This phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD[L]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Response and survival rates in advanced stage NSCLC, unlike other cancers, rely on response to first-line therapy. Immunotherapy with PD(L)1-based therapy, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. While immunotherapy has improved survival rate, the prognosis remains poor with most patients receiving chemotherapy after immunotherapy. Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid (DNA) which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. The first part of this trial, studying samples of blood and tissue in the laboratory from patients receiving immunotherapy may help doctors learn more about the effects PD(L)1-based therapy on cells. It may also help doctors understand how well patients respond to treatment and may help develop new individualized treatment strategies. The second part of this trial also tests the effect of second-line immunotherapy, such as tremelimumab and durvalumab or adagrasib and bevacizumab, in treating patients with NSCLC with specific genetic mutations that is growing, spreading or getting worse (progressive). Tremelimumab is a monoclonal antibody 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). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adagrasib, a type of targeted therapy, may stop the growth of tumor cells by blocking a protein needed for tumor cell growth and may kill them. 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. Giving second-line immunotherapy, tremelimumab and durvalumab or adagrasib with bevacizumab, may be safe, tolerable, and/or effective in treating patients with stage IIIB/IV NSCLC with specific genetic mutations.

Start Date21 Sep 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+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 Apr 2026

Sponsor / Collaborator

University of California, Irvine

NCT07391670

/ Not yet recruitingPhase 1

A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours

The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).

Start Date31 Mar 2026

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Tremelimumab

100 Translational Medicine associated with Tremelimumab

100 Patents (Medical) associated with Tremelimumab

634

Literatures (Medical) associated with Tremelimumab

01 Feb 2026·ENVIRONMENTAL POLLUTION

Inhibition of human organic anion transporter 4 (OAT4) activity by bisphenol analogues

Article

Author: Fardel, Olivier ; Le Vée, Marc ; Malnoë, David ; Le Mentec, Hélène

Organic anion transporter (OAT) 4 is a kidney and placental membrane protein implicated in the transport of xenobiotics, including pollutants. The present study was designed to determine whether environmental bisphenol (BP) analogues, including emerging bisphenol A substitutes, can interact with OAT4. 6-carboxyfluorescein-related OAT4 activity displayed by OAT4-overexpressing HEK-293 cells was inhibited by 7/23 BP analogues used at 10 μM, especially by the thermal paper-contained color developer Pergafast® 201 (PF201) and the flame retardants tetrabromobisphenol A (TBBPA) and tetrachlorobisphenol A (TCBPA), acting in a concentration-dependent manner (with IC₅₀ values in the 0.95-1.48 μM range). Most of these BP analogues moreover decreased membrane transport of estrone-3-sulfate, a hormonal endogenous substrate for OAT4. Some of them, especially PF201, additionally blocked activity of the renal transporters OAT1 and OAT3. Interaction of BP analogues with OAT4 was further supported by docking simulation studies, indicating that PF201 binds to the Arg473-containing electropositive pocket of OAT4, presumed to play a key role in inhibition of OAT4-mediated transport. BP analogues however failed to trans-stimulate OAT4 activity and OAT4-overexpressing cells exhibited no or marginally increased sensitivity to PF201, TBBPA and TCBPA, thus suggesting that these BP analogues are not or poorly transported by OAT4. In vitro to in vivo extrapolation finally demonstrated that occupational exposure to PF201 is predicted to result in human OAT4 inhibition. Overall, OAT4 was demonstrated to be a target for BP analogues, including BPA substitutes, with possible deleterious consequences in terms of OAT4-mediated transport of endogenous compounds or drugs, notably for workers exposed to PF201.

01 Feb 2026·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Next-generation therapies for hepatocellular carcinoma: CAR-T cell and anticancer peptide synergy

