lilly, Bristol-Myers Squibb Company, Eisai Co., Ltd., Genentech and among others. Recent Developments in the Market In September 2025, Akeso, Inc. has dosed the first patient in its Phase II registrational trial, evaluating cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib for treating advanced hepatocellular carcinoma in patients previously treated with atezolizumab and bevacizumab. In July 2025, Apollo Proton Cancer Centre (APCC) has launched an 'Advanced Liver Cancers Clinic', an integrated clinic for primary liver cancers and liver metastases. Related Reports: Pediatric Oncology Drugs Market Size, Share, Industry, Forecast and Outlook (2024-2031) Cancer Immunotherapy Market Size, Trends & Forecast 2033 Hepatocellular Carcinoma Treatment Market Size, Share, Growth Trends and Forecast Report 2025-2033 About DataM Intelligence 4Market Research: DataM Intelligence 4Market Research is a comprehensive market intelligence platform offering syndicated and customized reports along with expert consulting across multiple industries, including chemicals, healthcare, agriculture, food & beverages, and more. With extensive experience and a strategy-focused approach, DataM provides businesses and individuals with reliable market insights, statistical forecasts, and personalized research solutions to help them make informed decisions and successfully bring innovations to market. To find out more, visit or follow us on Twitter, LinkedIn and Facebook. Contact: Mr. Sai Kiran DataM Intelligence 4market Research LLP Ground floor DSL Abacus IT Park, Industrial Development Area Uppal, Hyderabad, Telangana 500039 USA: +1 877-441-4866 Email: [email protected] Content Source: Visit Our Website: Logo: SOURCE DataM Intelligence 4 Market Research LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugPhase 2Drug ApprovalImmunotherapy

07 Sep 2025

·www.astrazeneca.com

Tagrisso plus chemotherapy demonstrated a median overall survival of nearly four years, the longest benefit ever reported in a global Phase III trial in EGFR-mutated advanced lung cancer

