Last update 03 Jul 2024

Durvalumab

Last update 03 Jul 2024

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

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [12]

Active Indication

Mismatch repair-deficient Endometrial CarcinomaNon-small cell lung cancer stage IIIAdvanced Hepatocellular Carcinoma+ [162]

Inactive Indication

Acute Myeloid LeukemiaAdvanced Colorectal AdenocarcinomaAdvanced Head and Neck Carcinoma+ [39]

Originator Organization

AstraZeneca UK Ltd.

Active Organization

AstraZeneca PLC

AstraZeneca Investment (China) Co. Ltd.

National Cancer Institute

+ [16]

Inactive Organization

Eli Lilly & Co.

Advaxis, Inc.

Mirati Therapeutics, Inc.

+ [8]

Drug Highest PhaseApproved

First Approval Date

US (01 May 2017),

Transitional Cell Carcinoma

RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (AU)

Gene Sequence

Sequence Code 10069506H

Source: *****

Sequence Code 13384675L

Source: *****

826

Clinical Trials associated with Durvalumab

NCT06050252 / RecruitingPhase 2IIT

A Phase II Trial of Durvalumab With Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma

This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.

Start Date26 Nov 2024

Sponsor / Collaborator

National Cancer Institute

NCT06284317 / Not yet recruitingPhase 3

An International, Multicentre, Open-label Randomised Phase III Trial to Evaluate the Benefit of Adding Adjuvant Durvalumab After Neoadjuvant Chemotherapy Plus Durvalumab in Patients With Stage IIB-IIIB (N2) Resectable NSCLC

ADOPT-LUNG is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.

Start Date01 Oct 2024

Sponsor / Collaborator

European Thoracic Oncology Platform

NCT06419179 / Not yet recruitingPhase 2IIT

A Multicenter Phase II Trial of Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in Homologous Recombination Deficiency (HRD) Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)

Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC)

Start Date01 Sep 2024

Sponsor / Collaborator

University of Cologne Executive School GmbH

[+1]

100 Clinical Results associated with Durvalumab

100 Translational Medicine associated with Durvalumab

100 Patents (Medical) associated with Durvalumab

1,479

Literatures (Medical) associated with Durvalumab

01 Mar 2024·Gynecologic oncology

Durvalumab with or without tremelimumab plus chemotherapy in HRR non-mutated, platinum-resistant ovarian cancer (KGOG 3045): A phase II umbrella trial

Article

Author: Lee, Sungyoung ; Choi, Chel Hun ; Park, Eunhyang ; Kim, Yoo-Na ; Chung, Jongsuk ; Park, Junsik ; Kim, Jae-Weon ; Lee, Jung-Yun ; Kim, Hee Seung ; Lee, Jung Bok ; Kim, Sunghoon ; Kim, Se Ik ; Kim, Byoung-Gie ; Lim, Jinyeong ; Joung, Je-Gun

AIM:

We investigated the efficacy and safety of durvalumab (D) with or without tremelimumab (T) in addition to single-agent chemotherapy (CT) in patients with platinum-resistant recurrent ovarian cancer (PROC) lacking homologous recombination repair (HRR) gene mutations.

PATIENTS AND METHODS:

KGOG 3045 was an open-label, investigator-initiated phase II umbrella trial. Patients with PROC without HRR gene mutations who had received ≥2 prior lines of therapy were enrolled. Patients with high PD-L1 expression (TPS ≥25%) were assigned to arm A (D + CT), whereas those with low PD-L1 expression were assigned to arm B (D + T75 + CT). After completing arm B recruitment, patients were sequentially assigned to arms C (D + T300 + CT) and D (D + CT).

RESULTS:

Overall, 58 patients were enrolled (5, 18, 17, and 18 patients in arms A, B, C, and D, respectively). The objective response rates were 20.0, 33.3, 29.4, and 22.2%, respectively. Grade 3-4 treatment-related adverse events were observed in 20.0, 66.7, 47.1, and 66.7 of patients, respectively, but were effectively managed. Multivariable analysis demonstrated that adding T to D + CT improved progression-free survival (adjusted HR, 0.435; 95% CI, 0.229-0.824; P = 0.011). Favorable response to chemoimmunotherapy was associated with MUC16 mutation (P = 0.0214), high EPCAM expression (P = 0.020), high matrix remodeling gene signature score (P = 0.017), and low FOXP3 expression (P = 0.047). Patients showing favorable responses to D + T + CT exhibited significantly higher EPCAM expression levels (P = 0.008) and matrix remodeling gene signature scores (P = 0.031) than those receiving D + CT.