Review

Author: Kannan, H Thamarai ; Pan, Ieshita

Hepatocellular carcinoma (HCC), the most common primary liver cancer, is characterized by late diagnosis, limited treatment efficacy, and a highly immunosuppressive tumour microenvironment. Chronic liver injury, fibrosis, and inflammation are central to HCC pathogenesis, leading to genetic and epigenetic changes, particularly under oxidative stress from reactive oxygen species (ROS). Aberrant activation of pathways such as Wnt/β-catenin, contributes to uncontrolled proliferation, resistance to apoptosis, and metastasis. This review emphasizes how immunotherapy particularly immune checkpoint inhibitors and chimeric antigen receptor T (CAR-T) cell therapy, has reshaped HCC treatment approaches. Advances in CAR-T designs targeting antigens like GPC3, AFP, and PD-L1, have been engineered to address antigen heterogeneity, T-cell exhaustion, and poor tumour infiltration. Mutant p53 and PD-L1 in the tumour microenvironment pose challenges to therapy by suppressing T-cell activity. Furthermore, anticancer peptides (ACPs), such as Tv1, SHLP6, R-Tf-D-LP4, and MOTS-c, exhibit selective cytotoxicity, mitochondrial targeting, and disruption of tumour-promoting pathways. Nanotherapeutics like PIR NPs, ThermoDox, and liposomal drug formulations improve drug stability, delivery, and specificity, providing controlled release and reduced toxicity. The integration of CAR-T therapy with ACPs, nanomedicine, and dual-checkpoint blockade such as tremelimumab-durvalumab, and nivolumab-ipilimumab demonstrate improved tumour regression and survival outcomes. Combination strategies that modulate ROS levels, inhibit angiogenesis, and utilize peptide-drug conjugates show promise in preclinical and early clinical studies. This review highlights the therapeutic synergy of next-generation peptide, cellular, and nanoplatform-based therapies in enhancing outcomes for advanced HCC.

01 Feb 2026·HEPATOLOGY RESEARCH

Efficacy and Safety of Hypofractionated Radiation Therapy Combined With Immunotherapy for Hepatocellular Carcinoma With Vp4 Portal Vein Tumor Thrombosis

Article

Author: Nakagawa, Hayato ; Tanaka, Hideaki ; Toyomasu, Yutaka ; Fujiwara, Naoto ; Tamai, Yasuyuki ; Tameda, Masahiko ; Ogura, Suguru ; Nomoto, Yoshihito ; Owa, Hirono ; Kawachi, Mizuki ; Shigefuku, Ryuta ; Tsukimoto, Mone

ABSTRACT:

Background:

Hepatocellular carcinoma (HCC) with Vp4 portal vein tumor thrombosis (PVTT) has an extremely poor prognosis, and evidence for effective systemic therapy is limited. Preclinical studies suggest that hypofractionated radiation therapy (HFRT) may enhance immune checkpoint inhibitor (ICI) efficacy through immunogenic cell death and modulation of the tumor microenvironment.

Methods:

We conducted a retrospective feasibility study of HFRT combined with ICIs for unresectable HCC. Patients receiving atezolizumab plus bevacizumab (Atz/Bev) or durvalumab plus tremelimumab (Dur/Tre) as first‐line therapy between October 2020 and March 2025 were analyzed. Since July 2022, those with Vp4 PVTT received HFRT (5 Gy × 5) targeting PVTT with ICIs. Outcomes were compared among Vp4 patients with HFRT, Vp4 patients without HFRT, and patients without Vp4 invasion (non‐Vp4).

Results:

Eight Vp4 patients received HFRT plus ICIs (Atz/Bev, n = 5; Dur/Tre, n = 3). The best responses of the main intrahepatic lesions by RECIST 1.1 were complete response (CR) in 1 (12.5%), partial response (PR) in 6 (75%), and stable disease in 1 (12.5%), yielding a high objective response rate (ORR) of 87.5%. By mRECIST, CR was achieved in 3 patients (37.5%). Overall survival in Vp4 patients with HFRT was comparable to non‐Vp4 patients and significantly better than Vp4 patients without HFRT. No gastrointestinal bleeding or perforation occurred, and ALBI scores were preserved at 12 weeks.

Conclusions:

HFRT combined with ICIs is feasible, well tolerated, and may improve outcomes in HCC with Vp4 PVTT. Prospective studies are warranted to confirm efficacy and determine optimal treatment protocols.

305

News (Medical) associated with Tremelimumab

13 Feb 2026

·www.fiercepharma.com

Fierce Pharma Asia—Lilly, Innovent go 'beyond traditional licensing'; China indicts AZ; Madrigal inks siRNA deal

