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Last update 01 Mar 2026

Durvalumab

Last update 01 Mar 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

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

+ [10]

Target

PDL1

Action

inhibitors

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [11]

Active Indication

Early gastric cancerGastrooesophageal junction cancerLocally Advanced Gastric Carcinoma+ [208]

Inactive Indication

Adenocarcinoma of LungAdenocarcinoma of prostateAdvanced breast cancer+ [89]

Originator Organization

AstraZeneca UK Ltd.

Active Organization

Jiangsu Hailai Xinchuang Medical Technology Co., Ltd.

AstraZeneca PLC

NeoTX Therapeutics Ltd.

+ [19]

Inactive Organization

AstraZeneca GmbH

Fred Hutchinson Cancer Research Center

AVEO Pharmaceuticals, Inc.

+ [8]

License Organization

MedImmune Pharma BV

Ultimovacs ASAVall d'Hebron Institut d'Oncologia

+ [14]

Drug Highest PhaseApproved

First Approval Date

United States (01 May 2017),

Transitional Cell Carcinoma

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

Structure/Sequence

Sequence Code 10069506H

Source: *****

Sequence Code 13384675L

Source: *****

894

Clinical Trials associated with Durvalumab

NCT07288034

/ Not yet recruitingPhase 2IIT

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

This phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD[L]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Response and survival rates in advanced stage NSCLC, unlike other cancers, rely on response to first-line therapy. Immunotherapy with PD(L)1-based therapy, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. While immunotherapy has improved survival rate, the prognosis remains poor with most patients receiving chemotherapy after immunotherapy. Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid (DNA) which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. The first part of this trial, studying samples of blood and tissue in the laboratory from patients receiving immunotherapy may help doctors learn more about the effects PD(L)1-based therapy on cells. It may also help doctors understand how well patients respond to treatment and may help develop new individualized treatment strategies. The second part of this trial also tests the effect of second-line immunotherapy, such as tremelimumab and durvalumab or adagrasib and bevacizumab, in treating patients with NSCLC with specific genetic mutations that is growing, spreading or getting worse (progressive). Tremelimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adagrasib, a type of targeted therapy, may stop the growth of tumor cells by blocking a protein needed for tumor cell growth and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving second-line immunotherapy, tremelimumab and durvalumab or adagrasib with bevacizumab, may be safe, tolerable, and/or effective in treating patients with stage IIIB/IV NSCLC with specific genetic mutations.

Start Date21 Sep 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT05403723

/ SuspendedPhase 1IIT

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

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

Start Date30 Jun 2026

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

NCT05253131

/ Not yet recruitingPhase 2IIT

Phase 1/2 Trial of the MEK Inhibitor Selumetinib and Bromodomain Inhibitor ZEN-3694 With Durvalumab (MEDI4736), a PD-L1 Antibody for Sarcomas Including Malignant Peripheral Nerve Sheath Tumors

A multi-institutional open-label phase 1/2 trial of selumetinib in combination with ZEN-3694 and durvalumab in refractory/unresectable sarcomas including MPNST. The phase 1 portion will be separated in two parts and will be open to all patients with refractory/relapsed sarcomas. The phase 2 portion will be for patients with refractory/unresectable NF1-associated MPNST.

Start Date15 May 2026

Sponsor / Collaborator

The University of Alabama at Birmingham

[+1]

100 Clinical Results associated with Durvalumab

100 Translational Medicine associated with Durvalumab

100 Patents (Medical) associated with Durvalumab

2,218

Literatures (Medical) associated with Durvalumab

01 Mar 2026·LUNG CANCER

Durvalumab-containing treatment for recurrent or metastatic pulmonary sarcomatoid carcinoma: A pooled post hoc analysis of two KCSG phase II trials

Article

Author: Kim, Tae Min ; Kim, Yu Jung ; Kim, Dong-Wan ; Lee, Gyeong-Won ; Keam, Bhumsuk ; Kim, Miso ; Kim, Dong Hyun ; Kim, Joo-Hang ; Ahn, Mi Sun ; Hong, Sook-Hee ; Kim, Se Hyun ; Kim, Jin-Soo ; Shin, Seong Hoon ; Youk, Jeonghwan

INTRODUCTION:

Pulmonary sarcomatoid carcinoma (PSC) is a rare cancer characterized by a high programmed death-ligand 1 (PD-L1) expression, suggesting a potential therapeutic benefit from immune checkpoint inhibitors. We investigated the efficacy of durvalumab-containing combination therapy and explored potential predictive biomarkers in patients with recurrent or metastatic (R/M) PSC.