CONCLUSIONS:

Dual immunotherapy with chemotherapy showed acceptable response rates and tolerable safety in HRR non-mutated PROC, warranting continued clinical investigation.

01 Mar 2024·Neoplasia (New York, N.Y.)

Machine Learning-assisted immunophenotyping of peripheral blood identifies innate immune cells as best predictor of response to induction chemo-immunotherapy in head and neck squamous cell carcinoma – knowledge obtained from the CheckRad-CD8 trial

Article

Author: Donaubauer, Anna-Jasmina ; Brunner, Thomas B ; Laban, Simon ; Fleischmann, Maximilian ; Zhou, Jian-Guo ; Klautke, Gunther ; Fietkau, Rainer ; Iro, Heinrich ; Tianyu, Xie ; Gaipl, Udo S ; Hautmann, Matthias G ; Frey, Benjamin ; Tamaskovics, Bálint ; Gostian, Antoniu-Oreste ; Kist, Andreas M ; Illmer, Thomas ; Döllinger, Michael ; Eckstein, Markus ; Hecht, Markus ; Becker, Ina ; Hartmann, Arndt

PURPOSE:

Individual prediction of treatment response is crucial for personalized treatment in multimodal approaches against head-and-neck squamous cell carcinoma (HNSCC). So far, no reliable predictive parameters for treatment schemes containing immunotherapy have been identified. This study aims to predict treatment response to induction chemo-immunotherapy based on the peripheral blood immune status in patients with locally advanced HNSCC.

METHODS:

The peripheral blood immune phenotype was assessed in whole blood samples in patients treated in the phase II CheckRad-CD8 trial as part of the pre-planned translational research program. Blood samples were analyzed by multicolor flow cytometry before (T1) and after (T2) induction chemo-immunotherapy with cisplatin/docetaxel/durvalumab/tremelimumab. Machine Learning techniques were used to predict pathological complete response (pCR) after induction therapy.

RESULTS:

The tested classifier methods (LDA, SVM, LR, RF, DT, and XGBoost) allowed a distinct prediction of pCR. Highest accuracy was achieved with a low number of features represented as principal components. Immune parameters obtained from the absolute difference (lT2-T1l) allowed the best prediction of pCR. In general, less than 30 parameters and at most 10 principal components were needed for highly accurate predictions. Across several datasets, cells of the innate immune system such as polymorphonuclear cells, monocytes, and plasmacytoid dendritic cells are most prominent.

CONCLUSIONS:

Our analyses imply that alterations of the innate immune cell distribution in the peripheral blood following induction chemo-immuno-therapy is highly predictive for pCR in HNSCC.

01 Mar 2024·Journal of geriatric oncology

Real world efficacy and toxicity of consolidation durvalumab following chemoradiotherapy in older Australian patients with unresectable stage III non-small cell lung cancer

Article

Author: Wei, Joe ; Blinman, Prunella ; Nagrial, Adnan ; Stevens, Samuel ; Yip, Po Yee ; Bray, Victoria ; Kao, Steven ; Boyer, Michael ; Nindra, Udit ; Pal, Abhijit ; Lee, Jenny ; Shahnam, Adel ; Linton, Anthony

INTRODUCTION:

Consolidation durvalumab following platinum-based chemoradiotherapy (CRT) significantly improved overall survival for patients with unresectable stage III non-small cell lung cancer (NSCLC) in the PACIFIC trial. However, older patients were underrepresented in PACIFIC, and subsequent analyses suggested trends toward poorer survival and increased toxicity in patients aged ≥70 years old. We assessed the effectiveness and safety of consolidation durvalumab following CRT in older Australian patients with unresectable stage III NSCLC.

