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Last update 05 Nov 2026

Durvalumab

Last update 05 Nov 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+ [12]

Active Indication

Non-Muscle Invasive Bladder NeoplasmsStomach CancerEarly gastric cancer+ [192]

Inactive Indication

Acute Myeloid LeukemiaAdenocarcinoma of LungAdenocarcinoma of prostate+ [103]

Originator Organization

AstraZeneca UK Ltd.

Active Organization

AstraZeneca PLCAstraZeneca AB

Daiichi Sankyo Co., Ltd.

+ [19]

Inactive Organization

MedPacto, Inc.

Juno Therapeutics, Inc.

Fred Hutchinson Cancer Research Center

+ [7]

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: *****

942

Clinical Trials associated with Durvalumab

NCT07639528

/ Not yet recruitingPhase 2IIT

Phase II, Open Label, Non-Randomized, Study of Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC)

This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and/or targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.

Start Date10 Dec 2027

Sponsor / Collaborator

Northwestern University

[+1]

NCT07168668

/ Not yet recruitingPhase 2IIT

EXploring Clinical Efficacy of Partial Immune-boost TACE in unrEseCTable HCC Patients Under Systemic Treatment (EXPECT Trial)

Study Objectives： Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) combined with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) or Durvalumab (anti-programmed death-ligand 1; anti-PD-L1) combined with tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4; anti-CTLA4) have recently been established as a standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). However, its objective response rate (ORR) is only less than 27% (1, 2), and the majority of patients died of HCC progression and liver failure. Therefore, there is an urgent need to develop a novel combination treatment strategy to overcome resistance to immunotherapy and improve patient outcomes.
Transarterial chemoembolization (TACE) remains the standard treatment for patients with intermediate-stage hepatocellular carcinoma (HCC) (3, 4). However, in our previous retrospective study (5-7), the investigators consistently observed that this combination not only improves therapeutic responses but also significantly prolongs patient survival. The tumor necrosis caused by TACE may enhance the efficacy of systemic therapies by promoting the release of neoantigens, thereby stimulating immune responses (8-14). This concept has been substantiated in two recent trials involving intermediate-stage HCC (15, 16), where the addition of immune checkpoint inhibitors to TACE resulted in improved clinical outcomes. Nevertheless, this promising approach has yet to replace the decades-old standard treatment protocols, underscoring the need for further proof-of-concept studies.
Both immunotherapy (atezolizumab/bevacizumab or durvalumab/tremelimumab) and transarterial chemoembolization (TACE) are approved treatment modalities for unresectable hepatocellular carcinoma (HCC) by the U.S. and Taiwan Food and Drug Administration (FDA). This phase II non-randomized trial is designed to prospectively evaluate the therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with a combination of immunotherapy and TACE. A particular focus of this study is to explore the potential immune-boosting effects of TACE, including its ability to enhance antigen presentation and stimulate anti-tumor immune responses.

Start Date01 Feb 2027

Sponsor / Collaborator

Chang Gung Memorial Hospital

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 Jan 2027

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

100 Clinical Results associated with Durvalumab

100 Translational Medicine associated with Durvalumab

100 Patents (Medical) associated with Durvalumab

2,680

Literatures (Medical) associated with Durvalumab

31 Dec 2026·ANNALS OF MEDICINE

Dose-Registered CT assessment of radiation-induced lung injury after chemoradiotherapy for stage III NSCLC

Article

Author: Sugahara, Shinji ; Ikeda, Norihiko ; Okubo, Mitsuru ; Itonaga, Tomohiro ; Zama, Tatsuhiko ; Mikami, Ryuji ; Saito, Kazuhiro

AIMS:

To quantify radiation-induced lung injury (RILI) on deformably registered CT images after chemoradiotherapy (CCRT) for stage III NSCLC, and to evaluate spatial and dosimetric associations between RILI and planned dose distribution in a pre-durvalumab cohort.

METHODS:

This retrospective study included 58 patients with stage III NSCLC treated with CCRT using three-dimensional conformal radiotherapy (3D-CRT) prior to the era of consolidation immunotherapy. Follow-up CT images at 6 months (acute) and 12 months (late) were registered to treatment planning CT using deformable image registration (DIR). RILI was quantified by segmented volume (mL) and isodose-line overlap (%). Dosimetric parameters (V5Gy-V60Gy, mean lung dose) and symptomatic RILI (CTCAE grade ≥2) were analysed using correlation, ROC, and logistic regression methods.

RESULTS:

Symptomatic RILI occurred in 14 patients (24.1%). RILI volume decreased by 27.7% from the acute to the late phase, with moderate-to-strong dose-volume correlations in both phases (Spearman ρ = 0.69-0.76). Symptomatic patients showed broader spatial spread into lower-dose regions (median isodose-line overlap 20% vs 40%; p < 0.001). Acute-phase RILI reaching the ≤25% isodose line (≤16.5 Gy) was an exploratory imaging marker in this cohort (AUC 0.81) that remained associated with symptomatic RILI on multivariable analysis (p < 0.01).

CONCLUSIONS:

Dose-registered CT analysis demonstrated consistent spatial associations between planned dose and RILI, providing a hypothesis-generating dosimetric-radiographic reference dataset that requires external validation in IMRT/VMAT- and durvalumab-treated cohorts before clinical application.