Eli Lilly and Innovent's $8.8 billion new partnership, China's indictment of AstraZeneca and Madrigal Pharmaceuticals' latest metabolic dysfunction-associated steatohepatitis deal made our news this week. Eli Lilly and Innovent Biologics have deepened their ties with a new type of deal. China has indicted AstraZeneca and its former top exec in the country following investigations that emerged in 2024. Madrigal has signed a potential $4.4 billion siRNA deal with a Chinese biotech. And more.1. Lilly, Innovent pen $8.8B oncology, immunology collab that 'moves beyond traditional licensing'Eli Lilly has made a different kind of deal with its longtime Chinese partner Innovent Biologics. For $350 million upfront and up to $8.5 billion in milestone payments, Innovent will use its antibody platform to develop oncology and immunology programs for potential post-phase 2 adoption by Lilly outside greater China. The platform deal is different from traditional asset-specific licensing arrangements and forms a strategic partnership between the firms.2. China indicts AstraZeneca and former exec Leon Wang over data, trade chargesChina has officially indicted AstraZeneca and its former China head Leon Wang, plus another senior employee, over charges of unlawful collection of personal information and illegal trade, according to AZ. The two former execs also face additional charges of medical insurance fraud. Under the case, the company is accused of illegal importation of cancer drugs Imfinzi, Imjudo and Enhertu. 3. Madrigal pens $4.4B deal for Ribo's preclinical siRNA programs in latest Rezdiffra MASH playMadrigal Pharmaceutical, looking to further consolidate its lead in metabolic dysfunction-associated steatohepatitis (MASH), is paying $60 million upfront for six preclinical small interfering RNA programs from China’s Ribo Life Science and its subsidiary Ribocure Pharmaceuticals. The goal is to selectively reduce the production of disease-driving proteins in MASH through gene silencing.4. Takeda inks $1.7B AI drug discovery deal with Iambic TherapeuticsTakeda has entered a multiyear partnership to use Iambic Therapeutics' artificial intelligence drug discovery platform, including a predictor of protein-ligand complexes called NeuralPLexer. The initial focus is oncology, gastrointestinal and inflammatory therapeutic areas. Iambic could receive milestones potentially worth more than $1.7 billion.5. Takeda downsizes Boston footprint amid consolidation effortMeanwhile, Takeda has put up more than 630,000 square feet of Boston office space for sublease as the company is on track to open its R&D facility in Kendall Square later this year. The company’s presence in the area will drop from 1.56 million square feet across seven buildings to 1.43 million square feet across four buildings.Other News of Note: 6. Kailera, Hengrui tout up to 12% weight loss in midstage study for obesity pill7. Roche settles Perjeta biosimilar suit with Organon, Henlius (Bloomberg)8. Fujifilm Biotechnologies crosses finish line on £400M UK antibody production, process development expansion9. Otsuka awareness campaign urges HCPs to see 'All of ADHD'10. Taiwan’s PharmaEssentia to build $46M manufacturing plant in Puerto Rico

License out/in

11 Feb 2026

·firstwordpharma.com

Biopharma bites: AstraZeneca's former China head formally charged, plus funding for GluBio, Galecto

China charges ex-AstraZeneca executive Leon WangGluBio gets $30M from Sanofi to move molecular glue duo to the clinicGalecto raises $275M for oncology, fibrosis pipeline China charges ex-AstraZeneca executive Leon WangChinese authorities have formally charged former AstraZeneca China president Leon Wang with illegal trading, unlawful collection of personal information and medical insurance fraud, the Financial Times reported Wednesday.Wang, who led AstraZeneca's China business for roughly a decade and has been detained since late 2024, was charged alongside another former employee and will be tried in Shenzhen, although a trial date hasn't been set yet. Iskra Reic has since stepped into Wang's former role.According to the report, the company's China subsidiary has also been accused of unlawful collection of personal data and illegal trading, though AstraZeneca said authorities have not alleged the company benefited from "illegal gain" as a result of the data practices. The subsidiary was not charged with medical insurance fraud.The accusations of illegal trading stem from a probe into the alleged unauthorised import and sale of AstraZeneca's cancer drug Imjudo (tremelimumab), which is approved in various markets, but not in China. Meanwhile, AstraZeneca has said it paid $3.5 million in import taxes to Chinese customs late last year to settle an investigation tied to the importation of Imjudo, as well as cancer therapies Imfinzi (durvalumab) and Enhertu (trastuzumab deruxtecan), though the company could still face penalties of up to $17.5 million.-Anna BratulicGluBio gets $30M from Sanofi to move molecular glue duo to the clinic Sanofi is backing GluBio Therapeutics, a startup with offices in Shanghai and San Diego that's developing potentially disease-modifying molecular glue degraders.The French pharma made a $30-million strategic equity investment in GluBio, and will receive an exclusive right of first negotiation to the biotech's two lead programmes: GLB-005 and GLB-007. They're slated to start Phase I testing for sickle cell disease (SCD) this year. GLB-005 selectively degrades WIZ, while GLB-007 is directed against WIZ and ZBTB7A; both targets are foetal haemoglobin (HbF) repressors. By degrading these proteins, the oral candidates are designed to activate HbF expression.-Elizabeth EatonGalecto raises $275M for oncology, fibrosis pipelineCancer and fibrosis drug developer Galecto raised a $275-million follow-on late on Tuesday through the sale of 14.5 million shares at $19 apiece. Its stock took a 7% haircut on Wednesday.The company plans to use the cash to fund preclinical and clinical studies of its pipeline programmes, which include galectin-3 inhibitor GB1211 and GB3226 (formerly BRM-1420), a dual ENL-YEATS and FLT3 inhibitor it acquired from Bridge Medicines in 2024. The former is in mid-stage testing for liver cirrhosis, non–small-cell lung cancer and other solid tumours; the latter is in a Phase I/II acute myeloid leukaemia study.-Elizabeth Eaton