METHOD:

In this pooled post hoc analysis, data were integrated from two prospective phase II trials (NCT03022500 and NCT04224337) wherein durvalumab-containing combination therapies were evaluated in patients with R/M PSC. PD-L1 expression was assessed using 22C3 or SP263 assays, and circulating lymphocyte subsets were analyzed using flow cytometry.

RESULTS:

Overall, 33 patients were included, of whom 66.7 % had a PD-L1 tumor proportion score (TPS) ≥ 1 % and 45.5 % had a TPS ≥ 50 %. The overall response rate was 33.3 % (95 % confidence interval [CI], 18.0 %-51.8 %), and the disease control rate was 72.7 % (95 % CI, 54.5 %-86.7 %). The median progression-free survival and overall survival were 5.4 (95 % CI, 2.8-9.4) and 15.7 (95 % CI, 11.3-not estimated) months, respectively. PD-L1 expression was not associated with the response or survival outcomes. Patients who achieved disease control exhibited a higher proportion of circulating CD8⁺ T cells (mean, 28.5 % vs. 20.3 %, P = 0.083) and a lower CD4⁺/CD8⁺ ratio (median, 1.4 vs. 1.7, P = 0.048) than did those with progressive disease.

CONCLUSION:

Durvalumab-containing combination therapy showed promising efficacy in patients with R/M PSC, irrespective of PD-L1 expression. A lower CD4⁺/CD8⁺ ratio may be associated with favorable disease control.

01 Mar 2026·Case reports in women's health

Recurrent endometrial carcinoma with immune-mediated thrombocytopenia following durvalumab: A case report

Article

Author: Sakakibara, Ami ; Shirane, Terumi ; Sakai, Tomomi ; Nagai, Shimpei ; Hattori, Yoshihisa ; Kurahashi, Takashi ; Hino, Makiko ; Fujioka, Yoko

The use of immune checkpoint inhibitors (ICIs) has expanded the therapeutic landscape for advanced or recurrent endometrial carcinoma. Durvalumab-a programmed death-ligand 1 (PD-L1) inhibitor-demonstrated clinical benefit in the 2023 DUO-E trial when combined with carboplatin and paclitaxel. Immune thrombocytopenia (ITP) is an uncommon but potentially life-threatening immune-related adverse event (irAE). A 73-year-old woman with recurrent endometrial carcinoma developed severe ITP after three cycles of paclitaxel, carboplatin, and durvalumab. Fourteen days after cycle 3 she presented with pyelonephritis, bacteremia, and acute disseminated intravascular coagulation (DIC). Despite infection control, her platelet count declined to 1 × 10³/μL, with epistaxis, hematuria, and melena. Suspecting ITP as an irAE, intravenous immunoglobulin (IVIG 10 g/day × 5 days) and high-dose intravenous prednisolone (1 mg/kg/day) were administered. Platelet counts improved gradually to 85 × 10³/μL by hospital day 32, and she was discharged on a steroid taper. This appears to be the first Japanese report of durvalumab-associated ITP in endometrial carcinoma. Clinicians should maintain a high index of suspicion for ITP when unexpected thrombocytopenia or bleeding occurs during durvalumab therapy and initiate prompt treatment.

10 Feb 2026·JOURNAL OF CLINICAL ONCOLOGY

Erratum: Simultaneous Durvalumab and Platinum-Based Chemoradiotherapy in Unresectable Stage III Non–Small Cell Lung Cancer: The Phase III PACIFIC-2 Study

Article

Author: Jia, Nan ; Sugawara, Shunichi ; Newton, Michael ; Bielecka, Zofia F. ; Özgüroğlu, Mustafa ; Zurawski, Bogdan ; Zemanova, Milada ; Ostoros, Gyula ; Sriuranpong, Virote ; Lee, Ki Hyeong ; Janoski de Menezes, Juliana ; Demirkazik, Ahmet ; Zimmer Gelatti, Ana Caroline ; Chander, Pratibha ; Bradley, Jeffrey D.

