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]

NCT06855225

/ Not yet recruitingPhase 2IIT

A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab (STRIDE) Plus Gemcitabine and Cisplatin (GEMCIS) in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma (cHCC-CCA)

This is a single arm phase 2 study of Single Tremelimumab with Regular Interval Durvalumab (STRIDE) plus Gemcitabine and Cisplatin (GEMCIS) in locally advanced unresectable/metastatic combined hepatocellular-cholangiocarcinoma (cHCC-CCA). Cycles 1 through 8 will be in 3 week intervals and Cycles 9+ will be in 4 week intervals. Tremelimumab is administered at 300mg intravenously once at Cycle 1. Durvalumab is administered at 1500mg intravenously every 3 weeks for Cycles 1-8, then every 4 weeks for Cycles 9+. Gemcitabine is administered at 1000mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Cisplatin is administered at 25mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur at screening and then every 9 weeks until the end of Cycle 9. Disease assessments will then occur every 8 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months treatment from Cycle 1 Day 1 is allowed.

Start Date01 Mar 2026

Sponsor / Collaborator

Hoosier Cancer Research Network

[+2]

NCT07122089

/ Not yet recruitingPhase 2IIT

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]

100 Clinical Results associated with Tremelimumab

100 Translational Medicine associated with Tremelimumab

100 Patents (Medical) associated with Tremelimumab

603

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·HEPATOLOGY

Comparative effectiveness of immunotherapy versus lenvatinib in advanced hepatocellular carcinoma: A real-world analysis using target trial emulation

Article

Author: Yang, Ju Dong ; Yeo, Yee Hui ; Singal, Amit G. ; Kim, Hyun-Seok ; Abou-Alfa, Ghassan K. ; Wang, Yun ; Ma, Kevin Sheng-Kai ; Kuo, Alexander ; Parikh, Neehar D. ; Ahn, Joseph C. ; Rich, Nicole ; Trivedi, Hirsh ; Ng, Wee Han ; Ayoub, Walid S.

Background and Aims::

Immunotherapy has emerged as an effective treatment for advanced HCC. We aimed to investigate the real-world effectiveness of immunotherapy compared to lenvatinib in HCC.

Approach and Results::

From the TriNetX database, we used a target trial emulation framework and identified patients with HCC who received first-line treatment with immunotherapy (atezolizumab/bevacizumab or tremelimumab/durvalumab) or lenvatinib between or between August 2018 and December 2023. OS was compared using Kaplan-Meier analysis and Cox proportional hazards regression. After propensity score matching, 1203 patients were included in each group. Immunotherapy was associated with improved OS versus lenvatinib (median survival: 545 vs. 425 d; HR: 0.86, 95% CI: 0.76–0.97). Regarding treatment type, atezolizumab plus bevacizumab showed improved survival compared to lenvatinib (n=1070 in each group; HR: 0.87, 95% CI: 0.77–0.99), while the point estimate favored durvalumab plus tremelimumab versus lenvatinib (HR: 0.81, 95% CI: 0.59–1.12), though this difference was not statistically significant, likely due to small sample size. Regarding etiology, immunotherapy had improved OS compared to lenvatinib in viral hepatitis (n=510 in each group; HR: 0.74, 95% CI: 0.61–0.89) and alcohol-associated liver disease (n=190 in each group; HR: 0.65, 95% CI: 0.49–0.87), but not in metabolic dysfunction–associated steatotic liver diseases (n=156 in each group; HR: 0.96, 95% CI: 0.70–1.31).

Conclusions::

In this real-world analysis, immunotherapy was associated with improved OS compared to lenvatinib in advanced HCC, with consistent benefit across most subgroups. These findings support the use of immunotherapy as a first-line treatment for advanced HCC.

15 Jan 2026·INTERNAL MEDICINE

Successful Sequential Immunotherapy for Multiple Primary Malignancies (Unresectable Hepatocellular Carcinoma and Esophageal Squamous Cell Carcinoma)

Article

Author: Kikuchi, Kentaro ; Akutsu, Tomohiro ; Tsujikawa, Takayuki ; Namura, Yuta ; Aso, Tatsuya ; Hayakawa, Jun ; Kikuyama, Tomohiro ; Adachi, Takako ; Saito, Go ; Matsumoto, Kotaro ; Takahashi, Mikiko ; Katsukura, Nobuhiro ; Doi, Shinpei ; Tsunashima, Hiromichi ; Okamoto, Kanji ; Watanabe, Ayako

