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Last update 21 Mar 2026

Durvalumab

Last update 21 Mar 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Durvalumab (Genetical Recombination), Durvalumab (genetical recombination) (JAN), Durvalumab (USAN/INN)

+ [10]

Target

PDL1

Action

inhibitors

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [11]

Active Indication

Gastroesophageal junction adenocarcinomaStomach CancerEarly gastric cancer+ [208]

Inactive Indication

Adenocarcinoma of LungAdenocarcinoma of prostateAdvanced breast cancer+ [89]

Originator Organization

AstraZeneca UK Ltd.

Active Organization

Jiangsu Hailai Xinchuang Medical Technology Co., Ltd.

AstraZeneca PLC

NeoTX Therapeutics Ltd.

+ [19]

Inactive Organization

AstraZeneca GmbH

Fred Hutchinson Cancer Research Center

AVEO Pharmaceuticals, Inc.

+ [8]

License Organization

MedImmune Pharma BV

Ultimovacs ASAVall d'Hebron Institut d'Oncologia

+ [14]

Drug Highest PhaseApproved

First Approval Date

United States (01 May 2017),

Transitional Cell Carcinoma

RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia)

Structure/Sequence

Sequence Code 10069506H

Source: *****

Sequence Code 13384675L

Source: *****

893

Clinical Trials associated with Durvalumab

NCT07288034

/ Not yet recruitingPhase 2IIT

Immunotherapy Biomarker Collection for Metastatic NSCLC to Inform Adaptive Personalized Models Targeting Resistance (IMMUNO-BIOMAP)

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]

NCT05403723

/ SuspendedPhase 1IIT

A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

Start Date30 Jun 2026

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

NCT07332351

/ Not yet recruitingPhase 2IIT

Intravesical Nadofaragene Firadenovec With Neoadjuvant Chemotherapy and Durvalumab in Patients With Muscle Invasive Bladder Cancer (TRIFECTA)

This phase II trial tests the effect of intravesical nadofaragene firadenovec in combination with gemcitabine, cisplatin and durvalumab before (neoadjuvant) radical cystectomy (RC) in treating patients with muscle invasive bladder cancer. The combination of gemcitabine, cisplatin and durvalumab are already considered standard of care in the treatment of muscle invasive bladder cancer. This trial attempts to determine whether the addition of nadofaragene firadenovec to the current standard regiment is safe and can improve oncological outcomes for those with muscle invasive bladder cancer.
Nadofaragene firadenovec, a type of intravesical gene therapy, is a weakened adenovirus that carries a copy of the gene for interferon alfa-2b. This medication gets absorbed by the bladder and stimulates the bladder to naturally create interferon alfa-2b, which is thought to kill bladder cancer. Nadofaragene firadenovec is given in a solution that is placed directly into the bladder (intravesical) using a thin tube called a catheter. It is a medication that is already FDA approved for the treatment of non-muscle invasive bladder cancer. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. 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.

Start Date01 Jun 2026

Sponsor / Collaborator

University of Washington

[+1]

100 Clinical Results associated with Durvalumab

100 Translational Medicine associated with Durvalumab

100 Patents (Medical) associated with Durvalumab

2,269

Literatures (Medical) associated with Durvalumab

01 May 2026·CANCER LETTERS

ERRα-ETV5 axis drives PD-L1 upregulation and immune escape in gallbladder cancer

Article

Author: Guo, Xingmei ; Chen, Yu ; Lu, Xinyi ; Chen, Daozhen ; Wen, SiJia ; Wang, Lei ; Wu, Fan ; Zhao, Hui ; Sun, Ping ; Yang, Mengmeng ; Gong, Wanwan

