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Last update 16 Dec 2025

Durvalumab

Last update 16 Dec 2025

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

Early gastric cancerGastrooesophageal junction cancerLocally Advanced Gastric Carcinoma+ [192]

Inactive Indication

Acute Myeloid LeukemiaAdenocarcinoma of LungAdenocarcinoma of prostate+ [79]

Originator Organization

AstraZeneca UK Ltd.

Active Organization

AstraZeneca PLCAstraZeneca AB

MedImmune LLC

+ [18]

Inactive Organization

Circio Holding ASA

Plexxikon, Inc.

Fred Hutchinson Cancer Research Center

+ [6]

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

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

Structure/Sequence

Sequence Code 10069506H

Source: *****

Sequence Code 13384675L

Source: *****

893

Clinical Trials associated with Durvalumab

NCT07247786

/ Not yet recruitingPhase 2

Phase II Randomized Clinical Trial for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant (FMT) in Stage II-III Non-small Cell Lung Cancer (NSCLC) Patients, Using Immune Checkpoint Inhibitors (ICI) Responders as Donors.

This is a randomized, phase II, multi-centre clinical trial.
Sample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients)
Population: Patients with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer
In the Experimental arm, patients will receive Fecal Microbiota Transplant. Once done, the patient will start neoadjuvant treatment with Durvalumab + Chemotherapy .
In the Control arm, patients will receive neoadjuvant treatment with Durvalumab + Chemotherapy.
After neoadjuvant/induction treatment every patient will be evaluated to decide if the patient is a candidate for surgery or not. Patients that are R0 after surgery will receive Adjuvant treatment with Durvalumab.
The primary objective is to evaluate the pathological Complete Response (pCR) rate.
The total trial duration will be 6.5 years approximately.

Start Date15 Mar 2026

Sponsor / Collaborator

Fundacion GECP

NCT07107750

/ Not yet recruitingPhase 1IIT

Phase I Trial of CA-4948 in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer

Based on preclinical data from the Lim lab (WUSM), the investigators hypothesize that IRAK4 inhibition cripples tumor-intrinsic survival signaling and effectively overcomes the desmoplastic and immune-suppressive tumor microenvironment (TME) to render chemo- and immunotherapies effective in GI malignancy. Therefore, this trial is designed to evaluate the combination of CA-4948 and standard chemoimmunotherapy in untreated advanced or metastatic biliary tract cancer.

Start Date28 Feb 2026

Sponsor / Collaborator

Washington University School of Medicine

[+1]

NCT07226063

/ Not yet recruitingPhase 2IIT

A Phase II Study of Maintenance Zanzalintinib and Durvalumab in Patients With Advanced Hepatocellular Cancer After Induction Tremelimumab Plus Durvalumab

This research study is for people who were treated with tremelimumab and durvalumab for advanced liver cancer and who are currently receiving durvalumab. Participants in this study will receive a drug called zanzalintinib. They will also continue receiving durvalumab. Studies have shown that patients with advanced liver cancer who had tremelimumab and durvalumab may benefit from taking zanzalintinib while they are taking durvalumab. Zanzalintinib is an investigational drug. This means it has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced liver cancer. Durvalumab is approved by the FDA for patients with advanced liver cancer. The purpose of this study is to find out if taking zanzalintinib with durvalumab will improve how long people with advanced liver cancer will live.

Start Date01 Feb 2026

Sponsor / Collaborator

The Case Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Durvalumab

100 Translational Medicine associated with Durvalumab

100 Patents (Medical) associated with Durvalumab

2,265

Literatures (Medical) associated with Durvalumab

01 Jan 2026·Journal of Clinical and Experimental Hepatology

Variceal Bleeding Due to Single-tremelimumab Regular-interval Durvalumab: Immunotherapy Induced or Cirrhosis Driven?

