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Last update 07 Oct 2025

Durvalumab

Last update 07 Oct 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

Muscle Invasive Bladder CarcinomaUterine NeoplasmsAdvanced Endometrial Carcinoma+ [194]

Inactive Indication

Acute Myeloid LeukemiaAdenocarcinoma of LungAdenocarcinoma of prostate+ [75]

Originator Organization

AstraZeneca UK Ltd.

Active Organization

AstraZeneca PLC

AstraZeneca Investment (China) Co. Ltd.

MedImmune LLC

+ [17]

Inactive Organization

Fred Hutchinson Cancer Research Center

Plexxikon, Inc.

Mirati Therapeutics, Inc.

+ [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

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

Structure/Sequence

Sequence Code 10069506H

Source: *****

Sequence Code 13384675L

Source: *****

886

Clinical Trials associated with Durvalumab

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]

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 Date31 Dec 2025

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

NCT07172412

/ Not yet recruitingPhase 2IIT

An Umbrella Ib/II Phase Study Evaluating the Efficacy and Safety of First-Line Combination Therapy in the Treatment of Extensive-Stage Small Cell Lung Cancer

This is an open-label umbrella study conducted in first treatment ES-SCLC patients, employing a novel umbrella trial design (biomarker-integrated multi-arm trial with a shared ICI+chemotherapy control arm). Eligible patients were assigned to trial arms based on biomarker expression levels. Biomarker subgroups were defined as: (1) High ASCL1/NEUROD1/DLL3 expression: DLL3-CAR-NK cells combined with ICI + etoposide + carboplatin (DLL3 group); (2) Myc overexpression: XPO1 inhibitor selinexor combined with ICI + etoposide + carboplatin (XPO1 group); (3) VIM/AXL high expression group treated with anlotinib combined with ICI + etoposide + carboplatin (anlotinib group).

Start Date01 Nov 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

100 Clinical Results associated with Durvalumab

100 Translational Medicine associated with Durvalumab

100 Patents (Medical) associated with Durvalumab

2,388

Literatures (Medical) associated with Durvalumab

31 Dec 2025·OncoImmunology

Avelumab induces greater Fc-Fc receptor-dependent natural killer cell activation and dendritic cell crosstalk compared to durvalumab

Article

Author: Makarov, Vladimir ; Srivastava, Raghvendra M ; Rupani, Amit ; Chan, Timothy A ; Osborne, Nicole

Several FDA-approved anti-PD-L1 (programmed cell death ligand-1) monoclonal antibodies (mAbs) are used to treat cancer. While these mAbs primarily target and intercept PD-L1:PD-1 inhibitory signaling in T-cells, the Fc-domains of these mAbs are distinct, and the unique cellular cascades triggered by differing Fc-domains of PD-L1 mAbs have not been directly investigated. In this study, we compared the innate immune effects of two widely used anti-PD-L1 IgG1 mAbs which bear distinct Fc-domains, avelumab (native-Fc) and durvalumab (mutated-Fc), using two-cell and three-cell co-culture systems containing Natural Killer cells (NK-cells), dendritic cells (DCs) and various tumor cell lines of multiple cancer origins. We show a robust enhancement in NK-cell effector function, DC maturation, reciprocal NK:DC crosstalk and DC editing that is unique to avelumab treatment using multiple functional immune assays. By transcriptomic analysis, we show for the first time pivotal differences in gene sets involved in NK-cell effector function, DC maturation, immunoregulatory interactions, and cytokine production between innate immune cells treated with avelumab versus durvalumab. Furthermore, we report several previously unknown Fc-receptor-associated biological pathways uniquely triggered by avelumab. Our findings elucidate novel mechanisms of Fc-dependent actions of PD-L1 mAbs which may inform their use in future clinical trials.

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.