Positive results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to Tagrisso monotherapy in the 1st-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). These results will be presented today during the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain (abstract #PL02.04). In the final OS analysis, Tagrisso plus chemotherapy demonstrated a median OS of nearly four years (47.5 months) compared to approximately three years (37.6 months) for Tagrisso monotherapy. At 57% data maturity, results showed Tagrisso plus chemotherapy reduced the risk of death by 23% compared to Tagrisso monotherapy (based on a hazard ratio [HR] of 0.77; 95% confidence interval [CI] 0.61-0.96; p=0.0202). An estimated 63.1% of patients treated with the combination were alive at three years and 49.1% of patients were alive at four years compared to 50.9% and 40.8%, respectively, in the monotherapy arm. Importantly, the observed OS benefit for Tagrisso plus chemotherapy versus Tagrisso monotherapy was consistent across all prespecified subgroups. Patients in the control arm received standard of care, including chemotherapy, upon progression, supporting the relevance of the OS results. David Planchard, MD, PhD, Thoracic Oncologist at Gustave Roussy Institute of Oncology, Villejuif, France, and principal investigator for the trial, said: “The fundamental goals of lung cancer treatment are to extend survival while preserving patients' quality of life. These compelling results, which demonstrated unprecedented median overall survival, show this combination can achieve both of these goals and support osimertinib, with or without the addition of chemotherapy, as the standard of care for patients with 1st-line advanced EGFR-mutated lung cancer. With two highly effective osimertinib-based options for these patients, physicians can better tailor treatment to individual needs and help ensure the best possible outcome for each patient.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The latest FLAURA2 trial results set a new survival standard for patients, with Tagrisso plus chemotherapy demonstrating a median overall survival of nearly four years in 1st-line advanced EGFR-mutated lung cancer—surpassing the three-year benchmark established in the FLAURA trial. Over the past decade, Tagrisso has consistently delivered strong survival benefits and tolerable safety across all stages of non-small cell lung cancer, cementing its role as the backbone therapy in EGFR-mutated lung cancer.” Summary of OS results: FLAURA2 Tagrisso plus chemotherapy (n=279) Tagrisso monotherapy (n=278) Median OS (in months)i,ii, iii Tagrisso plus chemotherapy (n=279) 47.5 (41.0-NCiv) Tagrisso monotherapy (n=278) 37.6 (33.2 ,43.2) Hazard ratio (95% CI) Tagrisso plus chemotherapy (n=279) 0.77 (0.61-0.96) Stratified log-rank p-valuev Tagrisso plus chemotherapy (n=279) 0.0202 Number of deaths, n (%) Tagrisso plus chemotherapy (n=279) 144 (51.6) Tagrisso monotherapy (n=278) 171 (61.5) Data maturity Tagrisso plus chemotherapy (n=279) 57% OS rate at 24 months (%) Tagrisso plus chemotherapy (n=279) 79.7 (74.5-84.0) Tagrisso monotherapy (n=278) 71.5 (65.8-76.5) OS rate at 36 months (%) Tagrisso plus chemotherapy (n=279) 63.1 (57.1-68.5) Tagrisso monotherapy (n=278) 50.9 (44.8-56.6) OS rate at 48 months (%) Tagrisso plus chemotherapy (n=279) 49.1 (43.0-55.0) Tagrisso monotherapy (n=278) 40.8 (34.9-46.6) i. OS data cut-off date was 12 June 2025 ii. Median follow-up duration for OS in censored patients at data cut-off: 51.2 (0.2-60.4) months for Tagrisso plus chemotherapy and 51.3 (0.1-60.1) months for Tagrisso monotherapy iii. Calculated by Kaplan–Meier method iv. Not calculable v. For statistical significance, a 2-sided p-value of less than 0.04953, as determined by the O’Brien and Fleming spending rule, was required With longer follow-up, the safety profile of Tagrisso plus chemotherapy continued to be manageable and consistent with the established profiles of the individual medicines. Grade 3 or higher adverse events (AEs) from all causes occurred in 70% of patients in the Tagrisso plus chemotherapy arm, driven by well-characterised chemotherapy-related AEs, versus 34% in the Tagrisso monotherapy arm, similar to the rates reported at the primary analysis presented at the IASLC 2023 WCLC (64% versus 27%, respectively). Discontinuation rates due to AEs and on-target toxicities were low in both trial arms (12% versus 7%). Notes NSCLC Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.1-2 Approximately 75% of people are diagnosed with advanced NSCLC.3 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.4-6 While EGFR-tyrosine kinase inhibitors (TKI) have significantly improved outcomes in the 1st-line setting, mechanisms of resistance and disease progression are extremely common, and a significant unmet need exists in later-line settings for effective and well-tolerated treatment options.7-10 FLAURA2 FLAURA2 is a randomised, open-label, multi-centre, global Phase III trial in previously untreated patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV)NSCLC whose tumors have EGFR exon 19 deletion or exon 21 L858R mutations. Patients were treated with Tagrisso 80mg QD oral tablets with the addition of chemotherapy (pemetrexed (500mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC5) every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks. The trial enrolled 557 patients in more than 150 centres across more than 20 countries, including in the US, Europe, South America and Asia. The primary endpoint is PFS with OS as the key secondary endpoint. Tagrisso Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Tagrisso (40mg and 80mg QD oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC. Tagrisso is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy (CRT). Tagrisso is also approved in combination with chemotherapy in more than 80 countries, including the US, EU, China and Japan, for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC. There is an extensive body of evidence supporting the use of Tagrisso in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease. In late-stage disease, Tagrisso demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. Tagrisso is also being investigated in this setting in combination with Orpathys (savolitinib)in the SAFFRON Phase III trial and in combination with Datroway (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials. Tagrisso also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating in innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Oncology Corporate and financial