31 Dec 2026·OncoImmunology

Pooled analysis of 2 clinical trials of first-line chemoimmunotherapy for metastatic microsatellite stable colorectal cancer MEDITREME and METIMMOX studies

Article

Author: Ilie, Alis ; Truntzer, Caroline ; Flatmark, Kjersti ; Peroz, Morgane ; Derangère, Valentin ; Bousquet, Paula Anna ; Rageot, David ; Ree, Anne Hansen ; Thibaudin, Marion ; Meltzer, Sebastian ; Ghiringhelli, François

BACKGROUND:

Colorectal cancer with microsatellite stable (MSS) status is intrinsically resistant to immune checkpoint inhibitor monotherapy targeting PD-1 or PD-L1. However, emerging evidence suggests that chemotherapies may overcome this resistance when combined with immunotherapy.

METHODS:

We conducted a pooled analysis of individual patient data from two phase II trials evaluating oxaliplatin-based chemotherapy combined with checkpoint inhibitors as first-line treatment for MSS metastatic colorectal cancer. The MEDITREME trial is a single-arm study assessing durvalumab and tremelimumab with oxaliplatin-based chemotherapy, while the METIMMOX trial is a randomized study comparing standard oxaliplatin-based chemotherapy with an alternating regimen of oxaliplatin-based chemotherapy and nivolumab. We compared overall survival (OS), progression-free survival (PFS), and response rates between patients treated with chemotherapy alone versus chemoimmunotherapy, and evaluated the association between these outcomes and transcriptomic and immunoscore data.

RESULTS:

A total of 130 patients were included: 38 who received chemotherapy alone and 92 chemoimmunotherapy. The median OS was significantly improved in the chemoimmunotherapy group compared with chemotherapy alone (not reached vs. 15.3 months; HR = 0.58; 95% CI, 0.36-0.96; p = 0.03). The complete response rates were higher with chemoimmunotherapy (14% vs. 5%). No significant differences were observed in PFS. High baseline CD8⁺ T-cell infiltration was associated with improved outcomes in patients receiving chemoimmunotherapy but not in those treated with chemotherapy alone.

CONCLUSIONS:

This pooled analysis provides compelling evidence supporting the clinical benefit of first-line chemoimmunotherapy in a subset of patients with MSS mCRC. Baseline CD8⁺ T-cell infiltration may serve as a predictive biomarker for identifying patients most likely to benefit from this treatment approach.

31 Dec 2026·OncoImmunology

Circadian timing of first-line chemoimmunotherapy is associated with survival in extensive-stage small cell lung cancer

Article

Author: Fidan, Sena ; Engin Delipoyraz, Ebru ; Terzioglu, Cihat ; Cakir, Tansel ; Cakan Demirel, Burcin ; Muglu, Harun ; Kutlu, Yasin ; Hamdard, Jamshid ; Ozcelik, Hakan ; Seker, Mesut ; Sunger, Erdem ; Yucel, Mehmet Haluk ; Bilici, Ahmet ; Acıkgoz, Ozgur ; Mildanoglu, Maral Martin

Growing evidence suggests that circadian timing influences the efficacy of immune checkpoint inhibitors across multiple malignancies. However, evidence in extensive-stage small cell lung cancer (ES-SCLC) remains limited to a single East Asian cohort, and independent validation in other populations is lacking. We conducted a retrospective single-center cohort study of 107 patients with ES-SCLC treated with first-line platinum-etoposide plus atezolizumab or durvalumab. The time of day of administration (ToDA) was defined as the median start time of the first four immunotherapy infusions, and patients were categorized according to the cohort median ToDA. The primary endpoints were progression-free survival (PFS) and overall survival (OS). The cohort median ToDA was 11:54. Patients treated before the median ToDA had significantly longer median PFS (9.07 vs. 7.23 months, p = 0.002) and OS (21.17 vs. 11.43 months, p = 0.002) than those treated later. In multivariable Cox regression analysis, later administration remained independently associated with shorter PFS (adjusted HR 1.63, 95% CI 1.03-2.58; p = 0.038) and OS (adjusted HR 1.65, 95% CI 1.00-2.71; p = 0.049), whereas objective response rates, treatment-related toxicity, and immune-related adverse events were comparable between groups. Morning administration of first-line chemoimmunotherapy was associated with significantly longer survival without increased toxicity in patients with ES-SCLC. These findings support growing evidence that circadian timing may influence immune checkpoint inhibitor efficacy and warrant prospective evaluation of treatment timing as a readily modifiable strategy to optimize immunotherapy delivery.

1,393

News (Medical) associated with Durvalumab

05 Nov 2026

·www.biospace.com

AIM ImmunoTech Highlights Ampligen® Opportunity to Potentially Extend Benefits of RAS-Targeted Therapies in Pancreatic Cancer