1,071

News (Medical) associated with Durvalumab

06 Oct 2025

·www.astrazeneca.com

Datroway demonstrated statistically significant and clinically meaningful improvement in overall survival as 1st-line therapy for patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option in TROPION-Breast02

Positive high-level results from the TROPION-Breast02 Phase III trial showed Datroway (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator's choice of chemotherapy as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option. Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including all patients whose tumours do not express PD-L1 as well as patients with PD-L1 expressing tumours who cannot receive immunotherapy due to other factors.1 Chemotherapy remains the 1st-line standard of care for these patients.2 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “TROPION-Breast02 is the only trial ever to show an overall survival benefit in the first-line treatment of patients with metastatic triple-negative breast cancer for whom immunotherapy is not an option. We expect today’s results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options.” Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “Datroway is the first antibody drug conjugate and the only therapy to significantly improve overall survival compared to chemotherapy in patients with metastatic triple-negative breast cancer for whom immunotherapy is not an option. These landmark results from TROPION-Breast02 strengthen our confidence in our ongoing clinical development programme for Datroway in triple-negative breast cancer and other tumour types. We look forward to discussing these data with global regulatory authorities and to bringing Datroway to patients with triple-negative breast cancer as soon as possible.” The safety profile of Datroway was consistent with previous clinical trials of Datroway in breast cancer. These data will be presented at an upcoming medical meeting and shared with regulatory authorities. Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. AstraZeneca and Daiichi Sankyo are evaluating Datroway across stages and treatment settings of TNBC in three additional Phase III trials. TROPION-Breast03 is evaluating Datroway with or without Imfinzi (durvalumab) in patients with Stage I-III TNBC with residual invasive disease after neoadjuvant systemic therapy. TROPION-Breast04 is evaluating neoadjuvant Datroway plus Imfinzi in patients with Stage II-III triple-negative or hormone receptor (HR)-low, HER2-low or -negative breast cancer. TROPION-Breast05 is evaluating 1st-line Datroway with or without Imfinzi in patients with metastatic TNBC whose tumours express PD-L1. Notes Triple-negative breast cancer TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.5-7 Metastatic TNBC is the most aggressive type of breast cancer and has the worst prognosis, with median overall survival of just 12 to 18 months and only about 14% of patients living five years following diagnosis.5,8,9 While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.5 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.5 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.10,11 However, for the approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the 1st-line standard of care.1,2 TROP2 is a protein broadly expressed in several solid tumours including TNBC.12 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.13,14 TROPION-Breast02 TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as brain metastases. The dual primary endpoints of TROPION-Breast02 are PFS as assessed by blinded independent central review and OS. Key secondary endpoints include PFS as assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety. TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov. Datroway Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Datroway is approved in more than 35 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial. Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Datroway is approved in Russia for the same population. Datroway clinical development programme A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer and five Phase III trials in breast cancer evaluating Datroway as a monotherapy and in combination with other anticancer treatments in various settings. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway 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 previously treated 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, 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.  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 3ImmunotherapyClinical ResultLicense out/inDrug Approval

03 Oct 2025

·www.fiercepharma.com

With FDA approval, Jazz and Roche's combo sets new bar in first-line small cell lung cancer