MATERIALS AND METHODS:

This retrospective observational study was conducted across seven sites in Sydney, Australia between January 2018 and September 2021. All adult patients with unresectable stage III NSCLC who received platinum-based chemoradiotherapy followed by at least one cycle of consolidation durvalumab were included. Older patients were defined as being ≥70 years old.

RESULTS:

Of 152 patients included in the analysis, 42.8% (n = 67) patients were 70 years or older. Median follow-up was 26.1 months. The two-year overall survival and median PFS was similar between older and younger patients. At two years, 74.8% (95% confidence interval [CI]: 65.4-84.2%) of patients <70 years old and 65.2% (95% CI: 53.4-77.0%) of older patients were alive (p = 0.07; hazard ratio [HR] 1.64, 95% CI: 0.95-2.81). Median progression-free survival (PFS) in patients <70 years was 30.3 months (95% CI: 22.2-38.4 months) compared with 26.7 months (95% CI: 12.8-40.6 months) in older patients (p = 0.22; HR 1.46, 95% CI: 0.80-2.65). Toxicity was also similar, with 11.5% of patients <70 years old and 18.5% of older patients experiencing grade 3-4 adverse events (AEs; p = 0.23); 16.1% and 24.6% of the patients, respectively, discontinued treatment due to toxicity (p = 0.19). Grade 3-4 AEs and treatment discontinuation were associated with Charlson Comorbidity Index >5 (p = 0.011) and chronic obstructive pulmonary disease diagnosis at presentation (p = 0.002), respectively.

DISCUSSION:

Older Australian patients receiving consolidation durvalumab following CRT experienced comparable outcomes to their younger peers. Comorbidity burden may be more important determinants of treatment tolerance than chronological age.