Clinical ResultPhase 3Drug Approval

06 Aug 2025

·pmlive.com

AstraZeneca’s Imfinzi/Imjudo regimen recommended by NICE to treat liver cancer

AstraZeneca (AZ) has announced that Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat certain cases of liver cancer. The health technology assessment agency has recommended in final draft guidance that the ‘STRIDE’ regimen (single tremelimumab regular interval durvalumab) be used on the NHS in England and Wales as a first-line treatment for adults with advanced or unresectable hepatocellular carcinoma (HCC). This marks the first approval by NICE of a dual immunotherapy for liver cancer, AZ outlined. Approximately 6,600 people are diagnosed with liver cancer every year in the UK, with HCC accounting for more than 75% of all primary liver cancers cases. Around 70% of patients are diagnosed at an advanced stage, at which point treatment options are limited and prognosis is poor. NICE’s decision on STRIDE was supported by results from the late-stage HIMALAYA study, in which AZ’s regimen was associated with a statistically significant improvement in overall survival compared to the previous standard-of-care treatment, sorafenib, a tyrosine-kinase inhibitor. Median overall survival for STRIDE was 16.4 months versus 13.8 months for sorafenib, while 49% and 31% of STRIDE-treated patients were alive at 18 and 36 months, respectively, compared to 42% and 20% for sorafenib. Tom Keith Roach, president of AstraZeneca UK, said: “This is a positive step forward for people with advanced liver cancer and the first time this kind of immunotherapy combination will be available for these patients, showing a significant improvement in the number of patients living for five years or longer.” Also welcoming the recommendation, Vanessa Hebditch, director of policy and communications at the British Liver Trust, said: “Liver cancer incidence is rising rapidly, and patients often face limited treatment choices… This decision by NICE brings an important new treatment option to patients with advanced liver cancer.” The announcement comes just three months after AZ’s AKT inhibitor Truqap (capivasertib) was recommended by NICE as part of a combination treatment for advanced breast cancer. The company also received two separate recommendations from the agency in January for the use Imfinzi and Tagrisso (osimertinib) in lung cancer.