Gallbladder cancer (GBC) is a highly aggressive malignancy with a poor response to immune checkpoint blockade (ICB), highlighting an urgent need to understand the mechanisms of immune evasion. We identified the orphan nuclear receptor ERRα as a critical regulator of the immunosuppressive tumor microenvironment in GBC. Mechanistically, we discovered that ERRα transcriptionally upregulates the ETS-family transcription factor ETV5, which in turn directly binds to and activates the PD-L1 (CD274) promoter, establishing a novel ERRα-ETV5-PD-L1 signaling axis. In clinical specimens, ERRα expression positively correlated with PD-L1 levels and served as an independent prognostic factor for poor survival. Using a combination of human GBC tissues, in vitro co-culture systems, and a humanized mouse model, we demonstrated that genetic or pharmacological inhibition of ERRα downregulated PD-L1 and potentiated CD8⁺ T cell-mediated cytotoxicity. Critically, combined targeting of ERRα (using the inverse agonist XCT790) and PD-L1 (using durvalumab) synergistically suppressed tumor growth and enhanced intratumoral T cell infiltration in vivo. Our findings reveal ERRα as a master transcriptional regulator of immune evasion and highlight the therapeutic potential of co-inhibiting the ERRα-ETV5-PD-L1 axis to overcome immunotherapy resistance in GBC.

01 Apr 2026·Gynecologic Oncology Reports

Cost effectiveness analysis of immunotherapy regimens currently approved in advanced or recurrent endometrial cancer: An analysis of the NRG-GY 018, RUBY, and DUO-E trials

Article

Author: Richardson, Michael T ; Chan, John K ; Choi, Eunji ; Francoeur, Alex A ; Kapp, Daniel S ; Johnson, Caitlin R ; Tewari, Krishnansu S ; Liang, Su-Ying ; Brameld, Max ; File, Brittany

Background:

The purpose of this project was to evaluate the cost-effectiveness of novel FDA approved regimens incorporating immunotherapy into upfront treatment with chemotherapy in advanced or recurrent endometrial cancer in the mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) cohorts.

Methods:

Partitioned survival models were established based on the RUBY, NRG-GY 018, and DUO-E trials, as well as available FDA data. Incremental cost-effectiveness ratios (ICERs) were estimated based on quality adjusted progression free life years saved (QA-PFLYS). Tree Age software was used to perform partitioned survival modeling. Outcomes for dMMR and pMMR groups were compared based on the current FDA approvals. Costs were obtained from Redbook Micromedex pricing and adjusted for inflation from study activation to public dissemination of trial results.

Results:

The addition of pembrolizumab, dostarlimab, or durvalumab to chemotherapy in patients with dMMR tumors resulted in improvements in progression free life years saved. Based on QA-PFLYS, the ICER for pembrolizumab was $217,713, followed by $351,280 for durvalumab, and $451,750 for dostarlimab. When continuing durvalumab for 2 years, the ICER was $262,087. When looking at patients with pMMR tumors, the ICER for pembrolizumab was $250,535 while the ICER for dostarlimab was $1,349,776.

Conclusions:

Recognizing existing differences in study design, both pembrolizumab and durvalumab may be more cost effective than dostarlimab in our model. This appears to largely be driven by differences in duration of maintenance therapy rather than differences in effectiveness or individual drug cost. Immunotherapy does not appear to be as cost effective in the pMMR population.

01 Apr 2026·LUNG CANCER

Real-world comparative effectiveness of atezolizumab versus durvalumab for extensive-stage small-cell lung cancer

Article

Author: Yamamoto, Ryo ; Koshio, Jun ; Sakaguchi, Tadashi ; Takigami, Ayako ; Maemondo, Makoto ; Sugawara, Shunichi ; Hara, Shuichiro ; Sakashita, Hiroyuki ; Tominaga, Shinichiro ; Aiba, Tomoiki ; Ando, Yumi

BACKGROUND:

Both atezolizumab and durvalumab combined with platinum-etoposide have become standard first-line treatments for extensive-stage small-cell lung cancer (ES-SCLC), yet head-to-head real-world comparative data remain scarce.

METHODS:

We conducted a multicenter retrospective cohort study of 234 patients with ES-SCLC treated with atezolizumab plus platinum-etoposide (AEP; n = 126) or durvalumab plus platinum-etoposide (DEP; n = 108) across five Japanese institutions between 2016 and 2023. Progression-free survival (PFS) and overall survival (OS) were compared using Kaplan-Meier and overlap-weighted Cox models. Safety, a cost-effectiveness (cost-minimization) analysis based on restricted mean survival time-derived quality-adjusted life years (QALYs), and second-line treatment outcomes were also evaluated.