1,165

News (Medical) associated with Durvalumab

27 Feb 2026

·www.businesswire.com

Signatera™ MRD Data at ASCO GU Highlights Potential Utility Across GU Cancers, Including for Bladder Preservation

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced it will present new data in genitourinary malignancies at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026. Across four oral presentations in muscle-invasive bladder cancer (MIBC), these data reinforce Signatera’s role in identifying patients who benefit from adjuvant immunotherapy, supporting response-adaptive bladder preservation strategies, and refining molecular residual disease (MRD) detection with plasma circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA). Bladder Preservation: INDIBLADE and RETAIN The INDIBLADE and RETAIN multicenter phase 2 trials demonstrate Signatera’s consistent performance in treatment response monitoring across diverse neoadjuvant regimens in MIBC, with 73-77% of patients demonstrating clearance of ctDNA following therapy and Signatera-negativity showing strong associations with positive outcomes, even with the bladder preserved. INDIBLADE, the findings of which will be published today in Nature Medicine, investigated induction with combination immune checkpoint inhibitors (ICI) followed by chemoradiotherapy as a bladder-sparing strategy in stage II/III MIBC patients. The results show that Signatera status post-ICI was associated with bladder-intact event-free survival (BI-EFS). Specifically, Signatera-negativity at baseline and post-neoadjuvant therapy was linked to an 88.6% and 91% estimated two-year BI-EFS, respectively. RETAIN evaluated a clinical response-adapted approach to identify patients for potential bladder-preservation following neoadjuvant therapy. The findings showed that post-treatment ctDNA clearance or negativity was associated with improved metastasis-free survival (MFS), and that Signatera-negative patients with no clinical or radiographic evidence of disease managed with active surveillance achieved MFS comparable to Signatera-negative patients undergoing cystectomy. In contrast, persistent Signatera-positivity was associated with poor outcomes. Perioperative Care: NIAGARA This phase 3 randomized perioperative study includes the first-ever presentation of utDNA data with clinical correlation. The combination of utDNA and ctDNA status post-neoadjuvant therapy and pre-cystectomy identified the group with the highest 24-month EFS. utDNA-positivity pre-cystectomy was more strongly associated with residual non-invasive disease vs ctDNA-positivity was more strongly associated with residual invasive disease. These data suggest that the combined assessment of utDNA and ctDNA can provide complementary risk stratification benchmarked against pathologic staging, enabling comprehensive identification of residual disease. “As treatment options expand in perioperative and bladder preservation settings, we need tools that help us determine who truly requires additional therapy and who may safely avoid it,” said Michiel van der Heijden, M.D., Ph.D., Netherlands Cancer Institute, principal investigator of INDIBLADE and presenting author of the NIAGARA study. “The data presented at ASCO GU demonstrate that MRD assessment with Signatera has strong correlations with outcomes and the potential to inform these critical treatment decisions.” “Following our milestone PMA submission to the FDA based on IMvigor011, these compelling data presentations reflect our commitment to transforming care across the spectrum of genitourinary malignancies,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. “The new data suggests a particularly important opportunity for Signatera to optimize clinical decisions around bladder preservation, a major opening to improve patient quality of life.” The full list of presentations at ASCO GU includes: February 27, 8:10 AM PT | Abstract #633 (Oral Presentation) Presenter: Joaquim Bellmunt, M.D. Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial February 27, 8:10 AM PT | Abstract #632 (Oral Presentation) Presenter: Pooja Ghatalia, M.D. Circulating tumor DNA (ctDNA) to guide response-adapted bladder preservation in muscle invasive bladder cancer (MIBC): Integrated analysis of the RETAIN trials February 27, 11:30 AM PT | Abstract #797 Presenter: Can Aydogdu, M.D. Integrating genomic profiling and circulating tumor DNA monitoring to optimize surveillance strategies in muscle-invasive bladder cancer February 27, 11:30 AM PT | Abstract #831 Presenter: Can Aydogdu, M.D. Association of ctDNA status with upstaging, pathologic outcomes, and genomic alterations in high-risk NMIBC February 27, 2:30 PM PT | Abstract #637 (Oral Presentation) Presenter: Jan-Jaap J. Mellema, M.D. Induction ipilimumab plus nivolumab followed by consolidating chemoradiotherapy as bladder-sparing treatment in stage II/III urothelial carcinoma of the bladder: The phase 2 INDIBLADE trial February 27, 4:00 PM PT | Abstract #636 (Oral Presentation) Presenter: Michiel van der Heijden, M.D., Ph.D. Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA February 28, 7:00 AM PT | Abstract #532 Presenter: Shuchi Gulati, M.D., M.Sc. Association of pre-operative circulating tumor DNA (ctDNA) status with clinicopathologic characteristics in patients (pts) with localized renal cell carcinoma (RCC) February 28, 7:00 AM PT | Abstract #620 Presenter: Dalia Kaakour, M.D., MPH Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer February 27, 11:30 AM PT | Abstract #860 Presenter: Lingbin Meng, M.D., Ph.D. Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer February 27, 11:30 AM PT | Abstract #800 Presenter: Tanya Jindal, BS, BA Predictive value of early circulating tumor DNA (ctDNA) response in advanced urothelial carcinoma (aUC) treated with enfortumab vedotin plus pembrolizumab (EVP). February 28, 7:00 AM PT | Abstract #541 Presenter: David F. McDermott, M.D. Circulating tumor DNA (ctDNA) analysis in participants (pts) with advanced clear cell renal cell carcinoma (ccRCC) treated with first-line pembrolizumab (pembro) monotherapy from the phase 2 KEYNOTE-427 study. About Natera Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com. Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Clinical ResultPhase 2ASCOPhase 3