New investor presentation outlines scientific rationale for combining Ampligen’s immune-stimulating activity with daraxonrasib’s targeted RAS inhibition to potentially prolong clinical benefit Previously reported Ampligen clinical observations support further investigation in pancreatic cancer Phase 2 DURIPANC topline results expected in Q1 2027, with additional clinical and immune-response analyses anticipated in Q3 2027 Access the presentation here OCALA, Fla., Nov. 05, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the release of a new investor presentation, “ The Ampligen Opportunity ,” highlighting the potential for Ampligen (rintatolimod) to complement emerging RAS-targeted therapies in pancreatic cancer, including Revolution Medicines’ Rasonque™ (daraxonrasib). The presentation examines recent advances in pancreatic cancer treatment and the scientific rationale for combining RAS inhibition with immune stimulation to potentially enhance and extend clinical benefit. It also highlights previously reported Ampligen clinical observations, the ongoing Phase 2 DURIPANC program and anticipated 2027 milestones. AIM Chief Executive Officer Thomas K. Equels states: “Ampligen has been demonstrated to be a powerful innate immunomodulator with broad-spectrum anti-tumor proliferation effects, while the RAS-targeted therapy daraxonrasib represents a new and promising development which, I believe, will likely become a first-line therapy for pancreatic cancer. I see great potential in bringing the two together. While daraxonrasib targets the signaling pathways that drive tumor growth, Ampligen is designed to stimulate innate and adaptive immune responses, which helps set Ampligen apart among late-stage clinical trials for pancreatic cancer. We believe these potentially complementary mechanisms of action provide a compelling foundation for investigating how Ampligen might enhance and prolong the benefits of targeted RAS treatment, which is especially significant because of daraxonrasib’s potential to become the standard of care therapy for pancreatic cancer in the very near future.” Key Highlights from the Investor Presentation Daraxonrasib’s Phase 3 Results and the Potential for Complementary Treatment Strategies The presentation highlights results from the randomized Phase 3 RASolute 302 study evaluating daraxonrasib against investigators’ choice of chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma. In the overall study population, daraxonrasib demonstrated: Median overall survival of 13.2 months versus 6.7 months with chemotherapy (hazard ratio: 0.40). Median progression-free survival of 7.2 months versus 3.6 months with chemotherapy (hazard ratio: 0.49). These findings underscore the progress being made in RAS-targeted treatment and the opportunity to investigate strategies that may further extend disease control. Complementary Mechanisms Support Further Investigation Daraxonrasib inhibits RAS(ON) signaling involved in tumor growth, while Ampligen is an investigational Toll-like receptor 3 (TLR3) agonist designed to stimulate innate and adaptive immune responses. Previously published research involving Ampligen has demonstrated immune modulation involving dendritic cells and T-cell responses. AIM believes these distinct mechanisms support further investigation of whether Ampligen could enhance anti-tumor immune activity alongside RAS inhibition. The proposed combination remains investigational, and its safety, efficacy and potential to improve outcomes beyond daraxonrasib alone have not been established. Previously Reported Ampligen Clinical Observations Provide an Encouraging Foundation The presentation highlights findings from a Netherlands government-approved Named Patient Program evaluating Ampligen following FOLFIRINOX chemotherapy in patients with advanced pancreatic cancer. In this nonrandomized program, 57 Ampligen-treated patients were compared with 27 historical controls. Exploratory findings included: Median overall survival of 19.7 months versus 12.5 months in historical controls. Median progression-free survival of 12.6 months versus 8.6 months in historical controls. Median overall survival of 34.8 months in an Ampligen-treated subgroup with a baseline neutrophil-to-lymphocyte ratio of 4.5 or less, versus 19.3 months among Ampligen-treated patients with higher ratios. DURIPANC Program Advancing Toward Key 2027 Clinical Milestones AIM’s ongoing Phase 1/2 DURIPANC study is evaluating Ampligen in combination with durvalumab (Imfinzi ® ) in patients with metastatic pancreatic cancer who achieved stable disease following FOLFIRINOX chemotherapy. The study enrolled 28 patients across Phase 1 and Phase 2. The Phase 2 primary endpoint is clinical benefit rate at 24 weeks. To date, the clinical trial has met each milestone on schedule. Previously reported interim findings include encouraging tolerability, with only three Grade 3 immune-related adverse events; consistently high patient-reported quality of life; and preliminary evidence of coordinated innate and adaptive immune activation. AIM anticipates the following milestones: Q1 2027: Phase 2 topline results evaluating clinical benefit rate at 24 weeks. Q3 2027: Additional analyses of overall survival, progression-free survival, quality of life and immune responses. These findings are expected to help inform future development opportunities, including the potential design of a pivotal Phase 3 trial. Exploring the Potential to Extend RAS-Targeted Treatment Benefits The presentation also outlines a proposed development strategy to investigate whether adding Ampligen to ongoing daraxonrasib treatment, or as a post-daraxonrasib maintenance therapy, could strengthen anti-tumor immune responses and potentially extend disease control. Potential evaluations include safety, biological activity, treatment timing, progression-free survival and duration of response. This proposed strategy is not an established clinical trial protocol, and additional research would be required to evaluate the combination. Positioning Ampligen for the Evolving Pancreatic Cancer Treatment Landscape As RAS-targeted therapies continue to advance, AIM believes Ampligen’s immunomodulatory mechanism and existing clinical observations provide a foundation for exploring complementary treatment strategies. With anticipated DURIPANC milestones in 2027, the Company remains focused on generating additional clinical evidence while evaluating opportunities to expand Ampligen’s potential role in pancreatic cancer treatment. The Company’s new investor presentation, “ The Ampligen Opportunity ,” is available here . About Ampligen ® Ampligen ® (rintatolimod) is an investigational immunomodulatory drug that acts through Toll-like receptor 3 (TLR3) signaling. It is being investigated for its potential to stimulate innate and adaptive immune responses across multiple disease settings, including cancer. In pancreatic cancer, research has demonstrated immune modulation involving dendritic-cell-mediated T-cell responses. Ampligen is not approved by the U.S. Food and Drug Administration for the treatment of pancreatic cancer. 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. For more information, please visit aimimmuno.com and connect with the Company on X , LinkedIn , and Facebook . Trademark Note Rasonque™ is a registered trademark of Revolution Medicines Inc. AIM ImmunoTech is not affiliated with, sponsored by, or endorsed by Revolution Medicines Inc. Cautionary Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve a number of risks and uncertainties. Any forward-looking statements set forth in this press release speak only as of the date hereof. Such forward-looking statements may include statements relating to: the potential of Ampligen to enhance and extend clinical benefit; the potential of combined treatment approaches to pancreatic cancer; the potential for any such effect to be durable or long-lasting; Ampligen’s potential to complement existing therapies and to overcome biological barriers that have limited treatment success in pancreatic cancer; the timing, conduct and outcome of the DURIPANC primary endpoint analyses, biomarker evaluations and overall survival follow-up; the timing and outcome of planned regulatory interactions; the Company’s long-term pancreatic cancer development strategy and its efforts to position Ampligen for the next stage of development; and the Company’s ability to create long-term value for its stockholders. Forward-looking statements include statements attributed to, or made by, the Company’s Chief Executive Officer in this press release. For all forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical fact, including statements regarding the potential of Ampligen’s mechanism of action, anticipated regulatory milestones, our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. Words such as “believe,” “may,” “might,” “will,” “could,” “should,” “can,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “envision,” “potential” and similar expressions are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof, except as required by applicable law. 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 preclinical studies 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, lack of adequate funding, 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. No assurance can be given that the findings in preliminary studies will prove true or that such studies will yield favorable results, or 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. 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. For a detailed discussion of these and other risk factors, please review the “Risk Factors” section in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the U.S. Securities and Exchange Commission. These filings are available at and You should not place undue reliance on any forward-looking statements. The information found on the Company’s website or on other websites referenced or linked to in this press release is not incorporated by reference into this press release and such information is referenced or linked for reference purposes only. CONTACT: Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com