ImmunotherapyClinical ResultDrug Approval

100 Deals associated with Tremelimumab

External Link

KEGG	Wiki	ATC	Drug Bank
D06657	Tremelimumab	-	DB11771

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatocellular Carcinoma	Canada	AstraZeneca Canada, Inc.	31 Aug 2023
Advanced Hepatocellular Carcinoma	European Union	AstraZeneca AB	20 Feb 2023
Advanced Hepatocellular Carcinoma	Iceland	AstraZeneca AB	20 Feb 2023
Advanced Hepatocellular Carcinoma	Liechtenstein	AstraZeneca AB	20 Feb 2023
Advanced Hepatocellular Carcinoma	Norway	AstraZeneca AB	20 Feb 2023
metastatic non-small cell lung cancer	European Union	AstraZeneca AB	20 Feb 2023
metastatic non-small cell lung cancer	Iceland	AstraZeneca AB	20 Feb 2023
metastatic non-small cell lung cancer	Liechtenstein	AstraZeneca AB	20 Feb 2023
metastatic non-small cell lung cancer	Norway	AstraZeneca AB	20 Feb 2023
Advanced Lung Non-Small Cell Carcinoma	Japan	AstraZeneca KK	23 Dec 2022
Non-Small Cell Lung Cancer	United States	AstraZeneca AB	10 Nov 2022
Unresectable Hepatocellular Carcinoma	United States	AstraZeneca AB	21 Oct 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	Phase 3	United States	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Japan	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Argentina	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Austria	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Brazil	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Canada	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Chile	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	France	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Germany	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Greece	AstraZeneca PLC	05 Aug 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03298451 (HIMALAYA, Pubmed \| J Hepatol)	Phase 3	Unresectable Hepatocellular Carcinoma	-	STRIDE (Tremelimumab plus Durvalumab)	aodaixjunl(bsuwdygmzl) = gsxcgzqfmb jvsuxsmagh (evayaroppc )	Positive	01 Oct 2025
				Sorafenib	aodaixjunl(bsuwdygmzl) = ushfdzhubd jvsuxsmagh (evayaroppc )
NCT03518606 (MOVIE, Pubmed \| Breast)	Phase 2	Advanced breast cancer ER Negative \| PR Negative \| HER2 Negative	30	Tremelimumab plus Durvalumab combined to metronomic oral Vinorelbine	wvtwovvval(vxcyxxsahb) = irutammieq xghfzkxgpb (fxpikbuyhc, 5.5 - 29.8) View more	Negative	01 Oct 2025
NCT03638141 (CTgov)	Phase 2	Hepatocellular Carcinoma	21	Tremelimumab+Durvalumab	uunexwwhqe = ujmqihtqkf chgsgnxmka (jqfmjcjuao, gowbofiafx - quedssoeeo) View more	-	17 Aug 2025
NCT03703297 (ADRIATIC, CTgov)	Phase 3	Small cell lung cancer limited stage	730	Durvalumab (Durvalumab)	uuofxwpkao(qyufranzwc) = lmsqcolvqw admwmjesbf (tskemlijmm, zmdyjulpie - tgtjqobmvt) View more	-	01 Aug 2025
				placebo (Placebo)	uuofxwpkao(qyufranzwc) = adbdhcovwp admwmjesbf (tskemlijmm, ejdaaxmhqw - dqjibfixog) View more
HIMALAYA Trial (ESMO_GI2025)	Not Applicable	-	233	Durvalumab+Tremelimumab	wgsafsugoy(nxuomjjybf) = buojyployo fkqeouvuvw (chdtyhtlgm, 43.2 - 73.9) View more	Positive	03 Jul 2025
				Durvalumab	gybgkadora(rayemkgzvh) = cmyzhhbsdv vpunzmtbgl (dfjpwsdpse, 8.0 - NR) View more
NCT02815995 (CTgov)	Phase 2	Kaposi Sarcoma \| Advanced Sarcoma	57	Tremelimumab+Durvalumab (Adipocytic Tumors Group)	tmeoittgvp = udoufmwoug oyvpwdknvm (glkvljjpfw, frgqwritjg - mpaxvtixua) View more	-	12 Jun 2025
				Tremelimumab+Durvalumab (Vascular Tumors Group)	tmeoittgvp = kaqodxbugy oyvpwdknvm (glkvljjpfw, vzkdiuhlxv - mnyettaxad) View more
NCT02821754 (2019-002767-98, Pubmed \| Gut)	Phase 2	Hepatocellular Carcinoma interferon responses \| antigen presentation \| ICOS ... View more	28	Tremelimumab plus Durvalumab	bzurbbusno(rwyguwcsgm) = rkefdhmewe lvbskxsqyo (tnrytuiyml )	-	01 Jun 2025
NCT05844046 (AIO-MONTBLANC, ASCO2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line Child-Pugh A \| AFP ≥400 ng/mL	70	Durvalumab + Tremelimumab	xvqwqqwcri(vjuufpfviv) = kuxydpcikg myjfeawwjz (edwadhrtpx ) View more	Positive	30 May 2025
ACTRN12617001325392 (BCT1703 DIAmOND, ESMO_BC 12025 \| ESMO_BC 22025) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma	68	Total	rfuqlkyjlg(fektcxkeag) = shugjpxldf kownkxblwz (txmywrgdvx ) View more	Positive	16 May 2025
				tremelimumabtremelimumab 75mg with durvalumab 1500mg Q4Wdurvalumab 1500mg Q4W and Trastuzumab 2mg/kg Q1W for 12 weeks with ongoing Q3W durvalumab 1120mgTrastuzumab 2mg/kg Q1W for 12 weeks with ongoing Q3W durvalumab 1120mg and Trastuzumab 6mg/kg (C1, estrogen receptor (ER)-positive (≥1%))	rfuqlkyjlg(fektcxkeag) = uoffstrqhj kownkxblwz (txmywrgdvx ) View more
NCT03164616 (POSEIDON, ESMO_ELCC2025)	Phase 3	metastatic non-small cell lung cancer First line EGFR/ALK wild-type	175	Durvalumab + Tremelimumab + Chemotherapy	qqqhxjratw(ubutppxbub) = D+T+CT demonstrated statistically significant improvements in both progression-free survival (PFS; HR 0.72; 95% CI 0.60-0.86; p = 0.0003) and overall survival (OS; HR 0.77; 95% CI 0.65-0.92; p = 0.0030) vs CT alone, leading to approvals for this regimen. D+CT significantly improved PFS vs CT (0.74; 95% CI 0.62-0.89; p = 0.0009), with a positive trend for OS improvement (HR 0.86; 95% CI 0.72-1.02; p = 0.0758) cnfufxfzzs (fjvqmnagfe ) View more	Positive	26 Mar 2025
				Durvalumab + Chemotherapy

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