Phase 1Drug Approval

02 Feb 2026

·www.astrazeneca.com

Imfinzi perioperative regimen recommended for approval in the EU by CHMP for patients with early gastric and gastroesophageal cancers

Recommendation based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of progression, recurrence or death and a 22% reduction in the risk of death for the Imfinzi regimen vs. chemotherapy alone If approved, Imfinzi regimen would be the first immunotherapy-basedperioperative therapy for patients in this setting in the EU AstraZeneca’s Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been recommended for approval in the European Union (EU) for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on event-free survival (EFS) and overall survival (OS) data from the MATTERHORN Phase III trial. The EFS results were presented during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. In a planned interim analysis, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone (based on an EFS hazard ratio [HR] of 0.71; 95% confidence interval [CI] 0.58–0.86; p<0.001). Estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm. An estimated 78.2% of patients treated with the Imfinzi-based perioperative regimen were event-free at one year, compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively. In the final OS analysis, results showed the Imfinzi and FLOT perioperative regimen demonstrated a statistically significant and clinically meaningful survival improvement, reducing the risk of death by 22% compared to chemotherapy alone (based on a HR of 0.78; 95% CI 0.63-0.96; p=0.021). An estimated 69% of patients treated with the Imfinzi-based regimen were alive at three years compared with 62% in the comparator arm. At each subsequent prespecified OS landmark, the survival curves indicated increasing separation, signaling a greater magnitude of benefit over time for the Imfinzi-based regimen. An OS benefit was observed regardless of PD-L1 status. OS results from MATTERHORN were presented in a Proffered Paper session at the European Society for Medical Oncology (ESMO) Congress 2025. Josep Tabernero, MD, PhD, head of the Medical Oncology Department at Vall d'Hebron University Hospital and director of the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain, and principal investigator in the MATTERHORN trial, said: This recommendation signals a major step forward for patients in the EU with early gastric and gastroesophageal junction cancers, who have historically faced high rates of recurrence and poor long-term outcomes despite curative-intent surgery and chemotherapy. This durvalumab-based perioperative regimen is the first immunotherapy approach to significantly extend survival in this setting, and if approved, should set a new standard of care.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Imfinzi plus FLOT demonstrated a durable, increasing long-term survival benefit in the MATTERHORN trial, with more than two-thirds of patients alive at three years. The CHMP recommendation marks further progress toward our goal to offer novel approaches in early-stage cancers where there is the greatest chance for cure and brings us closer to providing the third perioperative Imfinzi-based regimen in the EU.” Gastric cancer is the fifth leading cause of cancer death globally, with nearly one million people diagnosed each year.1 In 2024, there were roughly 43,000 drug-treated patients in the US, EU and Japan in early-stage and locally advanced gastric or GEJ cancer.2 Approximately 62,000 patients in these regions are expected to be newly diagnosed in this setting by 2030.3 The safety profile for Imfinzi and FLOT chemotherapy was consistent with the known profiles of each medicine, and the percentage of patients that completed surgery was similar compared to chemotherapy alone. Grade 3 or higher adverse events due to any cause were similar between the two arms (71.6% for Imfinzi and FLOT arm; 71.2% for comparator arm). Imfinzi is approved in the US and other countries in this same indication based on the MATTERHORN results. Regulatory applications are currently under review in Japan and several other countries. Notes Gastric and gastroesophageal junction cancers Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality.1 Nearly one million new patients were diagnosed with gastric cancer in 2022, with approximately 660,000 deaths reported globally.1 In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.4 GEJ cancer is a type of gastric cancer that arises from and spans the area where the oesophagus connects to the stomach.5 Disease recurrence is common in patients with resectable gastric cancer despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy.6 Approximately one in four patients with gastric cancer who undergo surgery develop recurrent disease within one year, and the five-year survival rate remains poor, with less than half of patients alive at five years.6-7 MATTERHORN MATTERHORN is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial evaluating Imfinzi as perioperative treatment for patients with resectable Stage II-IVA gastric and GEJ cancers. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 948 patients were randomised to receive a 1500mg fixed dose of Imfinzi plus FLOT chemotherapy or placebo plus FLOT chemotherapy every four weeks for two cycles prior to surgery. This was followed by Imfinzi or placebo every four weeks for up to 12 cycles after surgery (including two cycles of Imfinzi or placebo plus FLOT chemotherapy and 10 additional cycles of Imfinzi or placebo monotherapy). In the MATTERHORN trial, the primary endpoint is EFS, defined as time from randomisation until the date of one of the following events (whichever occurred first): RECIST (version 1.1, per blinded independent central review assessment) progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period; RECIST progression/recurrence during the adjuvant period; non-RECIST progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period or discovered during surgery; progression/recurrence confirmed by biopsy post-surgery; or death due to any cause. Key secondary endpoints include pathologic complete response rate, defined as the proportion of patients who have no detectable cancer cells in resected tumour tissue following neoadjuvant therapy, and OS. The trial enrolled participants in 176 centres in 20 countries, including in the US, Canada, Europe, South America and Asia. Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. In GI cancer, Imfinzi is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo (tremelimumab) in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC. Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved in the US, EU, Japan and other countries for patients with muscle-invasive bladder cancer based on results from the NIAGARA Phase III trial. Additionally, in May 2025, Imfinzi added to Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial. Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan. Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers. AstraZeneca in GI cancers AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2022, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.8 Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic, and colorectal cancers. In addition to its indications in BTC and HCC, Imfinzi is being assessed in combinations, including with Imjudo, in liver, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), is approved in the US and several other countries for HER2-positive advanced gastric cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Lynparza, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada). The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, in combination with bevacizumab with or without Imjudo as a 1st-line treatment in patients with advanced HCC, and as a 1st-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. Rilvegostomig is also being evaluated in combination with Enhertu in previously untreated, HER2-expressing, locally advanced or metastatic BTC. AstraZeneca is advancing multiple modalities that provide complementary mechanisms for targeting Claudin 18.2, a promising therapeutic target in gastric cancer. These include sonesitatug vedotin, a potential first-in-class ADC licensed from KYM Biosciences Inc., currently in Phase III development; AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development; and AZD4360, an antibody drug conjugate, currently being evaluated in a Phase I/II trial in patients with advanced solid tumours. In early development, AstraZeneca is developing C-CAR031 / AZD7003, a Glypican 3 (GPC3) armoured CAR T, in HCC. C-CAR031 / AZD7003 is being co-developed with AbelZeta in China where it is under evaluation in an IIT. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. 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/NYSE: 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 1. World Health Organization. International Agency for Research on Cancer. Stomach Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/7-stomach-fact-sheet.pdf. Accessed February 2026. 2. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html. Accessed February 2026. 3. Kantar Health, validated with SEER stage at diagnosis and Cabasag et al. and Kuzuu et al. 2021. 4. Li Y, et al. Global burden of young-onset gastric cancer: a systematic trend analysis of the global burden of disease study 2019. Gastric Cancer. 2024;27(4):684-700. 5. National Cancer Institute. Gastroesophageal junction. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastroesophageal-junction. Accessed February 2026. 6. Li Y, et al. Postoperative recurrence of gastric cancer depends on whether the chemotherapy cycle was more than 9 cycles. Medicine. 2022;101(5):e28620. 7. Ilic M, Ilic I. Epidemiology of stomach cancer. World J Gastroenterol. 2022;28(12):1187-1203. 8. World Health Organization. International Agency for Research on Cancer. World Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf. Accessed February 2026. Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

ImmunotherapyClinical ResultPhase 3Drug ApprovalASCO

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
Renal Cell Carcinoma	Phase 3	Spain	AstraZeneca UK Ltd.	14 Sep 2021
Urothelial Carcinoma of the Urinary Bladder	Phase 3	Italy	AstraZeneca AB	08 Sep 2021
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