Phase 2ImmunotherapyClinical ResultPhase 3

05 Nov 2026

·www.biospace.com

Ivonescimab Receives NMPA Priority Review for First-Line Biliary Tract Cancer

HONG KONG , Nov. 4, 2026 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926.HK) today announced that ivonescimab in combination with chemotherapy for the first-line treatment of locally advanced or metastatic biliary tract cancer (BTC) has been granted Priority Review by China's National Medical Products Administration (NMPA). The Priority Review designation is expected to accelerate the subsequent regulatory review process for this indication in China. In the randomized, double-blind, multicenter Phase III registrational study HARMONi-GI1 (AK112-309), ivonescimab plus chemotherapy demonstrated superior survival benefit for patients versus durvalumab plus chemotherapy, the current global standard for the first-line treatment of BTC. In a prespecified interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), HARMONi-GI1 met its primary endpoint of overall survival (OS), with the ivonescimab plus chemotherapy arm demonstrating statistically significant and clinically meaningful improvement over the control arm. The trial also met all key secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR). The HARMONi-GI1 results were presented as a Late-Breaking Abstract in an oral presentation at the ESMO Presidential Symposium in October 2026. HARMONi-GI1 is the first Phase III trial in BTC to show statistically significant overall survival benefit against the established PD-L1 inhibitor plus chemotherapy standard of care. On October 21, 2026, Summit announced a clinical trial collaboration with ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) to evaluate the safety and efficacy of ivonescimab with chemotherapy compared to pembrolizumab or durvalumab plus chemotherapy in a registration-enabling Phase II/III study (EA2251), in the first-line treatment of patients with advanced BTC. About Ivonescimab Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody independently developed by Akeso. It is the world's first approved bispecific antibody that combines immuno-oncology and anti-angiogenesis mechanisms in a single molecule, helping to define a new generation of bispecific immuno-oncology therapies. Ivonescimab is also the first therapy to demonstrate positive results in a Phase III head-to-head study against pembrolizumab. Building on its strong clinical pro the IO2.0 landscape, Akeso is advancing a comprehensive global development program for ivonescimab across multiple tumor types and treatment settings. As a cornerstone of the Company's IO2.0 + ADC2.0 strategy, ivonescimab aims to help reshape standards of care in major cancers worldwide. More than 17 Phase III studies of ivonescimab are underway globally, including seven international multi-regional registrational Phase III trials and seven head-to-head studies versus PD-1/PD-L1 therapies. These programs encompass eight registrational or Phase III studies in lung cancer, as well as trials in first-line MSS/pMMR colorectal cancer, first-line PD-L1-positive head and neck squamous cell carcinoma (in combination with ligufalimab versus pembrolizumab), first-line biliary tract cancer (versus pembrolizumab/ durvalumab-based regimen), first-line triple-negative breast cancer, first-line pancreatic cancer, and first-line urothelial carcinoma (versus pembrolizumab plus a Nectin-4 ADC). Akeso has out-licensed the exclusive rights to develop and commercialize ivonescimab in the United States and Canada, South America, Europe, the Middle East, Africa, and Japan to Summit Therapeutics under an agreement with a total potential value of up to US$5 billion. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, Akeso has built a comprehensive R&D innovation ecosystem anchored by its proprietary Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the Company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, nearly 30 candidates have advanced into clinical trials, including 15 bispecific or multi-specific antibodies and bispecific ADCs. Eight innovative drugs are commercially available, and two additional drugs with three indications are currently under regulatory review for marketing approval. Akeso is committed to becoming a global leader in biopharmaceuticals through efficient and breakthrough innovation in R&D, developing novel therapies that are first-in-class or best-in-class, and providing better disease solutions for patients around the world. Forward-Looking Statements This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the P.R. China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. View original content: SOURCE Akeso, Inc.