Letter

Author: Ankam, Vamshi K ; Priya, Srujana ; Sharma, Mithun ; Reddy, Duvvur N ; Rao, Padaki N ; Khan, Arif M ; Tandon, Manu ; Kulkarni, Anand V

31 Dec 2025·Human Vaccines & Immunotherapeutics

From PD-1/PD-L1 to tertiary lymphoid structures: Paving the way for precision immunotherapy in cholangiocarcinoma treatment

Review

Author: Fang, Ye-Ying ; Huang, Fang-Ju ; Chen, Gang ; He, Rong-Quan ; Su, Qin-Yan ; Wen, Jia-Ying ; Li, Jian-Jun ; Qin, Di-Yuan ; Chi, Bang-Teng ; Chen, Yi-Yang ; Zeng, Jian-Jia ; Wang, Lei ; Yang, Li-Hua ; Lin, Qian

Cholangiocarcinoma (CCA) is a highly malignant hepatobiliary tumor characterized by limited treatment options and poor prognosis. The recent rise of immunotherapy has significantly influenced research in this field. This study presents a bibliometric analysis of 416 articles retrieved from the WOSCC, Wan fang Data, CNKI and VIP databases, spanning contributions from 32 countries, 589 institutions and 3,200 authors. The analysis identified "PD-L1," "PD-1" and "pembrolizumab" as central research foci, while "immune checkpoint inhibitors," "tumor immune microenvironment," "tertiary lymphoid structures" and "durvalumab" emerged as key areas of interest. These findings emphasize the pivotal role of immunotherapy in improving survival outcomes for CCA, and they highlight the significance of tertiary lymphoid structures within the tumor microenvironment as a promising target for future research. This study offers a strategic overview of the evolving landscape of CCA immunotherapy, providing valuable insights to guide future scientific endeavors in this domain.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of perioperative nivolumab + neoadjuvant platinum doublet chemotherapy as treatment for resectable non-small cell lung cancer in the United States

Article

Author: Milev, Sandra ; White, Benjamin ; Sun, Ariel ; Harris, Mack ; Lucherini, Stefano ; Villacorta, Reginald

AIMS:

CheckMate-77T demonstrated the clinical benefit of perioperative nivolumab plus neoadjuvant platinum-doublet chemotherapy (periNivo + neoCT). This study assessed the cost-effectiveness of periNivo + neoCT as treatment for non-metastatic (Stage IIA-IIIB), resectable non-small cell lung cancer (NSCLC) vs. relevant comparators in the US.

MATERIALS AND METHODS:

Following the natural history of non-metastatic NSCLC, a four-state Markov model was developed. Modeled health states were event-free survival, locoregional recurrence, distant metastasis, and death. CheckMate-77T informed time to progression estimates for periNivo + neoCT and neoCT; mortality estimates leveraged longer-term follow-up available from CheckMate-816. Indirect treatment comparison informed efficacy of comparator treatments not considered in CheckMate-77T. Comparators were neoadjuvant treatment strategies (neoadjuvant nivolumab + chemotherapy [neoNivo + CT], neoadjuvant chemotherapy [neoCT], and neoadjuvant chemoradiotherapy [neoCRT]), adjuvant chemotherapy (adjCT), and perioperative immuno-therapy (IO) strategies (perioperative durvalumab + neoadjuvant chemotherapy [periDurva + neoCT] and perioperative pembrolizumab + neoadjuvant chemotherapy [periPembro + neoCT]). Cost inputs were obtained from published literature and standard US sources and expressed in 2024 USD. The base-case analysis adopted the perspective of a commercial payer with a lifetime time horizon and discounted cost and health outcomes by 3% annually.

RESULTS:

Model results showed that periNivo + neoCT is more effective and costly than comparators. Deterministic incremental cost-effectiveness ratios were $84,921, $153,557, $77,976, $60,826, $74,252, $32,069, and $21,974 vs. neoCT, neoNivo + CT, neoCRT, adjCT, surgery, periPembro + neoCT, and periDurva + neoCT, respectively. In probabilistic sensitivity analysis, periNivo + neoCT resulted in an ICER below $150,000/QALY in 93.3%, 58.2%, 82.4%, 95.1%, 98.3%, 69.9%, and 82.1% of iterations vs. neoCT, neoNivo + CT, neoCRT, adjCT, surgery only, periPembro + neoCT, and periDurva + neoCT, respectively.

LIMITATIONS:

Uncertainty in the survival extrapolations reflected the limited body of evidence informing the indirect treatment comparison. ICERs vs. perioperative IO treatment strategies were sensitive to small changes in predicted costs and QALYs, given low incremental base case costs and QALYs.

CONCLUSION:

PeriNivo + neoCT is a cost-effective treatment option for patients with resectable, non-metastatic NSCLC.