529

News (Medical) associated with Durvalumab

01 Jul 2024

·www.biospace.com

FDA Action Alert: Arcutis, Orexo, Phantom and More

Pictured: A scientist with pill bottles in front of FDA headquarters/Taylor Tieden for BioSpace Coming off of a busy month, July is looking relatively quiet for the FDA, with only five big target action dates and one pivotal advisory committee meeting. Read below for more. Arcutis Proposes New Atopic Dermatitis Cream for Patients as Young as Six By July 7, the FDA is expected to release its verdict on Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA), seeking approval for a 0.15% formulation of roflumilast cream for the treatment of atopic dermatitis in patients as young as 6 years. Roflumilast is a topical inhibitor of the phosphodiesterase 4 (PDE4) enzyme, which plays a role in increasing the production of pro-inflammatory mediators while dampening the body’s anti-inflammatory mechanisms. A 0.3% formulation of roflumilast is approved under the brand name Zoryve for the treatment of psoriasis in patients 6 years and older. The FDA in December 2023 expanded roflumilast’s indication, allowing its use for seborrheic dermatitis in patients aged 9 and above. Arcutis is backing roflumilast’s atopic dermatitis application with data from three Phase III programs, including INTEGUMENT-1 and INTEGUMENT-2, two identical parallel-group, double-blinded and vehicle-controlled studies. The 0.15% roflumilast cream aced these two studies, hitting four-week success rates of 32.0% and 28.9%, respectively. In January 2024, Arcutis released additional pooled analysis from these two trials, demonstrating that 91.5% of patients treated with 0.15% roflumilast saw an improvement in the Eczema Area and Severity Index, measured at 4 weeks. Roflumilast’s data package also included a Phase II dose-ranging study and a Phase I pharmacokinetic trial. Orexo’s Opioid Overdose Drug Awaits FDA Verdict Orexo AB is proposing its high-dose naloxone drug candidate OX124 as a nasal rescue treatment for opioid overdose. The FDA’s deadline for a decision is July 15. Originally approved under the brand name Narcan, naloxone is a well-known treatment for opioid overdose. Currently available as an injectable and as a nasal spray, it works by competing with opioids for the same receptor sites, thereby undoing and dampening the drugs’ effects. Naloxone is effective at reversing the respiratory depression, hypotension and sedation often seen in patients who overdose on opioids. Orexo’s investigational formulation of naloxone makes use of its “world-class drug delivery platform,” dubbed amorphOX, according to the company’s news release accompanying the acceptance of its NDA. Through amorphOX, Orexo delivers a powder formulation of naloxone that is rapidly absorbed, highly bioavailable and highly stable. AmorphOX also makes naloxone more convenient and easier to use for patients, according to the company, making the product more robust to temperature changes. For instance, its efficacy is unaffected even if stored at freezing temperatures. If approved, Orexo expects to kick off commercial activities in the second half of this year, with a broader retail launch scheduled in early 2025, CEO Nikolaj Sørensen said in a statement. Phathom Pushes Voquezna into Heartburn in GERD The FDA is reviewing Phathom Pharmaceuticals’ application to use its oral drug Voquezna (vonoprazan) for the treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD). Its decision is due on July 19. Afflicting around 38 million adults in the U.S., non-erosive GERD is the most common type of GERD and is characterized by reflux symptoms without mucosal erosions in the esophagus. Among its most common signs is episodic heartburn, which typically occurs at night. Patients with non-erosive GERD also suffer from regurgitation and chest pain and often have trouble swallowing. Voquezna, a potassium-competitive acid blocker, works by suppressing acid secretion and acts with preference on parietal cells found in the stomach. This mechanism of action helped the drug win its first FDA approval in November 2023, allowing its use for the treatment of erosive GERD and the relief of heartburn in erosive GERD. The NDA, which Phathom filed in September 2023, is backed by a randomized, placebo-controlled and double-blinded trial with 772 enrolled patients. Results showed that both the 10-mg and 20-mg doses of Voquezna aced the trial's primary endpoint, resulting in a 45% and 44% mean percentage of heartburn-free days over the 4-week treatment period, respectively, whereas this figure was only 28% in placebo comparators. During the study’s 20-week extension phase, the mean percentage of heartburn-free days in the 10-mg and 20-mg treatment groups increased to 62% and 63%, respectively. Alpha Cognition Targets Second Oral Alzheimer’s Drug of the Past Decade By July 27, the FDA is set to release its decision on Alpha Cognition’s NDA for ALPHA-1062, a next-generation acetylcholinesterase inhibitor being proposed for the treatment of mild-to-moderate Alzheimer’s disease. Formulated as a delayed-release oral tablet, ALPHA-1062 is the prodrug of an already-approved acetylcholinesterase inhibitor, galantamine, according to Alpha Cognition. The candidate works through a similar pathway, boosting the activity of acetylcholine on nicotinic receptors and the cholinergic neurotransmission in the central nervous system, in turn inducing cognitive improvements. Compared with galantamine, however, ALPHA-1062 promises a cleaner safety profile. It carries additional benzoyl ester moieties, which allow it to bypass acetylcholine receptors in the gastrointestinal nervous system, thereby avoiding the unwanted stimulation of local neurons and reducing side effects, according to Alpha Cognition’s website. ALPHA-1062’s NDA, which the FDA accepted in December 2023, is supported by studies establishing the bioequivalence of the drug candidate to galantamine. If approved, ALPHA-1062 would be the second oral Alzheimer’s therapy in a decade, according to a February 2024 release from Alpha Cognition. Xspray Tries Again for CML Therapy Dasynoc In February 2024, the FDA accepted Xspray Pharma’s NDA resubmission for Dasynoc (dasatinib), being proposed for the treatment of chronic myeloid leukemia. The regulator’s verdict is due on July 31. According to Xspray’s news release alongside the NDA’s acceptance, Dasynoc is an “optimized version” of Bristol Myers Squibb’s dasatinib, which the pharma sells under the brand name Sprycel. For instance, Dasynoc is unaffected by stomach pH and can be used together with omeprazole, as per Xspray’s website. Dasynoc also has a more consistent uptake pro can be given at lower doses than Sprycel. In July 2023, the FDA rejected Xspray’s initial bid to win approval for Dasynoc. At the time, the regulator accepted the proposed brand name and did not identify deficiencies with the application’s stability and clinical data. Instead, the FDA requested additional information regarding Dasynoc’s dosing in order to avoid confusion among doctors and patients. The regulator also asked for more information regarding a third-party manufacturer. In a February 2024 news release, CEO Per Andersson said that despite the initial rejection, Xspray remains “on track” to launch Dasynoc on September 1, if approved. FDA’s ODAC Convenes to Discuss AstraZeneca’s Imfinzi Regimen in NSCLC On July 25, the FDA’s Oncologic Drugs Advisory Committee will meet to discuss AstraZeneca’s supplemental Biologics License Application for its antibody therapy Imfinzi (durvalumab) for the treatment of resectable non-small cell lung cancer (NSCLC). The panel of external experts will evaluate AstraZeneca’s application for neoadjuvant treatment with Imfinzi and chemotherapy, followed by Imfinzi monotherapy after surgery. The advisory committee will also evaluate whether the pharma should be required to justify Imfinzi treatment before and after surgery. Imfinzi is a monoclonal antibody designed to target and block the PD-L1 protein, in turn inhibiting its downstream signaling cascade. This mechanism hampers cancer cells’ ability to weaken and evade the immune system, while also boosting the body’s innate anti-cancer activity. The FDA first approved Imfinzi in May 2017 for the treatment of advanced bladder cancer. The treatment has since been indicated for several other cancers, including unresectable stage III NSCLC, biliary tract cancer, pancreatic cancer and advanced or recurrent endometrial cancer. In April 2023, AstraZeneca published data from the Phase III AEGEAN study showing that neoadjuvant Imfinzi with chemotherapy, followed by maintenance Imfinzi monotherapy, significantly improved event-free survival in patients with resectable early-stage NSCLC versus chemotherapy alone. The Imfinzi-based regimen also resulted in a significantly higher pathologic complete response. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Phase 3Clinical ResultDrug ApprovalPhase 2NDA