Phase 3Priority ReviewLicense out/inClinical ResultDrug Approval

05 Nov 2026

·www.biospace.com

Summit Therapeutics Reports Financial Results and Operational Progress for the Third Quarter and Nine Months Ended September 30, 2026

Recent $2 Billion Strategic Equity Investment in Summit by AstraZeneca and Summit’s Expanding Network of Clinical Collaborations Underscore Confidence in Ivonescimab’s Potential Ivonescimab Global Clinical Development Program Continues to Grow with New Studies in Bladder and Kidney Cancers Ivonescimab Regimens Demonstrate Statistically Significant Overall Survival Benefits Versus Pembrolizumab in PD-L1–Positive Advanced NSCLC and Versus Durvalumab Plus Chemotherapy in Biliary Tract Cancer in Akeso’s Phase III Studies Conducted in China Summit Closes Third Quarter with $629.8 Million in Cash and Investments and Received $2.0 Billion from AstraZeneca in Connection with an Equity Investment Post Third Quarter MIAMI--(BUSINESS WIRE)-- $SMMT --Summit Therapeutics Inc. (NASDAQ: SMMT) today reported its financial results for the third quarter and nine months ended September 30, 2026, and provided an update on clinical and operational progress. “This quarter marked a period of meaningful momentum for Summit, highlighted by AstraZeneca’s $2 billion strategic equity investment and the expansion of our network of clinical collaborations with AstraZeneca, Daiichi Sankyo, and several others,” said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. “These commitments underscore ever growing confidence in ivonescimab’s potential across a broad range of solid tumors.” “Our global clinical development program for ivonescimab continues to broaden, with the announcement of ivonescimab combination collaborations with Datroway® and sone-ve, alongside new studies in bladder cancer with HARMONi-GU1, in biliary tract cancer with EA2251, and in kidney cancer with SMT112-216 and Arcus’ ARC-20 platform study,” said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. “We are encouraged by the statistically significant overall survival results recently presented from Akeso’s HARMONi-2 study in PD-L1–positive advanced NSCLC and HARMONi-GI1 study in BTC, and we look forward to the upcoming initial HARMONi-3 data in first-line squamous NSCLC.” Clinical & Operational Updates Clinical and operational progress continues with ivonescimab, a novel, potentially first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule: Summit in-licensed ivonescimab from Akeso Inc. in January 2023. In total, over 5,000 patients have been treated with ivonescimab in clinical studies globally, and over 100,000 patients have been treated in the commercial setting with ivonescimab in China, as noted and updated by Akeso. Summit has exclusive rights to develop and commercialize ivonescimab in North America, South America, Europe, the Middle East, Africa, and Japan, while Akeso retains development and commercialization rights for remaining territories, including China. Summit is currently developing ivonescimab in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), urothelial carcinoma (UC), and renal cell carcinoma (RCC), specifically conducting multiregional Phase II or Phase III clinical trials in the following proposed indications or settings: HARMONi (Phase III): ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI); HARMONi-3 (Phase III): ivonescimab combined with chemotherapy in patients with first-line metastatic NSCLC, with two distinct cohorts to be analyzed separately for squamous tumors and non-squamous tumors; HARMONi-7 (Phase III): ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression; HARMONi-GI3 (Phase III): ivonescimab combined with chemotherapy in patients with first-line unresectable metastatic CRC; HARMONi-GU1 (Phase II / III): ivonescimab plus the antibody-drug conjugate (ADC) enfortumab vedotin (EV) in previously untreated patients with first-line metastatic UC; and SMT112-216 (Phase II): multiple ivonescimab-based combination treatment regimens in first line patients with metastatic clear cell RCC (ccRCC) (SMT112-216 is also referred to as AK112-216 in China). HARMONi In January 2026, the U.S. Food and Drug Administration (FDA) accepted for filing Summit's Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have received prior EGFR TKI therapy. The BLA was submitted based on the results of the global Phase III HARMONi trial. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. The HARMONi study has dual primary endpoints: progression-free survival (PFS) and overall survival (OS). HARMONi met its PFS primary endpoint, becoming the first global Phase III study of an immunotherapy-based regimen to show a statistically significant PFS improvement in this setting. In the primary analysis for OS, ivonescimab in combination with chemotherapy showed a positive trend without achieving a statistically significant result. As previously disclosed, the FDA noted that a statistically significant OS benefit is necessary to support marketing authorization in this setting. Considering the safety and efficacy pro the current FDA-approved options for patients in this setting – none of which have demonstrated a statistically significant OS benefit – as well as the continued positive, regionally consistent data of this Phase III multiregional study, and discussions with key opinion leaders and physicians who have administered ivonescimab to patients, Summit believes that ivonescimab is a potential treatment option with a favorable benefit-risk profile. In September 2026, updated OS results from HARMONi were presented at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026). With longer follow-up, western patients replicated the survival improvement seen in Asian patients, further reinforcing the regional consistency of the efficacy results observed in the HARMONi study. The updated June 2026 analysis continued to show consistent, favorable OS results, with an OS hazard ratio of 0.76 (95% CI: 0.61 – 0.95; nominal p=0.0151) in the global intention-to-treat (ITT) population. An OS hazard ratio of 0.76 was demonstrated in the western patient subgroup (95% CI: 0.52 – 1.10), which was consistent with the ITT population and Asian subgroup. In this most recent analysis, ivonescimab continued to demonstrate an acceptable and manageable safety pro was consistent with previous Phase III data of ivonescimab plus chemotherapy. No additional safety signals were noted in this latest HARMONi data cut. These results have been made available to the FDA. HARMONi-3 Enrollment in both the squamous and non-squamous NSCLC cohorts of the global HARMONi-3 study is complete. The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the fourth quarter of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis. An interim analysis for OS independent of PFS is planned for the first half of 2027. For the non-squamous cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027. HARMONi-7 Summit's global Phase III HARMONi-7 