RESULTS:

Median PFS was 5.0 months for AEP and 5.1 months for DEP (hazard ratio [HR] 0.96; 95% CI, 0.73-1.26), and median OS was 12.0 and 12.1 months for AEP and DEP, respectively (HR 0.94; 95% CI, 0.68-1.31). Safety profiles were broadly equivalent between groups. Economic analysis showed nearly identical QALYs (1.002 vs 1.011) but lower total direct medical cost for AEP (¥4.14 million vs ¥4.88 million). Among 128 patients receiving second-line chemotherapy, those with platinum-sensitive relapse had significantly longer OS than those with platinum-refractory relapse, regardless of regimen.

CONCLUSIONS:

In real-world practice, AEP and DEP demonstrated equivalent efficacy and safety as first-line treatment for ES-SCLC. Given its lower cost with comparable QALYs, AEP may represent the more cost-minimizing option. The prognostic distinction between sensitive and refractory relapse remains clinically relevant after chemoimmunotherapy.

1,176

News (Medical) associated with Durvalumab

18 Mar 2026

·www.biospace.com

Guardant Health to Present 28 Abstracts Highlighting Advances in Tumor Typing, Therapy Selection and Expanded Utility of Multiomic Tissue and Liquid Biopsy Testing at AACR 2026

Guardant Reveal demonstrates expanded utility in identifying new, primary cancers during minimal residual disease (MRD) monitoring Studies show strong performance of Guardant360 Tissue in determining tissue of origin in diagnostically challenging settings PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present 28 abstracts, including 3 oral sessions, showcasing advances in methylation-based tumor classification and liquid biopsy technology at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California taking place April 17 - 22, 2026. Key data that will be presented include: An oral presentation of research data showing high accuracy of Guardant360 Tissue in determining tissue of origin with strong performance in cancers of unknown primary, correctly identifying the likely origin in approximately 92% of known cases across more than 6,000 tissue samples and 24 tumor types and supporting the clinical utility of methylation-based tumor typing for tissue samples in diagnostically challenging settings. An oral presentation showcasing the expanded utility of Guardant360 Liquid beyond basic genomic testing, highlighting the strength of its novel epigenomic features in increasing clinical actionability. Researchers found that Guardant360 Liquid demonstrated actionable findings for 85% of metastatic breast cancer patients and 89% of patients with advanced colorectal cancer. A real-world analysis evaluating the utility of Guardant Reveal to identify new primary malignancies during minimal residual disease (MRD) monitoring, demonstrating the potential to detect separate primary cancers in patients over time with non-invasive, liquid biopsy technology. Additional research bolstering the potential of Guardant360 Tissue in expanding access to targeted treatment options showing that a tissue-based genomic instability score (GIS) can accurately detect DNA repair deficiencies in breast, ovarian, and pancreatic cancers and accurately identifying patients who may benefit from PARP inhibitors. “The breadth of the data Guardant will be presenting demonstrate the power of our blood- and tissue-based tests in helping address critical gaps across cancer care,” said Dr. Craig Eagle, Chief Medical Officer at Guardant Health. “From identifying cancers of unknown primary and detecting new malignancies in tandem with MRD monitoring to expanding treatment options for more cancers, we are eager to present these findings along with our research collaborators at the AACR meeting and proud to offer innovative tests that are meeting today’s most complex challenges in cancer care.” Key Guardant Health and collaborator presentations at AACR 2026 Presentation Title Time / Location Monday, April 19 1316 A methylation-based molecular tumor typing classifier for tissue samples from cancers of unknown primary April 19, 2026 / 3:00 PM - 5:00 PM PT Tuesday, April 20 4016 Tissue-based homologous recombination deficiency status prediction in patients with breast, ovarian, and pancreatic cancers April 20, 2026 / 2:30 PM - 4:30 PM PT 2279 DNA methylation-based classifier predicts SERD benefit in ESR1 wild-type HR+/HER2- breast cancer April 20, 2026 / 9:00 AM - 12:00 PM PT Poster hall / Section 34 Wednesday, April 21 6512 Exploring clinical actionability of expanded liquid biopsy in advanced breast and colorectal cancers April 21, 2026 / 2:00 PM - 5:00 PM PT Poster Section 43 6512 Evaluating molecular tumor type predictions for identifying new primary malignancies - A real-world clinical genomics analysis April 21, 2026 / 2:00 PM - 5:00 PM PT Poster Section 43 CT230 STRIDE regimen of tremelimumab and durvalumab as non-operative management strategy of MSI-H resectable gastric or gastroesophageal junction adenocarcinoma (GAC/GEJAC): final results of the cohort 2 of INFINITY study by GONO GI April 21, 2026 / 10:15 AM – 12:15 PM PT The full abstracts for Guardant Health and a list of all abstracts being presented at the AACR Annual Meeting can be found here. About Guardant360 Guardant360 Liquid is a blood-based test that analyzes tumor DNA fragments circulating in the blood (cfDNA) to identify genetic mutations in advanced solid tumors, helping oncologists find targeted therapies. It offers an alternative to tissue biopsies, providing comprehensive genomic profiling (CGP) to guide personalized treatment for a wide range of solid cancers including lung, breast, colorectal, and prostate cancer. Guardant360 Liquid is guideline-complete across all advanced solid tumors, and has been clinically validated in more than 1,500 publications and research abstracts. About Guardant Reveal Guardant Reveal is a tissue-free liquid biopsy test that detects minimal residual disease (MRD) and monitors recurrence in early-stage colorectal, breast, and lung cancers, helping oncologists guide treatment decisions. In addition to MRD detection, Reveal can be used for late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights. The first clinical-validation study of pan-cancer chemotherapy monitoring published in The Journal of Liquid Biopsy showed that Guardant Reveal predicts long-term patient benefit up to 18 months earlier than standard clinical measures. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook . Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Contacts Investor Contact: Zarak Khurshid investors@guardanthealth.com Media Contact: Meaghan Smith press@guardanthealth.com