The National Comprehensive Cancer Network guidelines added Tecentriq-Zepzelca maintenance as a preferred regimen in first-line extensive stage small cell lung cancer a few days before the FDA approval. An FDA approval is setting a new benchmark for future treatment for first-line small cell lung cancer.The FDA has greenlighted Jazz Pharmaceuticals’ Zepzelca, used in combination with Roche’s Tecentriq, as a first-line maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC), the agency said Thursday. The approval also applies to Tecentriq Hybreza, a subcutaneous version of the Roche PD-L1 inhibitor.First-line maintenance treatment is for patients who have not progressed after initial induction therapy. Before Thursday’s approval, Tecentriq in combination with chemotherapy, followed by Tecentriq alone, has been a standard of care in first-line ES-SCLC. The newly FDA-approved regimen now adds Jazz’s Zepzelca, which is also a chemotherapy drug, during the maintenance phase.“For people with extensive-stage small cell lung cancer and their families, the period after induction therapy is often filled with uncertainty, given the high risk of relapse,” Roy Herbst, M.D., Ph.D., from the Yale School of Medicine said in an Oct. 3 statement. The FDA approval of Tecentriq and Zepzelca “may lead to a meaningful shift in how we manage this challenging disease and gives us a new tool to help to delay disease progression and extend survival,” he added.Herbst was a member of the steering committee for the phase 3 IMforte trial that convinced the FDA of Zepzelca and Tecentriq’s treatment effect. Adding Zepzelca reduced the risk of death by 27% more than Tecentriq alone during the maintenance phase. Those who got the combo lived a median 13.2 months, versus 10.6 months among patients in the Tecentriq arm.Patients on the combo also had a 46% lower risk of cancer progression or death. The median progression-free survival time was 5.4 months for the combo versus 2.1 months for Tecentriq alone. When the data were shared at the American Society of Clinical Oncology (ASCO) annual meeting this year, ASCO Chief Medical Officer Julie Gralow, M.D., noted that there’s still room for improvement in first-line ES-SCLC as the regimen’s progression-free survival is still quite short.Nevertheless, the FDA approval, along with a recent addition as a preferred regimen on the National Comprehensive Cancer Network (NCCN) guidelines, is making Tecentriq-plus-chemo, followed by Tecentriq and Zepzelca, as the new efficacy benchmark in first-line ES-SCLC. The NCCN recommendation for the new combo is currently rated at category 2A, which is lower than the original Tecentriq regimen’s category 1.While near-term applications with the FDA do not have to produce a direct head-to-head comparison with the regimen, industry watchers and research doctors will certainly compare any new data in first-line ES-SCLC with the IMforte regimen. This will affect views on Amgen’s DeLLphi-305 trial for adding the DLL3 T-cell engager Imdelltra to AstraZeneca’s Imfinzi also in the first-line maintenance setting. The trial, which kicked off in June 2024, has Imfinzi maintenance alone as the comparator arm.It will also affect future interpretation of results from BioNTech and its partner Bristol Myers Squibb’s relatively new phase 3 Rosetta Lung-01 trial for their PD-L1xVEGF bispecific pumitamig (BNT327) in first-line ES-SCLC.

Phase 3Drug ApprovalClinical ResultASCO

01 Oct 2025

·www.globenewswire.com

ORYZON Strengthens Patent Portfolio for iadademstat with European Grant Decision Covering Combinations with PD1/PD-L1 Inhibitors