trial continues to enroll, with enrollment expected to be completed in 2027. In September 2026, interim OS data for HARMONi-2, an Akeso-sponsored Phase III study evaluating ivonescimab monotherapy in a similar setting to Summit’s HARMONi-7 trial, was presented WCLC 2026. In this protocol-specified interim analysis of OS, a secondary endpoint in the HARMONi-2 study, ivonescimab monotherapy demonstrated a statistically significant and clinically meaningful improvement compared to pembrolizumab monotherapy, achieving a hazard ratio (HR) of 0.73 (95% CI: 0.57, 0.95; p=0.009). A clinically meaningful benefit was demonstrated across important clinical subgroups, including those with PD-L1 low expression (PD-L1 Score 1-49%) and PD-L1 high expression (PD-L1 Score ≥ 50%), along with those with squamous and non-squamous histologies. In this analysis, ivonescimab continued to demonstrate an acceptable and manageable safety profile, which was consistent with previous Phase III studies of ivonescimab and no additional safety signals were noted. HARMONi-2 evaluated monotherapy ivonescimab compared to monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-2 is a single region, multi-center, double-blinded Phase III study conducted in China sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. HARMONi-GI3 Summit is continuing to enroll the HARMONi-GI3 study, which is expected to include 900 patients. The enrollment rate has exceeded initial estimations and is currently expected to complete in Q3 2027. HARMONi-GU1 In August 2026, the company announced the planned initiation of the global, multi-regional Phase II / III HARMONi-GU1 trial expanding ivonescimab’s global registration-enabling clinical development program to now include UC, or bladder cancer. Global clinical trial site activations for and enrollment in HARMONi-GU1 have begun for the Phase II portion of this study. SMT112-216 In October 2026, Summit announced the initiation and opening of trial sites for SMT112-216, a randomized, open-label, global Phase II study of ivonescimab in previously untreated advanced ccRCC, the most common type of kidney cancer. The study, also referred to as AK112-216, is being conducted in collaboration with Summit’s partner, Akeso. Participants will be randomized to receive ivonescimab in combination with cadonilimab, ivonescimab in combination with ipilimumab, ivonescimab monotherapy, or nivolumab plus ipilimumab as an established standard-of-care comparator regimen. Cadonilimab is an investigational PD-1 x CTLA-4 bispecific antibody developed by Akeso. This study, in addition to collaborative work being performed by Arcus combining ivonescimab with the HIF2α inhibitor, casdatifan, will be used to inform registration-enabling studies in first-line ccRCC with ivonescimab. SMT112-216 has begun enrollment and plans to enroll approximately 100 patients at clinical trial sites in the U.S. and China. Additional Ivonescimab Development Updates In September 2026, Summit entered into a clinical trial collaboration with AstraZeneca to evaluate ivonescimab in combination with AstraZeneca’s Claudin 18.2-targeting ADC, sonesitatug vedotin, also referred to as sone-ve, in certain gastrointestinal cancer settings. Each company will contribute their respective compound for the combination studies to be conducted, and the parties will jointly contribute to the costs of such studies, which are intended to be sponsored by AstraZeneca. The collaboration does not include upfront payments, milestone payments, or royalty sharing provisions. Each company will retain development and commercial rights to their respective molecules. Additionally in September 2026, the company executed a non-binding Memorandum of Understanding with AstraZeneca whereby the two companies intend to enter into an agreement to conduct clinical trials combining ivonescimab with multiple AstraZeneca cancer medicines, including AstraZeneca’s leading portfolio of antibody-drug conjugates (ADCs). The companies intend to share clinical development costs of potential future studies. Each company will retain their current development and commercial rights to their respective molecules, and the agreement is mutually non-exclusive. The memorandum of understanding does not include upfront payments, milestone payments, or royalty sharing provisions. In October 2026, Summit announced a clinical trial collaboration with AstraZeneca and Daiichi Sankyo to evaluate ivonescimab in combination with the TROP2-directed ADC datopotamab deruxtecan (Datroway®) across multiple solid tumor settings, intending to include breast and lung cancer. The companies intend to begin with a Phase III trial in first-line triple-negative breast cancer (TNBC). The collaboration does not include upfront payments, milestone payments, or royalty sharing provisions. In October 2026, HARMONi-GI1, an Akeso-sponsored Phase III study evaluating ivonescimab plus chemotherapy in patients with BTC, was presented as part of the Presidential Symposium at the 2026 European Society for Medical Oncology Annual Congress (ESMO 2026). Ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in OS when compared to durvalumab in combination with chemotherapy, with a hazard ratio of 0.75 (95% CI: 0.61, 0.92; p=0.0031). In the HARMONi-GI1 study, ivonescimab plus chemotherapy demonstrated an acceptable and manageable safety pro was consistent with previous Phase III studies of ivonescimab plus chemotherapy. No additional safety signals were identified. Summit plans to continue further expansion of the global clinical development program for ivonescimab, including additional Phase III studies, in additional settings and tumor types. The company will continue to provide more details in the coming months with respect to additional Phase III studies evaluating ivonescimab beyond NSCLC, CRC, UC, RCC, BTC, and head and neck squamous cell carcinoma (HNSCC). In addition to the multiregional studies conducted and sponsored by Summit, Akeso is enrolling several single-region Phase III studies exclusively in China in multiple indications outside of NSCLC, including BTC, TNBC, HNSCC, small cell lung cancer, CRC, and pancreatic cancer. Summit’s clinical trial collaborations continue to progress as planned. In the second quarter of 2025, the company announced a clinical collaboration with Revolution Medicines, Inc. (RevMed) to evaluate ivonescimab in combination with three RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805), and G12C-selective inhibitor elironrasib (RMC-6291), in solid tumor settings with RAS mutations. As previously announced, the initial study under this collaboration, sponsored by RevMed, began enrolling patients in the first quarter of 2026. In the first quarter of 2026, Summit announced a clinical collaboration with GORTEC, a European Head and Neck Oncology and Radiotherapy Group based in France, to evaluate ivonescimab monotherapy and ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, against