Clinical ResultAACR

18 Mar 2026

·www.biospace.com

AIM ImmunoTech Announces Final Approval of Novel Cancer Therapy Patent in Japan Combining Ampligen with Checkpoint Inhibitors

AIM also intends to pursue Japanese Orphan Drug Designation for Ampligen in treatment of pancreatic cancer OCALA, Fla., March 18, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the Japan Patent Office has fully approved a Japanese patent covering the Company’s proprietary use of Ampligen (rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer. The patent was granted in September 2025, but had to then pass a 6-month opposition period. Japan is one of the largest health markets in the world, with Japan and the United States expected to experience the greatest increase in global pancreatic cancer burden by 2030. The Japan patent expires December 20, 2039. The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad and encompass multiple cancer types – including pancreatic cancer. AIM also holds a U.S. patent (expires August 9, 2039) for methods involving the use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). AIM CEO Thomas K. Equels stated: “AIM is committed to developing Ampligen for the treatment of late-stage pancreatic cancer, which is an extremely lethal and unmet global health problem. Securing this critical patent in a key global market is just the latest step in AIM’s robust development and commercialization strategy.” AIM also intends to expand its intellectual property portfolio by pursuing orphan drug designation in Japan for Ampligen in the treatment of pancreatic cancer. The Company already holds Orphan Drug designations for pancreatic cancer in the United States and the European Union. While the details of the designations vary by region, the purpose is to incentivize the development of therapies for unmet health needs, by providing various benefits and market exclusivity after a drug receives market approval. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen ® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials. Forward-Looking Statements Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in the press release speak only as of the date of the press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The Company is in various stages of seeking to determine whether Ampligen ® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and disclosures in the Company’s reports filed with the SEC on its website and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen ® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen ® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website and in its press releases. No assurance can be given that intention to seek Orphan Drug Designation will result in the granting of that status, nor that the possession of Orphan Drug Designations or any patents means that a drug will receive market approval. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks. Please review the “Risk Factors” section in the Company’s latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and the Registration Statement. Its filings are available at The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only. CONTACT: Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com

Orphan DrugClinical StudyImmunotherapy

16 Mar 2026

·firstwordpharma.com

AstraZeneca's Imfinzi regimen wins EU clearance in perioperative gastric cancer setting