Hepatocellular carcinoma and esophageal squamous cell carcinoma are aggressive malignancies, and their coexistence presents a significant treatment challenge. We herein report a rare case of multifocal hepatocellular carcinoma and esophageal squamous cell carcinoma that was successfully treated with sequential immune checkpoint inhibitors. Atezolizumab plus bevacizumab led to tumor regression, but following a brain infarction, the therapy was switched to durvalumab plus tremelimumab, and durable remission was achieved despite programmed death-ligand 1 (PD-L1) negativity. This case underscores the potential application of immune checkpoint inhibitors (ICIs) in the treatment of multiple primary malignancies and highlights the need for further research on predictive biomarkers and optimal combination strategies. This case also raises important questions regarding the mechanisms of ICI efficacy in PD-L1-negative malignancies, and suggests that immune synergy between coexisting tumors may enhance antitumor responses.

302

News (Medical) associated with Tremelimumab

15 Jan 2026

·www.sciencedaily.com

Scientists question the safety of BPA-free packaging

“BPA-free” food packaging may be hiding new risks. A McGill University study found that several BPA substitutes used in grocery price labels can seep into food and interfere with vital processes in human ovarian cells. Some triggered unusual fat buildup and disrupted genes linked to cell repair and growth. The results raise concerns that BPA replacements may be just as troubling as the chemical they replaced.Chemicals used as replacements for bisphenol A (BPA) in food packaging may have concerning effects on human ovarian cells, according to researchers at McGill University. In a new study, scientists analyzed several substances commonly found in price stickers attached to packaged meat, fish, cheese, and fresh produce. Their experiments revealed early warning signs of possible toxicity linked to these chemicals. The results, published in the journal Toxicological Sciences, raise new questions about whether BPA-free packaging is truly safer and whether existing regulations provide enough protection for consumers. BPA replacements linked to cellular changes The investigation built on a 2023 finding by Stéphane Bayen, Associate Professor in McGill's Department of Food Science and Agricultural Chemistry. His earlier research showed that chemicals used in label printing, including bisphenol S (BPS), a common BPA substitute, can migrate through plastic wrap and end up in food. To better understand what happens after exposure, Bayen partnered with experts in reproductive toxicology. The research team exposed lab-grown human ovarian cells to four widely used BPA alternatives: TGSA, D-8, PF-201 and BPS. Several of these substances, especially TGSA and D-8, led to fat droplet buildup inside the cells and altered the activity of genes involved in cell growth and DNA repair. "These are major cellular functions," said Bernard Robaire, co-senior author of the study and James McGill Professor in McGill's Departments of Pharmacology & Therapeutics and Obstetrics & Gynecology. "Disrupting them doesn't prove harm in humans, but it gives us a strong signal that these chemicals should be further investigated." BPA-free labels and regulatory blind spots BPA is known to interfere with hormone activity and has been associated with fertility issues, developmental problems, and metabolic disorders. Due to these risks, it has been banned from baby bottles and restricted in certain products in Canada. However, many of the chemicals introduced to replace BPA are not subject to the same level of oversight and are not routinely tested for safety, the researchers noted. "'BPA-free' is an incredibly misleading label," said Robaire. "It usually means one bisphenol has been swapped for another, and there are more than 200 of them. Some may be just as harmful, or even worse. We need to test these compounds before they're widely adopted, not after." Health Canada has since added all four chemicals examined in the study to a list of substances that require further review. For consumers who want to reduce potential exposure, Robaire advises removing price labels and plastic wrap from fresh foods before storing them. He also suggests choosing items from the top of display stacks at grocery stores, since pressure from stacked products below may increase the transfer of chemicals into food. About the study "High-content imaging and transcriptomic analyses of the effects of bisphenol S and alternative color developers on KGN granulosa cells" by Lama Iskandarani, Stéphane Bayen, Barbara Hales and Bernard Robaire was published in Toxicological Sciences. The research was supported by the McGill Sustainability Systems Initiative.

22 Dec 2025

·www.astrazeneca.com

Update on LATIFY Phase III trial of ceralasertib plus Imfinzi in previously treated advanced non-small cell lung cancer