monotherapy pembrolizumab in a randomized three-arm study. The Phase III study, GORTEC 2024-04 ILLUMINE (NCT07264075), is sponsored by GORTEC and is intended to be conducted in multiple countries in Europe and in China; Summit may consider the expansion of this study into the United States. ILLUMINE began enrolling patients in the second quarter of 2026. In the first quarter of 2026, the company announced a clinical collaboration with GSK plc to evaluate ivonescimab in combination with GSK’s novel B7-H3 ADC, risvutatug rezetecan, in multiple solid tumors. The initial study under this collaboration agreement is currently enrolling. In July 2026, Summit announced a clinical collaboration with Arcus Biosciences, Inc. to evaluate ivonescimab in combination with Arcus’ novel HIF-2α inhibitor, casdatifan, in ccRCC. Initial data from the study under this collaboration agreement is expected to be generated by mid-2027. In September 2026, as noted above, Summit announced a clinical collaboration with AstraZeneca to evaluate ivonescimab in combination with sone-ve in certain gastrointestinal cancer settings. In October 2026, as noted above, Summit announced a clinical trial collaboration with AstraZeneca and Daiichi Sankyo to evaluate ivonescimab in combination with Datroway® across multiple solid tumor settings, intended to include breast and lung cancer. The companies intend to begin with a Phase III trial in first-line TNBC. In October, 2026, Summit announced a clinical collaboration with ECOG-ACRIN Cancer Research Group to evaluate ivonescimab in combination with chemotherapy compared to pembrolizumab or durvalumab in combination with chemotherapy in advanced biliary tract cancer (BTC) in a registration-enabling Phase II / III clinical study, EA2251. The primary endpoint for the study is OS and activation of U.S. clinical trial sites is expected to begin in the fourth quarter of 2026. Clinical trial collaborations and investigator sponsored trials (ISTs) with leading academic organizations, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumors. Summit has agreed to support more than 65 ISTs, of which 26 have started and are actively enrolling. Financial Highlights On October 5, 2026, AstraZeneca completed a $2.0 billion strategic equity investment in Summit. The equity investment will support continued acceleration of the development of ivonescimab. Pursuant to the terms of the Securities Purchase Agreement entered into by Summit and AstraZeneca, AstraZeneca purchased an aggregate of approximately 108,955 shares of preferred stock convertible into shares of common stock of Summit at a 1:1,000 ratio. The investment by AstraZeneca totaled $2.0 billion. At the conversion ratio, the investment represents a common stock price equal to $18.36, representing a premium over the closing trading price on the day the investment was announced. For additional details on the financial terms, please refer to the Summit press release issued on September 28, 2026. Third quarter 2026 financial highlights are as follows: Cash and Cash Equivalents and Short-term Investments Aggregate cash and cash equivalents and short-term investments were $629.8 million and $713.4 million at September 30, 2026 and December 31, 2025, respectively. During the third quarter of 2026, the company raised $94.1 million in gross proceeds through its ATM facility. GAAP and Non-GAAP Operating Expenses GAAP operating expenses were $214.6 million for the third quarter of 2026, compared to $234.2 million for the same period of the prior year. The decrease in GAAP operating expenses was due to the decrease in stock-based compensation expense of $83.1 million primarily related to the modification to the company's performance-based stock option awards during the second quarter of 2025, offset by an increase primarily in R&D expenses driven by the expansion of clinical studies and development costs related to ivonescimab. Non-GAAP operating expenses were $166.9 million for the third quarter of 2026, compared to $103.4 million for the same period of the prior year. The increase in Non-GAAP operating expenses was primarily driven by the expansion of clinical studies and development costs related to ivonescimab. GAAP and Non-GAAP Research and Development (R&D) Expenses GAAP R&D expenses were $169.1 million for the third quarter of 2026, compared to $131.1 million for the same period of the prior year. The increase was driven by the expansion of clinical studies and development costs related to ivonescimab, offset by the decrease in stock-based compensation expense of $16.7 million primarily related to the modification to the company's performance-based stock option awards during the second quarter of 2025. Non-GAAP R&D expenses were $145.2 million for the third quarter of 2026, compared to $90.5 million for the same period of the prior year. The increase was primarily driven by the expansion of clinical studies and development costs related to ivonescimab. GAAP and Non-GAAP General and Administrative (G&A) Expenses GAAP G&A expenses were $45.5 million for the third quarter of 2026, compared to $103.1 million for the same period of the prior year. The decrease was due to the decrease in stock-based compensation expense of $66.4 million primarily related to the modification to the company's performance-based stock option awards during the second quarter of 2025. Non-GAAP G&A expenses were $21.7 million for the third quarter of 2026, compared to $12.9 million for the same period of the prior year. The increase was primarily driven by the expansion of infrastructure and our headcount to support the development of ivonescimab. GAAP and Non-GAAP Net Loss GAAP net loss in the third quarter of 2026 and 2025 was $208.4 million or $(0.26) per basic and diluted share, and $231.8 million or $(0.31) per basic and diluted share, respectively. Non-GAAP net loss in the third quarter of 2026 and 2025 was $160.7 million or $(0.20) per basic and diluted share, and $101.0 million or $(0.13) per basic and diluted share, respectively. Summit Therapeutics Update Conference Call Given the FDA's November 14 PDUFA goal action date for the pending BLA, Summit plans to host a conference call and webcast following the FDA's action. Following the FDA’s action and prior to the call, Summit will issue a press release with the conference call details, including dial-in information, which will also be posted on the Investor Relations section of Summit's website, Slides will be displayed during the live webcast, and all interested parties are encouraged to listen in. An archived replay will be available on the website shortly after the call. About Ivonescimab Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al , iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets. Contacts Contact Summit Investor Relations: Nathan LiaBraaten Senior Director, Investor Relations Tracy Jones Director, Media & Public Relations investors@smmttx.com media@smmttx.com Read full story here