AstraZeneca said Monday that its PD-L1 inhibitor Imfinzi (durvalumab) gained approval in the EU for the treatment of adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. The clearance — for use alongside standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin and docetaxel) chemotherapy — follows a similar authorisation in the US late last year."This approval marks our third perioperative approval in Europe for an Imfinzi-based regimen," said Dave Fredrickson, EVP of AstraZeneca's oncology haematology business unit. "For patients with early gastric and gastroesophageal cancers, this immunotherapy-based regimen delivers a durable survival benefit that increases over time."The approval, following a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) earlier this year, is based on findings from the Phase III MATTERHORN trial. In an interim analysis of the study, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone.Meanwhile, the final overall survival analysis showed that 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. An estimated 69% of patients treated with the Imfinzi-based regimen were alive at three years compared with 62% in the comparator arm. AstraZeneca noted that the latest EU approval includes two cycles of Imfinzi in combination with chemotherapy before and after surgery, followed by Imfinzi monotherapy. A marketing application is currently under review in Japan for this indication.

Drug ApprovalClinical ResultImmunotherapyPhase 3

100 Deals associated with Durvalumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10808	Durvalumab	L01XC28	DB11714

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	European Union	AstraZeneca AB	16 Mar 2026
Gastroesophageal junction adenocarcinoma	Iceland	AstraZeneca AB	16 Mar 2026
Gastroesophageal junction adenocarcinoma	Liechtenstein	AstraZeneca AB	16 Mar 2026
Gastroesophageal junction adenocarcinoma	Norway	AstraZeneca AB	16 Mar 2026
Stomach Cancer	European Union	AstraZeneca AB	16 Mar 2026
Stomach Cancer	Iceland	AstraZeneca AB	16 Mar 2026
Stomach Cancer	Liechtenstein	AstraZeneca AB	16 Mar 2026
Stomach Cancer	Norway	AstraZeneca AB	16 Mar 2026
Early gastric cancer	United States	AstraZeneca PLC	25 Nov 2025
Gastrooesophageal junction cancer	United States	AstraZeneca PLC	25 Nov 2025
Locally Advanced Gastric Carcinoma	United States	AstraZeneca PLC	25 Nov 2025
Unresectable Lung Non-Small Cell Carcinoma	China	AstraZeneca UK Ltd.	18 Nov 2025
Muscle Invasive Bladder Carcinoma	United States	AstraZeneca UK Ltd.	28 Mar 2025
Uterine Neoplasms	Japan	AstraZeneca Pharmaceuticals Co. Ltd.	22 Nov 2024
Advanced Endometrial Carcinoma	European Union	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Iceland	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Liechtenstein	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Norway	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	European Union	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Iceland	AstraZeneca AB	15 Aug 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
ALK positive Non-Small Cell Lung Cancer	NDA/BLA	China	AstraZeneca AB	21 Feb 2025
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	AstraZeneca UK Ltd.	21 Feb 2025
Ovarian Epithelial Carcinoma	NDA/BLA	China	AstraZeneca UK Ltd.	16 Aug 2024