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02962063 (ASCO_GI2026)	Phase 2	Adenocarcinoma of Esophagus	20	Durvalumab + Tremelimumab + PET-directed chemoradiation	loqykgyelh(yrnzmmwcor) = qqtnfbuxxn jnlvcvqbjj (tnglnfbuzx ) View more	Positive	08 Jan 2026
				Durvalumab + Tremelimumab + PET-directed chemoradiation (resected Pts)	loqykgyelh(yrnzmmwcor) = thgfxpjehg jnlvcvqbjj (tnglnfbuzx )
ASCO_GI2026	Not Applicable	Advanced Hepatocellular Carcinoma First line	3,306	Bevacizumab-atezolizumab	cihtirxohy(zrgslfzesl): HR = 0.873 (95.0% CI, 0.75 - 0.935), P-Value = 0.0016	Positive	08 Jan 2026
				Lenvatinib
IMbrave150 (ASCO_GI2026)	Phase 2/3	Advanced Hepatocellular Carcinoma First line	1,064	Tremelimumab + Durvalumab	aqimqcuzaz(mpfrlxwhmn) = spsfcbrpiq jhnhhekdht (eevgqbkljz ) View more	Positive	08 Jan 2026
				Atezolizumab + Bevacizumab	aqimqcuzaz(mpfrlxwhmn) = kweriuavza jhnhhekdht (eevgqbkljz ) View more
NCT03298451 (HIMALAYA, ESMO_ASIA2025)	Phase 3	Unresectable Hepatocellular Carcinoma	321	Tremelimumab + Durvalumab	roeeeqcxgo(agxvtjzbqa) = foybnihdrh csjemubhnu (netvpjpczy, 14.46 - 33.35) View more	Positive	05 Dec 2025
				Durvalumab	roeeeqcxgo(agxvtjzbqa) = pupskjdfov csjemubhnu (netvpjpczy, 15.84 - 23.85) View more
NCT07081633 (TREMENDOUS-2, ESMO_ASIA2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line	114	Lenvatinib+durvalumab+tremelimumab	mdvylludmo(bkgpxuuxtm) = ggjppftbur pjyvqazdvp (xffbxeveyb ) View more	Positive	05 Dec 2025
NCT02819596 (CALYPSO, ESMO2025)	Phase 2	Advanced Renal Cell Carcinoma MET driven	138	Durvalumab	fcrutchjwg(pvamckcggf) = yugpmmwflv hhcptwiquc (jddtpmspcv ) View more	Negative	17 Oct 2025
				Durvalumab + Tremelimumab	fcrutchjwg(pvamckcggf) = sqntpfawww hhcptwiquc (jddtpmspcv ) View more
NCT03288532 (RAMPART, ESMO2025)	Phase 3	Renal Cell Carcinoma Adjuvant	23	durvalumab	eoufwqckzg(jxnvpnbtsx) = sbjgnpxmai jnbgtpjtfv (qjezxnkjgy ) View more	Positive	17 Oct 2025
NCT02879318 (CCTG PA.7, ESMO2025)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma MTA \| SAM	173	gemcitabine/nab-paclitaxel+durvalumab+tremelimumab	oinpdshpqt(yjuibfetdc) = eeyfshgwgw orgachqaka (qgpkjcbaxe ) View more	Positive	17 Oct 2025
				gemcitabine/nab-paclitaxel	oinpdshpqt(yjuibfetdc) = fkgblhiyqo orgachqaka (qgpkjcbaxe ) View more
NCT03298451 (HIMALAYA, Pubmed \| J Hepatol)	Phase 3	Unresectable Hepatocellular Carcinoma	-	STRIDE (Tremelimumab plus Durvalumab)	kucatbvzgd(eurvzwocfu) = ocehhsvedf jaedxqretn (hrxgcmszmo )	Positive	01 Oct 2025
				Sorafenib	kucatbvzgd(eurvzwocfu) = uxpzqoythl jaedxqretn (hrxgcmszmo )
NCT03518606 (MOVIE, Pubmed \| Breast)	Phase 2	Advanced breast cancer ER Negative \| PR Negative \| HER2 Negative	30	Tremelimumab plus Durvalumab combined to metronomic oral Vinorelbine	mqptcghwrm(ielfypuwhn) = rsuaedwxik dwlyjnvoop (lbqfouemww, 5.5 - 29.8) View more	Negative	01 Oct 2025

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