26 Jun 2024

·pmlive.com

AstraZeneca’s Imfinzi combination shows promise in phase 3 bladder cancer study

AstraZeneca (AZ) has shared positive results from a late-stage study of its Imfinzi (durvalumab) combination in muscle-invasive bladder cancer (MIBC). The phase 3 NIAGARA trial randomised more than 1,000 MIBC patients to receive Imfinzi plus chemotherapy or chemotherapy alone prior to bladder removal surgery, followed by Imfinzi or no further treatment. The Imfinzi/chemotherapy combination demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy, AZ said. It added that Imfinzi was generally well-tolerated and that no new safety concerns were observed in the neoadjuvant or adjuvant setting. More than 614,000 patients globally are diagnosed with bladder cancer every year and MIBC, named for its growth into the muscle wall of the bladder, accounts for about one in four cases. Approximately half of patients who undergo bladder removal surgery experience disease recurrence and AZ has outlined that treatment options that prevent disease recurrence after surgery are “critically needed”. Susan Galbraith, executive vice president, oncology research and development, AZ, said the results from NIAGARA support the company’s strategy to “move immunotherapy to the early stages of cancer treatment”. “This perioperative regimen with Imfinzi improved survival and reduced the rate at which patients experience disease recurrence or progression,” she added. “We are eager to bring this regimen with the potential to transform the standard of care to patients as soon as possible.” Imfinzi, which already holds approvals in lung cancer, biliary tract cancer, endometrial cancer and hepatocellular carcinoma, is a human monoclonal antibody designed to block the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses. The therapy was approved by the US Food and Drug Administration earlier this month as part of a combination regimen with carboplatin and paclitaxel to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient. The regulator’s decision was supported by positive results from the late-stage DUO-E trial, in which the Imfinzi combination reduced the risk of disease progression or death by 58% versus chemotherapy alone.

Clinical ResultPhase 3ImmunotherapyDrug Approval

25 Jun 2024

·pipelinereview.com

Update on ADJUVANT BR.31 Phase III trial of Imfinzi in non-small cell lung cancer