PD-L1 positive Triple Negative Breast Cancer	Phase 3	United States	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	China	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Japan	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Argentina	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Australia	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Brazil	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Canada	AstraZeneca PLC	23 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03694236 (AACR2026)	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	30	Neoadjuvant durvalumab combined with concurrent chemoradiotherapy	tzxkfhhkts(kduicxgbzy) = jfkpjtjvzp fzijzyysrk (urgksqqoaw ) View more	Positive	22 Apr 2026
NCT05640791 (DURGAP, AACR2026)	Phase 2	Biliary Tract Neoplasms Neoadjuvant CD8+ \| CD4+ \| regulatory T cells (Tregs)	8	Neoadjuvant DurGAP therapy (TRG1)	eexokbyalu(xgemzgrffh) = sfkgnehxzs rqyxuwwpob (yupjjjqdqc ) View more	Positive	22 Apr 2026
NCT03820141 (AACR2026)	Phase 2	HER2 Positive Breast Cancer ER-negative \| PR-negative \| HER2-Enriched	37	durvalumab+trastuzumab+pertuzumab	huzsuxptwr(wrsdgmczba) = jgkgsxdhqe izbcswudaw (benzlasnsr )	Positive	21 Apr 2026
NCT06526104 (STRIDE in CP-B, AACR2026)	Phase 2	Hepatocellular Carcinoma First line	30	Tremelimumab 300 mg + Durvalumab 1500 mg (Hepatocellular Carcinoma + Child-Pugh B cirrhosis)	yjdlbzdeaj(dnrfjanrqk) = uqxqtrfnlc cwgxlcvcvq (syajfvywoq ) View more	Positive	21 Apr 2026
NCT04308174 (DEBATE, AACR2026)	Phase 2	Biliary Tract Neoplasms Neoadjuvant	45	Durvalumab plus Gemcitabine-Cisplatin (D+GP)	gzkaujxtox(vygjgdcyro) = tlugdhdohs bavlqmvrlq (wazhadbjqn ) View more	Positive	21 Apr 2026
				Gemcitabine-Cisplatin (GP)	gzkaujxtox(vygjgdcyro) = ulypicvksc bavlqmvrlq (wazhadbjqn ) View more
AACR2026	Phase 2/3	Bladder Cancer First line	200	ICI-only regimen(Durvalumab, Durvalumab+Tremelimumab, Pembrolizumab)	qxbfuvjlwg(hszddpikue): HR = 1.92 (95.0% CI, 1.63 - 2.25) View more	Negative	21 Apr 2026
				chemotherapy
IMforte (AACR2026)	Phase 3	Extensive stage Small Cell Lung Cancer Maintenance	452	Lurbinectedin plus atezolizumab	mqjqmkdcxn(ptumjsskjg) = laatyxpoqm ngemyenkfa (apdqmtougp ) View more	Positive	20 Apr 2026
				Durvalumab	mqjqmkdcxn(ptumjsskjg) = xqodavrvxy ngemyenkfa (apdqmtougp ) View more
NCT04637594 (IMAGINE, CTgov)	Phase 3	Urothelial Carcinoma of the Urinary Bladder \| Metastatic Urethral Urothelial Carcinoma \| Locally Advanced Urothelial Carcinoma ... View more	3	Nivolumab+Avelumab+Atezolizumab+Pembrolizumab+Durvalumab (Arm A (Immune Checkpoint Inhibitor))	ivzavwukrj = ireotupqxe kaoyclzpsv (exmlgeqdqa, kjexgxoxjt - mpfwwbbaos) View more	-	20 Mar 2026
				Nivolumab+Avelumab+Atezolizumab+Pembrolizumab+Durvalumab (Arm B (Immune Checkpoint Inhibitor))	ivzavwukrj = lzsapcjrym kaoyclzpsv (exmlgeqdqa, zbflgjhhtb - fhigelsvum) View more
NCT04902040 (CTgov)	Phase 1/2	Melanoma, Cutaneous Malignant \| Advanced Malignant Solid Neoplasm \| Advanced Renal Cell Carcinoma ... View more	19	Plinabulin+Pembrolizumab+RTX (Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W))	asidpoqhbj = mdfcllgjun fjeuzxrjop (ibdbellzdr, mpoddensfb - sghpzlvzmp) View more	-	18 Mar 2026
				Nivolumab+Plinabulin+RTX (Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W))	asidpoqhbj = ufiumkqtbx fjeuzxrjop (ibdbellzdr, gpozdobhva - qkldlapulh) View more
NCT05844046 (MONTBLANC, Pubmed \| Ther Adv Med Oncol)	Phase 2	Unresectable Hepatocellular Carcinoma programmed cell death ligand 1 \| cytotoxic T-lymphocyte-associated antigen-4 \| vascular endothelial growth factor	168	Durvalumab + Tremelimumab + Bevacizumab	jzvtuzvnzw(kkcyqdmklf) = yrcuxfrtdx ardtjylqdg (yrwbnzytpq )	Positive	01 Mar 2026
				Durvalumab + Tremelimumab	ywoegzfina(xqiojsiljm) = fsanaurefb qkdwdfiitg (ffsfwnavkd ) View more

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