MADRID and CAMBRIDGE, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and European leader in epigenetics, today announced that the European Patent Office (EPO) has issued a Decision to Grant for its patent application EP20712594.9, entitled “Combinations of iadademstat for cancer therapy”. The allowed claims protect the use of iadademstat in combination with PD1 or PD-L1 inhibitors for the treatment of cancer, including small cell lung cancer (SCLC). Once formally granted, the patent will remain in force until at least 2040, excluding potential patent term extensions. Corresponding patents have already been allowed or granted in Australia and Russia, with additional applications pending in the United States, Japan, China, and other territories. “We are delighted to have secured this grant, which strengthens protection for iadademstat in combination with immune checkpoint inhibitors such as atezolizumab and durvalumab, a therapeutic approach we are actively pursuing in clinical trials,” said Neus Virgili, Oryzon’s Chief IP Officer. Iadademstat is currently being investigated in combination with PD-L1 inhibitors (atezolizumab or durvalumab) in first line, extensive-disease SCLC patients in a Phase I/II trial conducted and sponsored by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Oryzon. More than 30 sites across the U.S. participate in the trial, including leading institutions such as Memorial Sloan Kettering Cancer Center, Johns Hopkins, City of Hope, Yale University and the University of Chicago, among others. About OryzonFounded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS (Phase III-ready) and iadademstat in oncology (Phase II). The company has other pipeline assets directed against other epigenetic targets like HDAC-6 where a clinical candidate, ORY-4001, has been nominated for its possible development in CMT and ALS. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit www.oryzon.com About IadademstatIadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (see Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). Iadademstat has shown encouraging safety and strong clinical activity in combination with azacitidine in a Phase IIa trial in elder 1L AML patients (ALICE trial) (see Salamero et al., ASH 2022 oral presentation & The Lancet Haematology, 2024, 11(7):e487-e498). Iadademstat is currently being evaluated in combination with gilteritinib in the ongoing Phase Ib FRIDA trial in patients with relapsed/refractory AML with FLT3 mutations, and in combination with azacitidine and venetoclax in 1L AML in an investigator-initiated study led by OHSU and in a trial sponsored by the U.S. National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) signed between Oryzon and the NCI to collaborate on further clinical development of iadademstat in different types of hematologic and solid cancers. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors (NET), medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). Iadademstat is in a Phase I/II randomized trial in 1L ED-SCLC in combination with ICI sponsored by NCI and led by the Memorial Sloan Kettering Cancer Center. Oryzon is further expanding the clinical development of iadademstat in oncology through additional CRADA and investigator-initiated studies. In addition, Oryzon is expanding iadademstat’s clinical development into non-oncological hematology indications, with trials in sickle cell disease (CTA approved) and essential thrombocythemia (trial in preparation). Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU. FORWARD-LOOKING STATEMENTSThis communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events, or otherwise. This document does not constitute an offer or invitation to purchase or subscribe shares in accordance with the provisions of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, and/or the restated text of the Securities Market Law, approved by Law 6/2023 of 17 March, and its implementing regulations. Nothing in this document constitutes investment advice. In addition, this document does not constitute an offer of purchase, sale or exchange, nor a request for an offer of purchase, sale or exchange of securities, nor a request for any vote or approval in any jurisdiction. The shares of Oryzon Genomics, S.A. may not be offered or sold in the United States of America except pursuant to an effective registration statement under the Securities Act of 1933 or pursuant to a valid exemption from registration.. SpainOryzonIR & Media, Europe & USPatricia Cobo/Mario CorderaEmili TorrellSandya von der WeidAtreviaChief BD OfficerLifeSci Advisors, LLC+34 91 564 07 25 +34 673 33 97 65+34 93 515 1313+41 78 680 05 38pcobo@atrevia.com mcordera@atrevia.cometorrell@oryzon.comsvonderweid@lifesciadvisors.com