LONDON, UK I June 25, 2024 I High-level results from the ADJUVANT BR.31 Phase III trial, sponsored by the Canadian Cancer Trials Group (CCTG), showed Imfinzi (durvalumab) did not achieve statistical significance for the primary endpoint of disease-free survival (DFS) versus placebo in early-stage (IB-IIIA) non-small cell lung cancer (NSCLC) after complete tumour resection in patients whose tumours express PD-L1 on 25% or more tumour cells. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “We are disappointed in the ADJUVANT BR.31 results. Imfinzi has helped change the treatment landscape and achieved multiple positive Phase III trials for patients with earlier stages of lung cancer. We are committed to addressing the remaining unmet need in lung cancer through our broad development programme.” The safety profile for Imfinzi was consistent with its known safety profile, and no new safety concerns were reported. The data will be shared at a forthcoming medical meeting. Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase III trial. Imfinzi is also being investigated as monotherapy and in combinations in several other early-stage lung cancer settings, including in medically inoperable or unresected Stage I-II NSCLC (PACIFIC-4) and unresectable, Stage III NSCLC (PACIFIC-5, 8 and 9). Notes Lung cancer Each year, there are an estimated 2.4 million people diagnosed with lung cancer globally. Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. 1-2 Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% of patients diagnosed with NSCLC. 3-4 The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis. 5-6 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition. 7-8 The majority of patients with resectable disease eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy. 9 Only around 58% of patients with Stage IB disease will survive for five years. This decreases to 36-46% for patients with Stage II and 24% for patients with Stage IIIA disease, reflecting a high unmet medical need. 10 ADJUVANT BR.31 ADJUVANT BR.31 is a randomised, multi-centre, double-blind Phase III trial sponsored by CCTG evaluating Imfinzi in the adjuvant treatment of 1,415 patients with Stage IB (≥4cm), II or IIIA (Seventh Edition AJCC Cancer Staging Manual) NSCLC following complete tumour resection with or without adjuvant chemotherapy. AstraZeneca provided Imfinzi and support for the trial. Patients were randomised 2:1 to receive a 20mg/kgIV infusion of Imfinzi or placebo every four weeks for up to 48 weeks. The trial is being conducted at 269 centres across 19 countries and regions including in Canada, the US, Australia, Europe and Asia. The primary endpoint is DFS in patients whose tumours express PD-L1 on 25% or more tumour cells and do not have known common EGFR mutations or ALK rearrangements. Key secondary endpoints include DFS in patients whose tumours express PD-L1 on 1% or more of cells and in patients regardless of PD-L1 tumour cell expression status, overall survival and safety. DFS is defined as time from randomisation to date of first recurrence, new cancer or death from any cause and is recognised as an important clinical measure by both physicians and patients. Canadian Cancer Trials Group (CCTG) CCTG is an academic cancer clinical trials research cooperative that runs Phase I-III trials to test anti-cancer and supportive therapies at over 85 hospitals and cancer centres across Canada. From the operations centre at Queen’s University, CCTG has supported more than 600 trials enrolling 100,000 patients from 40 countries on 6 continents through a global network of 20,000 investigators and clinical trial staff. CCTG is a national program of the Canadian Cancer Society, and their aim is to improve survival and quality of life for all people with cancer. Imfinz i Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses. Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiation therapy. Imfinzi is also approved for the treatment of extensive-stage SCLC and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi also demonstrated statistically significant and clinically meaningful event-free survival results in patients with resectable early-stage NSCLC based on the AEGEAN Phase III trial. Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery is approved for patients in Switzerland based on this trial. In limited-stage SCLC, Imfinzi demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of OS and progression-free survival (PFS) compared to placebo in patients who had not progressed following standard-of-care concurrent chemoradiotherapy in the ADRIATIC Phase III trial. In addition to its indications in lung cancers, Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU and in combination with chemotherapy (carboplatin plus paclitaxel) followed by Imfinzi monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient in the US. Since the first approval in May 2017, more than 220,000 patients have been treated with Imfinzi . As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi and Imjudo ; Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca . References 1. World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf . Accessed June 2024. 2. World Health Organization. International Agency for Research on Cancer. World Fact Sheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/populations/900-world-fact-sheet.pdf . Accessed June 2024. 3. LUNGevity Foundation. Types of Lung Cancer. Available at: https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer . Accessed June 2024. 4. Cheema PK, et al. Perspectives on treatment advances for stage III locally advanced unresectable non-small-cell lung cancer. Curr Oncol . 2019;26(1):37-42. 5. Cagle PT, et al . Lung Cancer Biomarkers: Present Status and Future Developments. Arch Pathol Lab Med. 2013;137(9):1191-1198. 6. Le Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell Lung Cancer: Where is it Going? Ann Oncol. 2010;21(suppl 7):vii196-198. 7. Sethi S, et al. Incidental Nodule Management – Should There Be a Formal Process? J Thorac Dis . 2016:8(Suppl 6);S494-S497. 8. LUNGevity Foundation. Screening and Early Detection. Available at: https://www.lungevity.org/lung-cancer-basics/screening-early-detection . Accessed June 2024. 9. Pignon JP, et al . Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26(21):3552-3559. 10. Goldstraw P, et al. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol . 2007;2(8):706-14. SOURCE: AstraZeneca