27 Feb 2026

·www.fiercepharma.com

Padcev-Keytruda combo aces another bladder cancer trial as MIBC landscape becomes more complex

The Padcev-Keytruda combination looks poised to move into another earlier-stage bladder cancer setting, reporting a 35% reduction in the risk of death in the Keynote-B15 trial. The combination of Padcev and Keytruda has once again delivered strong results, this time significantly improving overall survival (OS) for patients with cisplatin-eligible muscle-invasive bladder cancer (MIBC). Yet questions remain about its impact on practice due to a changing treatment landscape.Results from the Keynote-B15 (EV-304) trial showed a major 47% reduction in patients’ risk of tumor recurrence, disease worsening or death for the Padcev-Keytruda combination compared with neoadjuvant cisplatin-based chemotherapy alone.Presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, the data also showed that using Padcev and Keytruda both before and after surgical removal of patients’ bladders lowered their risk of death by 35% compared with presurgical chemotherapy.The statistically significant OS number was gleaned during an interim analysis, when the majority of patients in both arms were still alive, study presenter Matthew Galsky, M.D., from the Mount Sinai Tisch Cancer Center, told reporters during a press briefing. As of a data cutoff on Oct. 27, 2025, 83% of patients in the perioperative combo arm, versus 75.4% of those in the control arm, were alive. “The Keynote-B15 study marks an exciting development in establishing a potential new treatment option and standard of care for these patients,” Kevin Kelly, an ASCO expert in genitourinary cancer from Thomas Jefferson University, said in a statement. Merck & Co. sponsored the study and offered Keytruda, while Pfizer and Astellas contributed Padcev, an antibody-drug conjugate. The trial win in cisplatin-eligible patients with MIBC follows a similarly positive readout from the Keynote-905 (EV-303) study, which showed the Padcev-Keytruda combo can improve survival in cisplatin-ineligible patients, leading to a groundbreaking FDA approval in November 2025.However, unlike the conclusiveness of the combo’s prowess in that previous trial, the latest triumph comes with some questions as the treatment landscape in bladder cancer has gotten more complicated—both in early-stage and metastatic settings—since the Keynote-B15 study started in 2021. By Galsky’s estimate, eligibility for cisplatin divides MIBC patients roughly 50-50. Among the uncertainties, clinicians are left wondering whether the trial’s neoadjuvant chemo-only control arm remains a relevant comparator. As Kelly noted, the study’s control arm lacked an adjuvant therapy. In August 2021, merely four months after Keynote-B15’s launch, the FDA approved Bristol Myers Squibb’s Opdivo for the adjuvant treatment of bladder cancer patients who are at high risk of recurrence after undergoing radical resection.More recently, the FDA last year blessed AstraZeneca’s Imfinzi as perioperative regimen in MIBC.Opdivo adjuvant therapy has not shown an OS benefit in bladder cancer, Galsky, who’s also the lead author of the CheckMate-274 trial that supported Opdivo’s adjuvant nod, noted during the press briefing. Last year, Galsky presented updated long-term follow-up data from the BMS trial. While OS data remained immature, adjuvant Opdivo was linked to a favorable trend toward a 27% death-risk reduction versus placebo in MIBC patients.Besides, Opdivo’s indication only covers a subset of patients at high risk of recurrence after surgery, he pointed out.As for Imfinzi, Galsky cautioned against making a cross-trial comparison, but he still pointed to some differences in the two regimens’ effect sizes. For example, on the secondary endpoint of rate of pathological complete response (pCR), which measures the absence of cancer in the resected tumor tissues, the Padcev-Keytruda cocktail reached 55.8%, versus 32.5% for the control arm in the current Keynote-B15 trial. In the Niagra trial, the Imfinzi regimen recorded a 33.8% pCR rate, versus 25.8% in the comparison group. The Niagra perioperative regimen was the first immunotherapy to deliver a survival win against cisplatin chemo for MIBC patients, showing a death-risk reduction of 25%. The regimen includes Imfinzi and cisplatin-based chemo before surgery followed by Imfinzi alone post-surgery. The Padcev-Keytruda combo foregoes any systemic chemo, leading to fewer hematological toxicities such as neutropenia, anemia and thrombocytopenia despite higher rates of skin reactions, diarrhea and hair loss, according to the Keynote-B15 results. To further complicate clinicians’ treatment decisions, Padcev-Keytruda has become the new standard of care in first-line metastatic bladder cancer, raising the possibility that some physicians might reserve the combo as an option for patients who eventually progress rather than using it upfront in early-stage MIBC.Despite this reluctance, it’s better to give patients the best treatment upfront, which improves long-term outcomes, Catherine Pietanza, M.D., vice president of global clinical development at Merck Research Laboratories, argued.Patients who receive Padcev-Keytruda as a perioperative treatment for MIBC would have to look for a different regimen if their cancer progresses to advanced disease, she acknowledged in an interview with Fierce Pharma. But that won’t be problem for all bladder cancer patients considering the PD-1/ADC combo, because only about 25% of bladder cancer patients are diagnosed at the MIBC stage, whereas the majority are first diagnosed with metastatic disease.“Having [Padcev-Keytruda] treatments in both the perioperative setting and the first-line setting allows patients to have both available to them, whether they are diagnosed in early-stage or in the metastatic setting,” Pietanza said.In another potential advantage over AZ’s Niagra regimen, as Pietanza noted, the twin triumphs of Keynote-905 and now Keynote-B15 mean that the combo, if approved in cisplatin-eligible patients, would simplify treatment for doctors as they wouldn’t have to think about whether a patient is eligible for cisplatin.There’s also the perennial question of whether all patients need treatment both before and after surgery. Galsky acknowledged that the field doesn’t have an answer to this because researchers have only recently started to think about treatment de-escalation. He raised circulating tumor DNA as a powerful tool that may be incorporated in future trials to identify patients for personalized treatment escalation.

Clinical ResultDrug ApprovalASCO

23 Feb 2026

·www.biospace.com

AIM ImmunoTech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and AstraZeneca’s Durvalumab in the Treatment of Metastatic Pancreatic Cancer