The LATIFY Phase III trial of ceralasertib in combination with Imfinzi (durvalumab) did not meet the primary endpoint of overall survival (OS) versus standard-of-care docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The trial evaluated patients without actionable genomic alterations (AGAs) whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy. Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Our goal in the LATIFY trial was to reinvigorate the immune response of patients with lung cancer whose tumours stopped responding to available therapies by combining ATR inhibition with immunotherapy. While we are disappointed by this result, we remain committed to pioneering new medicines to address the urgent need to improve outcomes for patients with lung cancer through our industry-leading portfolio.” The combination of ceralasertib and Imfinzi was generally well tolerated, and the safety profile was consistent with the known profiles of each individual medicine, with no new safety concerns identified. These data will be presented at a forthcoming medical meeting. Notes NSCLC Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into small cell lung cancer (SCLC) or NSCLC, the latter accounting for about 80-85% of cases.2-3 Patients are mostcommonly diagnosed with metastatic disease, when the tumour has spread outside the lung.4 Approximately 12% of people with metastatic NSCLC will still be alive five years after diagnosis.5 LATIFY LATIFY is a randomised, open-label, multi-centre, global Phase III trial of ceralasertib plus Imfinzi in patients with locally advanced or metastatic NSCLC without AGAs, and whose disease has progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Patients were randomised 1:1 to receive ceralasertib 240mg twice daily oral tablets for seven days in combination with a 1,500mg fixed dose of Imfinzi on day eight every four weeks or docetaxel every three weeks until disease progression, unacceptable toxicity, withdrawal of consent or a discontinuation criterion was met. The trial enrolled 594 patients across more than 20 countries. The primary endpoint is OS and secondary endpoints include progression-free survival, objective response rate, duration of response, time to response, disease control rate and patient reported outcomes. Ceralasertib Ceralasertib is an oral, potent and selective inhibitor of the ATR kinase, which is crucial for DNA damage responses and cell survival. Ceralasertib acts on the tumour microenvironment, moving it from a suppressed immune state into an activated state when combined with immunotherapy. 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 lung cancer, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III 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 (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage 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. In addition to its indications in lung cancers, Imfinzi is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the European Union (EU), and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US. Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved for muscle-invasive bladder cancer. 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 gastrointestinal cancers. 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/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 Matthew Bowden Company Secretary AstraZeneca PLC Corporate and financial

ImmunotherapyClinical ResultPhase 3Drug ApprovalBiosimilar

22 Dec 2025

·www.drugs.com

Update on LATIFY Phase III Trial of Ceralasertib plus Imfinzi in Previously Treated Advanced Non-Small Cell Lung Cancer

22 December 2025 -- The LATIFY Phase III trial of ceralasertib in combination with Imfinzi (durvalumab) did not meet the primary endpoint of overall survival (OS) versus standard-of-care docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The trial evaluated patients without actionable genomic alterations (AGAs) whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy. Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Our goal in the LATIFY trial was to reinvigorate the immune response of patients with lung cancer whose tumours stopped responding to available therapies by combining ATR inhibition with immunotherapy. While we are disappointed by this result, we remain committed to pioneering new medicines to address the urgent need to improve outcomes for patients with lung cancer through our industry-leading portfolio.” The combination of ceralasertib and Imfinzi was generally well tolerated, and the safety profile was consistent with the known profiles of each individual medicine, with no new safety concerns identified. These data will be presented at a forthcoming medical meeting. NSCLC Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. 1 Lung cancer is broadly split into small cell lung cancer (SCLC) or NSCLC, the latter accounting for about 80-85% of cases. 2-3 Patients are most commonly diagnosed with metastatic disease, when the tumour has spread outside the lung. 4 Approximately 12% of people with metastatic NSCLC will still be alive five years after diagnosis. 5 LATIFY LATIFY is a randomised, open-label, multi-centre, global Phase III trial of ceralasertib plus Imfinzi in patients with locally advanced or metastatic NSCLC without AGAs, and whose disease has progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Patients were randomised 1:1 to receive ceralasertib 240mg twice daily oral tablets for seven days in combination with a 1,500mg fixed dose of Imfinzi on day eight every four weeks or docetaxel every three weeks until disease progression, unacceptable toxicity, withdrawal of consent or a discontinuation criterion was met. The trial enrolled 594 patients across more than 20 countries. The primary endpoint is OS and secondary endpoints include progression-free survival, objective response rate, duration of response, time to response, disease control rate and patient reported outcomes. Ceralasertib Ceralasertib is an oral, potent and selective inhibitor of the ATR kinase, which is crucial for DNA damage responses and cell survival. Ceralasertib acts on the tumour microenvironment, moving it from a suppressed immune state into an activated state when combined with immunotherapy. 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 lung cancer, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III 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 (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage 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. In addition to its indications in lung cancers, Imfinzi is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the European Union (EU), and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US. Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved for muscle-invasive bladder cancer. 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 gastrointestinal cancers. 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/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. References World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed November 2025. American Cancer Society. What Is Lung Cancer? Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed November 2025. Cagle PT, et al. Lung Cancer Biomarkers: Present Status and Future Developments. Arch Pathol Lab Med. 2013;137(9):1191-1198. Chen Y, Deng J, Liu Y, Wang H, Zhao S, He Y, Zhou C. Analysis of metastases in non-small cell lung cancer patients with epidermal growth factor receptor mutation. Ann Transl Med . 2021 Feb;9(3):206. American Cancer Society. Lung Cancer Survival Rates. Available at: https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed November 2025. Source: AstraZeneca