1,120

News (Medical) associated with Durvalumab

16 Dec 2025

·www.prnewswire.com

Immunotherapy Breakthroughs Turn Cold GI Tumors Hot as Market Tops $443B

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 16, 2025 /PRNewswire/ -- USANewsGroup.com News Commentary – Gastrointestinal cancers that once resisted checkpoint inhibitors are finally responding to novel combination strategies[1], with the FDA fast-tracking multiple targeted therapies designed to transform immunologically cold tumors into treatment-responsive hot targets[2]. This pivotal shift positions Oncolytics Biotech Inc. (NASDAQ: ONCY), AIM ImmunoTech (NYSE-American: AIM), ArriVent BioPharma, Inc. (NASDAQ: AVBP), Merus N.V. (NASDAQ: MRUS), and Halozyme Therapeutics, Inc. (NASDAQ: HALO) as potential leaders in the battle against stolid tumors, including gastrointestinal cancers. The global cancer immunotherapy market is projected to reach $443.17 billion by 2030, growing at 11.90% annually as regulators accelerate approvals for therapies that activate immune responses in historically resistant gastrointestinal malignancies[3]. Institutional capital flows reflect surging confidence in immunotherapy platforms and bispecific antibody combinations, with oncology capturing 53 deals from 115 investors in Q2 2025 alone as the sector races to overcome the immunosuppressive tumor microenvironments that have made first-line GI cancer immunotherapy one of oncology's most challenging frontiers[4]. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced promising efficacy and translational data supporting pelareorep in KRAS-mutant metastatic colorectal cancer, achieving a 33% objective response rate in second-line patients with microsatellite-stable disease who received pelareorep, Avastin, and FOLFIRI. This represents triple the historical response rate of 6-11% for Avastin plus FOLFIRI in this setting. The data strengthen pelareorep's potential across gastrointestinal tumors, building on recent anal cancer results showing a 30% response rate in second-line squamous cell anal carcinoma, more than double the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for current standard care, with two durable complete responses among responders. Translational analysis revealed that pelareorep treatment led to notable increases in KRAS-mutant-specific T-cell populations, providing mechanistic support for the clinical activity observed in this genetically defined patient population. These findings position pelareorep as a precision immunotherapy capable of providing a meaningful clinical benefit over the current standard of care. "Colorectal cancer is the core of our emerging GI tumor platform strategy for pelareorep, with a projected total addressable market of $20 billion by 2033," said Jared Kelly, CEO of Oncolytics Biotech. "Pelareorep has clearly demonstrated the potential to become a transformational new treatment option in this underserved setting. With translational data supporting its unique activation of KRAS-specific T cells, pelareorep has delivered a 33 percent response rate in KRAS-mutant, MSS colorectal cancer." The company plans to sponsor a controlled study in second-line KRAS-mutant MSS colorectal cancer following consultation with key opinion leaders and regulatory authorities, providing analytical rigor to support potential regulatory submissions. This will enable Oncolytics to have control over the data generated from this study and update relevant stakeholders at their discretion, including investors and potential partners. "These results are extremely encouraging," said Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey. "Achieving a 33% ORR in KRAS-mutant MSS colorectal cancer is highly unusual in this setting and warrants immediate further study." The company recently established a Gastrointestinal Tumor Scientific Advisory Board to guide registration strategy across pancreatic, colorectal, and anal cancers. Inaugural members include Dr. Goel, Dr. Deva Mahalingam from Northwestern University, and Dr. Dirk Arnold, principal investigator of the GOBLET study. Oncolytics has also secured FDA alignment on its pivotal Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning the company to launch the only immunotherapy registration trial currently planned for this disease. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer. CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson, demonstrating proven ability to advance assets through value-creating transactions. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: AIM ImmunoTech (NYSE-American: AIM) has reported positive clinical progress in its ongoing DURIPANC clinical trial combining Ampligen and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi for metastatic pancreatic cancer. The company reported Q3 2025 research and development expenses of approximately $607,000, compared to $1.4 million in the prior year period, while maintaining a focused monthly burn rate of approximately $550,000. "The third quarter was marked by solid and positive clinical and operational execution," said Thomas K. Equels, CEO of AIM ImmunoTech. "Our clinical, manufacturing and regulatory teams are heavily focused on moving Ampligen down a pathway toward eventual FDA approval as part of a combination therapy for pancreatic cancer." The company expects to release a year-end update from the DURIPANC trial by the end of the current quarter. AIM ImmunoTech reported cash, cash equivalents and marketable investments of $2.4 million as of September 30, 2025, with a net loss of $3.3 million or $1.57 per share for Q3 2025. ArriVent BioPharma, Inc. (NASDAQ: AVBP) presented final Phase 1b data at the 2025 World Conference on Lung Cancer, demonstrating clinically meaningful outcomes for firmonertinib in EGFR PACC mutant non-small cell lung cancer, advancing two global Phase 3 pivotal studies across uncommon EGFR mutations. The company maintained $305.4 million in cash and investments as of September 30, 2025, supporting operations into mid-2027, while receiving FDA IND clearance for ARR-217, a CDH17-targeted antibody-drug conjugate for gastrointestinal cancers. "Our late-stage firmonertinib program continues to make strong progress across EGFR-mutant NSCLC populations, with two global Phase 3 pivotal studies being conducted in uncommon EGFR mutant non-small cell lung cancer," said Bing Yao, CEO of ArriVent. "Following our strong Phase 1b findings, we are advancing to pivotal development with enrollment of the first patient in our global pivotal Phase 3 trial for PACC mutant NSCLC expected in the fourth quarter of this year. Additionally, we project topline pivotal data from our global Phase 3 trial in exon 20 insertion mutant NSCLC in early 2026, a patient population for which firmonertinib received FDA Breakthrough Therapy Designation." The ALPACCA Phase 3 study expects to enroll its first patient in Q4 2025 for first-line PACC mutant NSCLC, while the FURVENT Phase 3 trial targeting exon 20 insertion mutations projects topline data in early 2026. ArriVent also appointed Brent S. Rice as Chief Commercial Officer to establish commercial leadership ahead of potential regulatory milestones. Merus N.V. (NASDAQ: MRUS) and Halozyme Therapeutics, Inc. (NASDAQ: HALO) entered a global collaboration to develop a subcutaneous formulation of petosemtamab using Halozyme's ENHANZE® drug delivery technology. Petosemtamab, an EGFR x LGR5 bispecific antibody, continues to show encouraging results across numerous solid tumor cancers with the potential to become a first-in-class treatment for head and neck cancer. "We are excited to collaborate with Merus to advance treatment options for patients with r/m HNSCC and other potential indications," said Dr. Helen Torley, CEO of Halozyme. "This collaboration represents a new opportunity for our ENHANZE® technology to improve treatment efficiency and enhance the patient treatment experience." Under the agreement terms, Merus will make an upfront payment to Halozyme plus potential future milestone payments related to commercial and sales attainment. Halozyme will be entitled to up to low-mid single digit royalties on net sales of petosemtamab formulated with the ENHANZE® technology during the royalty term. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: 1. 2. 3. 4. Logo - 21% more press release views with Request a Demo