OCALA, Fla., Feb. 23, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced milestones in the expected timeline for the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen ® (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi ® (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the “DURIPANC” study) (see: ClinicalTrials.gov NCT05927142 ). DURIPANC is an investigator-initiated, exploratory, open-label, single-center study, and 18 subjects have enrolled in the study so far. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center (“Erasmus MC”) in the Netherlands. Planned DURIPANC milestones: July 2026 – Complete subject enrollment. August 2026 – Complete full Ampligen dosing for all subjects. December 2026 – Evaluation of the Primary Endpoint of Clinical Benefit Rate, defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy. June 2027 – Evaluation of the Secondary Endpoints once last subject reaches week 49 Progression-Free Survival, defined as the time between the start of combination therapy with Ampligen and durvalumab to date of progression or death, whichever occurs first. Overall Survival, defined as the time between the start of combination therapy with Ampligen and durvalumab to date of death, Immunogenic efficacy, defined as >50% increase in circulating Ki67+ CD 8+ T cell in peripheral blood evaluated 12 weeks after start of combination therapy. Infiltrating immune profile, defined as the change in infiltrating immune pro start of combination therapy. Reporting of Quality of life (EORTC QLQ-C30) based upon evaluations at baseline, 6 weeks, 3 months, 9 months and 1 year after the start of immunotherapy. AIM is committed to releasing mid-year and year-end interim progress reports on DURIPANC, with the most recent update released at the beginning of February. Lead investigator Marjolein Y. V. Homs, MD, PhD, Department of Medical Oncology, Erasmus MC Cancer Institute, emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study – which supported advancement to the ongoing Phase 2 portion of the study – continue to be seen and that enrollment is ongoing. Erasmus MC expects that detailed data will be published later this year. According to Erasmus MC, there has also been no significant toxicity – an encouraging safety pro a post-chemo setting – and Ampligen subjects are consistently reporting “high quality of life” during treatment. See : DURIPANC, Year-End Interim Clinical Progress Update Additionally, AIM has published on its website an updated corporate presentation that emphasizes the Company’s priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM’s research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM’s stockholders. The largest mergers and acquisitions deals in the biotech space often involve oncology drugs in Phase 3 clinical trials or later in development, and so AIM believes that moving Ampligen toward – and ultimately into – a Phase 3 clinical trial has great financial potential for the Company and its stockholders. See: Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer: Corporate Presentation – February 2026 About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials. Forward-Looking Statements Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in the press release speak only as of the date of the press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The Company is in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and disclosures in the Company’s reports filed with the SEC on its website and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website and in its press releases. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks. Please review the “Risk Factors” section in the Company’s latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and the Registration Statement. Its filings are available at The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only. CONTACT: Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com