ImmunotherapyClinical ResultPhase 3Drug ApprovalBiosimilar

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.

to view more data

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

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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	qxjosalehb(oqldihjxer) = tfijhcxecr vzhekawedr (xjbflqeprw ) View more	Positive	08 Jan 2026
				Durvalumab + Tremelimumab + PET-directed chemoradiation (resected Pts)	qxjosalehb(oqldihjxer) = cojgothwtt vzhekawedr (xjbflqeprw )
IMbrave150 (ASCO_GI2026)	Phase 2/3	Advanced Hepatocellular Carcinoma First line	1,064	Tremelimumab + Durvalumab	bfeilpjmgx(jkghptglcq) = sccbyxdvld lfcvidgvyt (evjgzrdgga ) View more	Positive	08 Jan 2026
				Atezolizumab + Bevacizumab	bfeilpjmgx(jkghptglcq) = qbqtwbhmoc lfcvidgvyt (evjgzrdgga ) View more
ASCO_GI2026	Not Applicable	Advanced Hepatocellular Carcinoma First line	3,306	Bevacizumab-atezolizumab	nvisejceer(qnczuamrsd): HR = 0.873 (95.0% CI, 0.75 - 0.935), P-Value = 0.0016	Positive	08 Jan 2026
				Lenvatinib
NCT03298451 (HIMALAYA, ESMO_ASIA2025)	Phase 3	Unresectable Hepatocellular Carcinoma	321	Tremelimumab + Durvalumab	uxzwgfdgbw(oynkovixjt) = zglmvzpahn toocmynzpo (nkvhfnxfub, 14.46 - 33.35) View more	Positive	05 Dec 2025
				Durvalumab	uxzwgfdgbw(oynkovixjt) = ipyakbsrwl toocmynzpo (nkvhfnxfub, 15.84 - 23.85) View more
NCT07081633 (TREMENDOUS-2, ESMO_ASIA2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line	114	Lenvatinib+durvalumab+tremelimumab	pkrhvkdpaa(mydoxzjzym) = ypbhcnenkz slyflkqbea (jiftgtsfhk ) View more	Positive	05 Dec 2025
NCT02879318 (CCTG PA.7, ESMO2025)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma MTA \| SAM	173	gemcitabine/nab-paclitaxel+durvalumab+tremelimumab	zbhhseziys(nnxpvuunfh) = fxpbtutzsl fjjbtbzoue (dbikifejay ) View more	Positive	17 Oct 2025
				gemcitabine/nab-paclitaxel	zbhhseziys(nnxpvuunfh) = uptbhygnvc fjjbtbzoue (dbikifejay ) View more
NCT02819596 (CALYPSO, ESMO2025)	Phase 2	Advanced Renal Cell Carcinoma MET driven	138	Durvalumab	alsonzfbjf(jcfkecsdpy) = gvdktaaaeg gjsajankaw (zwznfmnxqt ) View more	Negative	17 Oct 2025
				Durvalumab + Tremelimumab	alsonzfbjf(jcfkecsdpy) = tmetukktoi gjsajankaw (zwznfmnxqt ) View more
NCT03288532 (RAMPART, ESMO2025)	Phase 3	Renal Cell Carcinoma Adjuvant	23	durvalumab	aegpkmpfpo(ehqwbxnbzc) = zsettzszsh kmlbxlrjjk (mvwbvlwaxp ) View more	Positive	17 Oct 2025
NCT03298451 (HIMALAYA, Pubmed \| J Hepatol)	Phase 3	Unresectable Hepatocellular Carcinoma	-	STRIDE (Tremelimumab plus Durvalumab)	yjtswnakuh(ikerkfuuur) = jyzcwqxkmp yltagxrwvy (oksggchjxr )	Positive	01 Oct 2025
				Sorafenib	yjtswnakuh(ikerkfuuur) = ztmiwdtokp yltagxrwvy (oksggchjxr )
NCT03518606 (MOVIE, Pubmed \| Breast)	Phase 2	Advanced breast cancer ER Negative \| PR Negative \| HER2 Negative	30	Tremelimumab plus Durvalumab combined to metronomic oral Vinorelbine	wmwtiumyrw(xgxyynqcqb) = irtpgspper jsnutcxcou (jvpgxksomh, 5.5 - 29.8) View more	Negative	01 Oct 2025

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