Phase 3Phase 2Clinical ResultLicense out/in

100 Deals associated with Durvalumab

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KEGG	Wiki	ATC	Drug Bank
D10808	Durvalumab	L01FF03	DB11714

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	United States	AstraZeneca UK Ltd.	28 May 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
Gastroesophageal junction adenocarcinoma	United States	AstraZeneca UK Ltd.	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

Developing

10 top R&D records.

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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
MSS/pMMR/MSI-L Solid Tumor	Phase 3	Spain	AstraZeneca PLC	30 Dec 2024
Advanced Neuroendocrine Carcinoma	Phase 3	Japan	AstraZeneca KK	01 Dec 2023
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	Japan	AstraZeneca KK	01 Dec 2023
Small Cell Carcinoma	Phase 3	Japan	AstraZeneca KK	01 Dec 2023
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

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AASLD2026	Not Applicable	Hepatocellular Carcinoma First line	1,487	Durvalumab-based regimens	yvfssndqjg(mchpqdjquu) = cetzqsowls blufjpxrgl (gbgupfzjxz ) View more	Positive	05 Nov 2026
				atezolizumab+bevacizumab	txzcnehyct(smpfzltlhy) = gurniuzmlu tpquxpvcsk (qckruhriws )
AASLD2026	Not Applicable	Unresectable Hepatocellular Carcinoma First line	90	Tremelimumab plus durvalumab	ibqdylmdjr(qwqoayjgxb) = foxbsiwjzk ofnhzdmebo (mkbqpgcelt, 1.5 - 5.9) View more	Positive	05 Nov 2026
				Tremelimumab plus durvalumab (patients with Vp4 PVTT)	lkrfosvchf(pphzfryuqr) = wwqrflhyya ytfqbltblf (bnvcrtpjid ) View more
AASLD2026	Not Applicable	Unresectable Intrahepatic Cholangiocarcinoma TP53 mutations	41	gemcitabine, cisplatin, and durvalumab (GCD) or gemcitabine, cisplatin, and pembrolizumab (GCP)	inpdfgpkik(xqoglltokr) = bfoeoktjup uaripcrggh (hufdpfbfqh, 4.4 - 10.7) View more	Positive	05 Nov 2026
				gemcitabine, cisplatin, and durvalumab (GCD) or gemcitabine, cisplatin, and pembrolizumab (GCP) (TP53 wild-type ICC)	inpdfgpkik(dfpxlgwxiv) = nabcdaamcn fhueiwsjtm (cdrklpmnyf, 4.4 - 10.7) View more
AASLD2026	Phase 2/3	Advanced biliary tract cancer First line	3,000	Durvalumab + Gemcitabine + Cisplatin	jvhzltmpat(premmnavqc): HR = 0.74 (95.0% CI, 0.63 - 0.87)	Positive	05 Nov 2026
				Pembrolizumab + Gemcitabine + Cisplatin
NCT03704480 (IMMUNO-BIL, ESMO2026)	Phase 2	Biliary Tract Neoplasms Second line	80	durvalumab + tremelimumab	kmsvhiojea(dzjhmyvpui) = fnhbevpmfs dlpepkvfjm (aafvrlucbx ) View more	Positive	23 Oct 2026
NCT03732677 (NIAGARA, ESMO2026)	Phase 3	Muscle Invasive Bladder Carcinoma Neoadjuvant	1,063	Durvalumab + gemcitabine-cisplatin NAC + RC	mfzfzeuymg(vxzzggiwck) = nhxchbpdjk rspfnygfud (vbyfbcdacf )	Positive	23 Oct 2026
				Gemcitabine-cisplatin NAC + RC	mfzfzeuymg(vxzzggiwck) = fmwpvvfmko rspfnygfud (vbyfbcdacf )
NCT05128630 (DEDALUS, ESMO2026)	Phase 2	Non-small cell lung cancer stage III	25	sequential chemo-durvalumab	vyyooopnqy(czbwzpmxlz) = glshngcneq qjilupccfr (xriptpfhdg, 10.7 - 18.6) View more	Positive	23 Oct 2026
				sequential chemo-durvalumab (patients who started maintenance without progression)	vyyooopnqy(czbwzpmxlz) = ykjaarqetv qjilupccfr (xriptpfhdg ) View more
ESMO2026	Not Applicable	Biliary Tract Neoplasms Neoadjuvant	89	gemcitabine/cisplatin	bcqrgmtsjs(ppwcarrwxl) = fslxutiqte sjerhftcmp (klkxunfisw ) View more	Positive	23 Oct 2026
EUCTR2021-004411-11-DE (NeoTreme, ESMO2026)	Phase 2	Intrahepatic Cholangiocarcinoma Neoadjuvant	31	Gemcitabine + Cisplatin + Durvalumab + Tremelimumab	rhglggpemq(bcqihfufgl) = kgqfgefsqa ppxdbmmnlt (zhqmnucval ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	Biliary Tract Neoplasms First line	963	cisplatin-gemcitabine-durvalumab (Very Early Chemotherapy Discontinuation (vECD))	ojysmvlqel(bzgjnyewxx) = sozslcnrmd fpyyoxcnjf (aoivycwibh ) View more	Positive	23 Oct 2026
				cisplatin-gemcitabine-durvalumab (Early Chemotherapy Discontinuation (ECD))	ojysmvlqel(bzgjnyewxx) = jatfipskbo fpyyoxcnjf (aoivycwibh ) View more

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