Phase 2ImmunotherapyAcquisitionPhase 3

100 Deals associated with Durvalumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10808	Durvalumab	L01XC28	DB11714

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Early gastric cancer	United States	AstraZeneca PLC	25 Nov 2025
Gastrooesophageal junction cancer	United States	AstraZeneca PLC	25 Nov 2025
Locally Advanced Gastric Carcinoma	United States	AstraZeneca PLC	25 Nov 2025
Unresectable Lung Non-Small Cell Carcinoma	China	AstraZeneca UK Ltd.	18 Nov 2025
Muscle Invasive Bladder Carcinoma	United States	AstraZeneca UK Ltd.	28 Mar 2025
Uterine Neoplasms	Japan	AstraZeneca Pharmaceuticals Co. Ltd.	22 Nov 2024
Advanced Endometrial Carcinoma	European Union	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Iceland	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Liechtenstein	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Norway	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	European Union	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Iceland	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Liechtenstein	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Norway	AstraZeneca AB	15 Aug 2024
Resectable Lung Non-Small Cell Carcinoma	United Kingdom	AstraZeneca PLC	09 Jul 2024
Advanced biliary tract cancer	United States	AstraZeneca UK Ltd.	14 Jun 2024
Mismatch repair-deficient Endometrial Carcinoma	United States	AstraZeneca UK Ltd.	14 Jun 2024
Non-small cell lung cancer stage III	United States	AstraZeneca UK Ltd.	14 Jun 2024
Advanced Hepatocellular Carcinoma	European Union	AstraZeneca AB	14 Apr 2023
Advanced Hepatocellular Carcinoma	Iceland	AstraZeneca AB	14 Apr 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	NDA/BLA	Australia	AstraZeneca Pty Ltd.	11 Jun 2025
Stomach Cancer	NDA/BLA	Australia	AstraZeneca Pty Ltd.	11 Jun 2025
ALK positive Non-Small Cell Lung Cancer	NDA/BLA	China	AstraZeneca AB	21 Feb 2025
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	AstraZeneca UK Ltd.	21 Feb 2025
Ovarian Epithelial Carcinoma	NDA/BLA	China	AstraZeneca UK Ltd.	16 Aug 2024
PD-L1 positive Triple Negative Breast Cancer	Phase 3	United States	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	China	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Japan	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Argentina	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	Australia	AstraZeneca PLC	23 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04945720 (DurHope, CTgov)	Phase 2	Advanced Hepatocellular Carcinoma \| Portal Vein Thrombosis	30	FOLFOX+leucovorin+Durvalumab+oxaliplatin+fluorouracil	gjblbipcbn = uvlresmrua swxkezxbtn (csfnwhypug, qisxlfrtgm - jxrhxobcbe) View more	-	25 Feb 2026