Phase 3Phase 1ImmunotherapyClinical ResultBreakthrough Therapy

15 Dec 2025

·www.astrazeneca.com

Enhertu plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test. The approval follows Priority Review and Breakthrough Therapy Designation by the FDA and is based on the results of the DESTINY-Breast09 Phase III trial. The data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.1 Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology, Dana-Farber Cancer Institute and principal investigator for the trial, said: “Trastuzumab deruxtecan plus pertuzumab is the only 1st-line treatment approved in more than a decade to demonstrate a statistically significant improvement in progression-free survival over the current standard regimen for patients with HER2-positive metastatic breast cancer. With a median progression-free survival exceeding three years, versus approximately two years with THP, trastuzumab deruxtecan combined with pertuzumab should become a new 1st-line standard of care in this setting.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “With this approval, we are bringing Enhertu to the earliest setting for HER2-positive metastatic breast cancer, where optimising efficacy has an important impact on long‑term outcomes. The treatment approach with Enhertu plus pertuzumab in DESTINY-Breast09 sets a new benchmark of more than three years without disease progression or death for patients in this setting.” Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, said: “Since its initial approval six years ago, Enhertu has transformed the treatment of HER2-positive metastatic breast cancer. With this approval of Enhertu in the 1st-line HER2-positive metastatic setting, Enhertu once again offers significant improvements in progression-free survival and has practice-changing potential when used in combination with pertuzumab.” In the trial, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95% confidence interval [CI] 0.44-0.71; p<0.0001) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer. Median progression-free survival (PFS) was 40.7 months with Enhertu plus pertuzumab compared to 26.9 months for THP. The PFS benefit for Enhertu plus pertuzumab versus THP was consistent across subgroups.1 The safety profile of Enhertu plus pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual therapy with no new safety concerns identified. Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. This application was approved under the FDA’s Real-Time Oncology Review (RTOR), an initiative by the FDA to ensure safe and effective treatments are available to patients as early as possible. This US regulatory submission was also reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, the Enhertu plus pertuzumab 1st-line regimen is under review by Switzerland’s Swissmedic (SMC) and Singapore's Health Sciences Authority (HSA). Separate regulatory applications are also under review in other countries. Financial considerations Following this approval in the US, an amount of $150m is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the 1st-line unresectable or metastatic HER2-positive breast cancer indication. Sales of Enhertu in the US are recognised by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019. Notes HER2-positive metastatic breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.2 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.2 In the US, more than 300,000 cases of breast cancer are diagnosed annually with more than 42,000 deaths.3 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.4 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.5 HER2 protein overexpression may occur as a result of HER2 gene amplification.6 Approximately one in five cases of breast cancer are considered HER2-positive.7 HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2.8 Approximately 10,000 patients are treated each year in the 1st-line HER2-positive metastatic setting in the US.9 While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of 1st-line treatment with THP, which has been the standard of care for more than a decade.6,10-12 Approximately 25% to 30% of patients do not receive any treatment following 1st-line therapy due to discontinuation or death.13-15 DESTINY-Breast09 DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as a 1st-line treatment in patients with HER2-positive metastatic breast cancer. Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded-independent central review in the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov. Enhertu Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test based on the results from the DESTINY-Breast09 trial. Enhertu (5.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4mg/kg) is approved in more than 55 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (5.4mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu development programme A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in patients with HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP2-directed ADC, Datroway (datopotamab deruxtecan), and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). 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 Oncology Corporate and financial

Phase 3Drug ApprovalASCOLicense out/inClinical Result

10 Dec 2025

·www.globenewswire.com

AIM ImmunoTech Announces Release of the Next CEO Corner Segment

Tom Equels, CEO of AIM ImmunoTech, discusses the unmet need and driving Ampligen forward in pancreatic cancerOCALA, Fla., Dec. 10, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the next CEO Corner segment has been published on the Company’s website. In this latest CEO Corner segment, AIM Chief Executive Officer Thomas Equels discusses the unmet need in pancreatic cancer and the Company’s lead program, Ampligen® (rintatolimod), and its ongoing evaluation in the DURIPANC Phase 1b/2 clinical trial in combination with AstraZeneca’s Imfinzi® (durvalumab). The CEO Corner segment is now available here. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook. Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com

Immunotherapy

100 Deals associated with Durvalumab

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KEGG	Wiki	ATC	Drug Bank
D10808	Durvalumab	L01XC28	DB11714