Phase 2Orphan DrugPhase 1Clinical Result

100 Deals associated with Durvalumab

External Link

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
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
Advanced Hepatocellular Carcinoma	Liechtenstein	AstraZeneca AB	14 Apr 2023
Advanced Hepatocellular Carcinoma	Norway	AstraZeneca AB	14 Apr 2023
Metastatic Biliary Tract Carcinoma	European Union	AstraZeneca AB	14 Apr 2023
Metastatic Biliary Tract Carcinoma	Iceland	AstraZeneca AB	14 Apr 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastrooesophageal junction cancer	NDA/BLA	United States	AstraZeneca PLC	28 Jul 2025
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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03518606 (MOVIE, Pubmed \| Breast)	Phase 2	Advanced breast cancer ER Negative \| PR Negative \| HER2 Negative	30	Tremelimumab plus Durvalumab combined to metronomic oral Vinorelbine	pytqpytivl(jlhguwltak) = wuelcohdqs tpiiwkyjbk (ynvzcyzpbq, 5.5 - 29.8) View more	Negative	01 Oct 2025
NCT03019003 (CTgov)	Phase 1	Squamous cell carcinoma of head and neck metastatic \| Head and Neck Neoplasms	13	Oral decitabine+Durvalumab	lrebhtlchv = rgyppsvswz jjjqjccgoj (ypqwjlqjxp, hioolpnufl - smilkehhqa) View more	-	16 Sep 2025
NCT03800134 (AEGEAN, WCLC2025)	Phase 3	Non-Small Cell Lung Cancer Neoadjuvant PD-L1 status	740	Neoadjuvant chemotherapy plus durvalumab	thjatejxjw(bfjngrzuxs) = isiexvvcmv gharbhgirw (ktjwoiojvs ) View more	Positive	09 Sep 2025
NCT03800134 (AEGEAN, WCLC2025)	Phase 3	Non-Small Cell Lung Cancer Neoadjuvant PD-L1 status	740	Neoadjuvant chemotherapy plus placebo	thjatejxjw(bfjngrzuxs) = bthdcyesfw gharbhgirw (ktjwoiojvs ) View more	Positive	09 Sep 2025
NCT03638141 (CTgov)	Phase 2	Hepatocellular Carcinoma	21	Tremelimumab+Durvalumab	fmwmdfiwac = tjglgtnzry lsbrryolrm (kqaqsbdnfc, idaunemcat - ygxozlhzij) View more	-	17 Aug 2025
NCT04336943 (CTgov)	Phase 2	Non-metastatic prostate cancer \| Adenocarcinoma of prostate	6	Quality-of-Life Assessment+Olaparib+Durvalumab	irvqprnwzb(uejthmahuy) = oqftbjokfw vfhsqmwazs (jznakedvne, jephmhrcsr - uwkrpghojh) View more	-	11 Aug 2025
NCT05061550 (NeoCOAST-2, Pubmed \| Nat Med) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma First line \| Adjuvant \| Neoadjuvant	199	Durvalumab + Platinum-doublet chemotherapy + Oleclumab	ikdrjavsou(czcoqfydsr) = xeujlrhiaf gwciyjwlpv (hqgqslyxyj, 11.8 - 31.2) View more	Positive	01 Aug 2025
NCT05061550 (NeoCOAST-2, Pubmed \| Nat Med) Manual	Phase 2		199	Durvalumab + Platinum-doublet chemotherapy + Monalizumab	ikdrjavsou(czcoqfydsr) = ksarbwdhec gwciyjwlpv (hqgqslyxyj, 16.0 - 37.6) View more	Positive	01 Aug 2025
NCT03703297 (ADRIATIC, CTgov)	Phase 3	Small cell lung cancer limited stage	730	Durvalumab (Durvalumab)	exyhzbwxse(cqmicxedfq) = hbpwyebuyv gklanxhcoj (lrknjtrkbx, mqtpfwrxqz - piwjssbenn) View more	-	01 Aug 2025
NCT03703297 (ADRIATIC, CTgov)	Phase 3	Small cell lung cancer limited stage	730	placebo (Placebo)	exyhzbwxse(cqmicxedfq) = vhvtxdtbyc gklanxhcoj (lrknjtrkbx, yljxhhdiig - nhhuasbcqb) View more	-	01 Aug 2025
NCT05927142 (DURIPANC, GlobeNewswire) Manual	Phase 2	Metastatic Pancreatic Cancer	14	rintatolimod + durvalumab	jpjslantsj(xhcgqmfvbq) = nbweeichmf ryphvtjivg (jngutrcyck ) View more	Positive	28 Jul 2025
NCT04026412 (CheckMate 73L \| CheckMate73L \| CheckMate -73L, CTgov)	Phase 3	Locally Advanced Lung Non-Small Cell Carcinoma	925	Nivolumab+Ipilimumab (Arm A:Nivo + CCRT/Nivo + Ipi)	emkaecayzb(grxcghhvvt) = mczrizpjqp zruprdacoe (lqacgfltcx, zxyhokkgcu - iuflpaqnls) View more	-	24 Jul 2025
	Phase 3	Locally Advanced Lung Non-Small Cell Carcinoma	925	Durvalumab (Arm C: CCRT/Durva)	emkaecayzb(grxcghhvvt) = alebgaeiuf zruprdacoe (lqacgfltcx, rcdqazwdyk - bqilesqzfu) View more	-	24 Jul 2025
NCT03529422 (NCT02000947, CTgov)	Phase 2	Lymphoid Interstitial Pneumonia \| Squamous Cell Carcinoma of Head and Neck \| Digestive System Disorders ... View more	18	Intensity Modulated Radiotherapy Treatments+Durvalumab	sycbpfflcl = wmbwgcixxt qoblcrkvtb (gagjrwwyhm, cqfcekmiwp - jxoswyzpka) View more	-	20 Jul 2025

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