NCT03874325 (Pubmed \| Breast Cancer Res Treat)	Phase 2	Hormone receptor positive breast cancer Neoadjuvant HR+ \| HER2-	17	Durvalumab + Aromatase Inhibitors (HR+/HER2-negative breast cancer + Postmenopausal)	miivdvzxwc(osppcifkeo) = Treatment was well tolerated, with most adverse events being grade 1-2. slszkzioad (jsgaqfgmri )	Negative	01 Feb 2026
TPAZ-1 (ASCO_GI2026)	Phase 3	Advanced Bile Duct Carcinoma First line	3,373	Gemcitabine plus cisplatin plus durvalumab	mnzjlhvdsc(yjsrggqloo): HR = 0.6 (95.0% CI, 0.55 - 0.66), P-Value = < 0.001 View more	Positive	08 Jan 2026
				Gemcitabine plus cisplatin plus pembrolizumab
TOPAZ-1 (ASCO_GI2026)	Phase 3	Advanced Bile Duct Carcinoma First line	874	Gemcitabine + cisplatin + durvalumab	ovihhkearu(ndsjakytsp) = uiftjxypge cleipnujal (oahpfzuvgk ) View more	Similar	08 Jan 2026
				Gemcitabine + cisplatin + pembrolizumab	ovihhkearu(ndsjakytsp) = lbajonhqhm cleipnujal (oahpfzuvgk ) View more
ASCO_GI2026	Not Applicable	Intrahepatic Cholangiocarcinoma \| Bile Duct Neoplasms First line	175	Durvalumab plus gemcitabine/cisplatin (CCA)	bvuahyohdl(jnmiyfwdcs) = The most common toxicities were hematologic events, with both groups demonstrating similar rates of anemia, thrombocytopenia, leukopenia, and neutropenia. mtjkuzpyzy (twumxyhzeh ) View more	Positive	08 Jan 2026
				Durvalumab plus gemcitabine/cisplatin (cHCC-CCA)
ASCO_GI2026	Not Applicable	Advanced biliary tract cancer First line	581	durvalumab + gemcitabine + cisplatin	dxzxfnfjck(gkrtuvqlid) = uxjuktaalq byrwbdaskp (yksizupidg, 0.47 - 0.63) View more	Positive	08 Jan 2026
				gemcitabine + cisplatin	dxzxfnfjck(gkrtuvqlid) = rrzhiglkxu byrwbdaskp (yksizupidg, 0.36 - 0.68) View more
NCT04592913 (MATTERHORN, ASCO_GI2026)	Phase 3	Gastroesophageal junction adenocarcinoma Adjuvant \| Neoadjuvant	948	durvalumab + FLOT	udoeprnmzv(uujwcqjxsq) = ivgrdglhsr rttgezreca (rntykuemnk ) View more	Positive	08 Jan 2026
				placebo + FLOT	udoeprnmzv(uujwcqjxsq) = mpcvsmlpdp rttgezreca (rntykuemnk ) View more
NCT06501625 (ASCO_GI2026)	Phase 1/2	IDH1 Mutation Cholangiocarcinoma First line IDH1 Mutation	7	Ivosidenib 500 mg + Durvalumab + Gemcitabine/Cisplatin	xuwnwbnofy(rewrdgazfy) = vslgzgnpok oursgokqbu (mlhdndbkts ) View more	Positive	08 Jan 2026
NCT02962063 (ASCO_GI2026)	Phase 2	Adenocarcinoma of Esophagus	20	Durvalumab + Tremelimumab + PET-directed chemoradiation	txhkpzbneb(tackybvtqy) = bkcpjznkam llhrnxgltq (yffxnvfyxp ) View more	Positive	08 Jan 2026
				Durvalumab + Tremelimumab + PET-directed chemoradiation (resected Pts)	txhkpzbneb(tackybvtqy) = jwjhashkhj llhrnxgltq (yffxnvfyxp )
ASCO_GI2026	Not Applicable	Advanced Hepatocellular Carcinoma First line	3,306	Bevacizumab-atezolizumab	rabtzdbzed(kbfttpkjds): HR = 0.873 (95.0% CI, 0.75 - 0.935), P-Value = 0.0016	Positive	08 Jan 2026
				Lenvatinib

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