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
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
Recurrent Endometrial Cancer	Liechtenstein	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Norway	AstraZeneca AB	15 Aug 2024
Resectable Lung Non-Small Cell Carcinoma	United Kingdom	AstraZeneca PLC	09 Jul 2024
Advanced biliary tract cancer	United States	AstraZeneca UK Ltd.	14 Jun 2024
Mismatch repair-deficient Endometrial Carcinoma	United States	AstraZeneca UK Ltd.	14 Jun 2024
Non-small cell lung cancer stage III	United States	AstraZeneca UK Ltd.	14 Jun 2024
Advanced Hepatocellular Carcinoma	European Union	AstraZeneca AB	14 Apr 2023
Advanced Hepatocellular Carcinoma	Iceland	AstraZeneca AB	14 Apr 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	NDA/BLA	Australia	AstraZeneca Pty Ltd.	11 Jun 2025
Stomach Cancer	NDA/BLA	Australia	AstraZeneca Pty Ltd.	11 Jun 2025
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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03298451 (HIMALAYA, ESMO_ASIA2025)	Phase 3	Unresectable Hepatocellular Carcinoma	321	Tremelimumab + Durvalumab	mionccptvq(rhvdxedgaj) = fyxjnfrsbt lfdgnfcrfa (gecgsskvxc, 14.46 - 33.35) View more	Positive	05 Dec 2025
				Durvalumab	mionccptvq(rhvdxedgaj) = zwdjoaqijn lfdgnfcrfa (gecgsskvxc, 15.84 - 23.85) View more
NCT07081633 (TREMENDOUS-2, ESMO_ASIA2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line	114	Lenvatinib+durvalumab+tremelimumab	aorcqkgolr(axklnvdbzi) = unxtkaxpcn fqaayrybna (pjymvhbfbs ) View more	Positive	05 Dec 2025
NCT04308174 (DEBATE, ESMO_ASIA2025)	Phase 2	Biliary Tract Neoplasms Neoadjuvant	45	Neoadjuvant durvalumab+gemcitabine-cisplatin	fdhijnitkp(aibssonpco) = rhwppvurcq sylzharoya (sbhqotkhji ) View more	Positive	05 Dec 2025
				Neoadjuvant gemcitabine-cisplatin	fdhijnitkp(aibssonpco) = dlactxnfuv sylzharoya (sbhqotkhji ) View more
ESMO_ASIA2025	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR mutation	51	durvalumab consolidation (EGFRm)	tmynujgfcy(fvanhbtdfj) = ifgvvmipdd szsykpbcjc (egdqzxfzra ) View more	Positive	05 Dec 2025
				durvalumab consolidation (EGFR-negative)	tmynujgfcy(fvanhbtdfj) = dgtnajrtnd szsykpbcjc (egdqzxfzra ) View more
ESMO_ASIA2025	Not Applicable	Recurrent Non-Small Cell Lung Cancer Consolidation PD-L1 expression	118	Platinum doublet plus ICIs	wzxrsumwsl(dgphpvoodl) = prllpvwxbh jkkkoqvvbx (xhgfxswzup, 7.1 - 14.8) View more	Positive	05 Dec 2025
				Platinum doublet	wzxrsumwsl(dgphpvoodl) = hkfrhhxcep jkkkoqvvbx (xhgfxswzup, 4.1 - 6.5) View more
ACTRN12621000586819 (CHEST-RT, ESMO_ASIA2025)	Phase 2	Extensive stage Small Cell Lung Cancer Consolidation	30	Consolidation thoracic radiation (TRT) + chemo-immunotherapy	pybnnvnauh(odshmbmpuj) = aefykxwkoq mneuqvexsc (xivspychmc ) View more	Positive	05 Dec 2025
ACTRN12621001225808 (ESMO_ASIA2025)	Phase 2	Small Cell Carcinoma First line	6	Durvalumab + Chemotherapy	jgcjxgsxji(zftcvbehfu) = syhndvjdjk borvplzlgq (vcossxvcmx, 1 - 52) View more	Negative	05 Dec 2025
NCT04999969 (CTgov)	Phase 2	Locally Advanced Malignant Solid Neoplasm	126	Nab-paclitaxel+AZD0171+Gemcitabine+Durvalumab	tdrnrpfjof = ssolwwfrtq awjrozhjic (ljdxhjywky, zqsxvktheh - tfeenotowc) View more	-	26 Nov 2025
NCT04592913 (MATTERHORN, Company_Website) Manual	Phase 3	Gastrooesophageal junction cancer \| Stomach Cancer	948	durvalumab + FLOT chemotherapy	geklscphip(hcpzbwxeqi) = tmntjfdbel zhnyfmfhme (vfmuqudyhn ) View more	Positive	25 Nov 2025
				Placebo + FLOT chemotherapy	geklscphip(hcpzbwxeqi) = nxuzhmdogx zhnyfmfhme (vfmuqudyhn ) View more
NCT03801369 (AMTEC, CTgov)	Phase 2	Metastatic breast cancer \| Metastatic Triple-Negative Breast Carcinoma	24	Quality-of-Life Assessment+Olaparib+Durvalumab (Arm I (olaparib, durvalumab))	fovwqjhuue = dedaiupjvn gkywtuymyq (epovzhsjsj, cyhmovwvwu - mcrmkiwdav) View more	-	21 Nov 2025
				Quality-of-Life Assessment+Olaparib+selumetinib (Arm II (olaparib, selumetinib))	qmsffbpgsa(uysrevzilc) = nzcgcjsonk spsngrdgjq (mfmqiftujr, eqkdlawjbc - fkjzgcgowx) View more

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