ImmunotherapyPhase 3Clinical ResultDrug Approval

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
Mismatch repair-deficient Endometrial Carcinoma	US	AstraZeneca UK Ltd.	14 Jun 2024
Non-small cell lung cancer stage III	US	AstraZeneca UK Ltd.	14 Jun 2024
Advanced Hepatocellular Carcinoma	EU	AstraZeneca AB	14 Apr 2023
Advanced Hepatocellular Carcinoma	IS	AstraZeneca AB	14 Apr 2023
Advanced Hepatocellular Carcinoma	LI	AstraZeneca AB	14 Apr 2023
Advanced Hepatocellular Carcinoma	NO	AstraZeneca AB	14 Apr 2023
Metastatic Biliary Tract Carcinoma	EU	AstraZeneca AB	14 Apr 2023
Metastatic Biliary Tract Carcinoma	IS	AstraZeneca AB	14 Apr 2023
Metastatic Biliary Tract Carcinoma	LI	AstraZeneca AB	14 Apr 2023
Metastatic Biliary Tract Carcinoma	NO	AstraZeneca AB	14 Apr 2023
Advanced Lung Non-Small Cell Carcinoma	JP	AstraZeneca Pharmaceuticals Co., Ltd.	23 Dec 2022
Recurrent Non-Small Cell Lung Cancer	JP	AstraZeneca Pharmaceuticals Co., Ltd.	23 Dec 2022
Unresectable Biliary Tract Carcinoma	JP	AstraZeneca Pharmaceuticals Co., Ltd.	23 Dec 2022
Unresectable Hepatocellular Carcinoma	US	AstraZeneca UK Ltd.	21 Oct 2022
Advanced Lung Small Cell Carcinoma	JP	AstraZeneca Pharmaceuticals Co., Ltd.	21 Aug 2020
Hepatocellular Carcinoma	AU	AstraZeneca PLC	02 Oct 2018
Malignant Pleural Mesothelioma	AU	AstraZeneca PLC	02 Oct 2018
Locally Advanced Lung Non-Small Cell Carcinoma	EU	AstraZeneca AB	21 Sep 2018
Locally Advanced Lung Non-Small Cell Carcinoma	IS	AstraZeneca AB	21 Sep 2018
Locally Advanced Lung Non-Small Cell Carcinoma	LI	AstraZeneca AB	21 Sep 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2-negative breast cancer	Phase 3	US	National Cancer Institute	27 Nov 2023
Hormone receptor positive breast cancer	Phase 3	US	National Cancer Institute	27 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	US	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	CN	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	JP	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	AR	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	AU	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	BR	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	CA	AstraZeneca PLC	23 Nov 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	FR	AstraZeneca PLC	23 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04817826 (INFINITY, ESMO_GI2024) Manual	Phase 2	Microsatellite instability-high Stomach Cancer \| Gastroesophageal junction adenocarcinoma Neoadjuvant MSI-High	33	Tremelimumab+ Durvalumab (Cohort 1)	dhxgdgglxs(tydhffptkl) = qfqsvfjrac npepfgsham (uuotmkuzwf ) View more	Positive	27 Jun 2024
				Tremelimumab + Durvalumab (Cohort 2)	ntwfkbhury(wzsqyiyklv) = olyuilpods wbamhqmjuw (kepetkvkdq ) View more
NCT04517227 (TAD, ESMO_GI2024) Manual	Not Applicable	Unresectable Hepatocellular Carcinoma	15	durvalumab + ablation + TACE	vrylwnfltn(ptxysokiqh) = kmmpxewagv dbhhrxjsvt (lvwvlecxqh ) View more	Positive	27 Jun 2024
NCT02273375 (ADJUVANT BR.31, Company_Website) Manual	Phase 3	Non-Small Cell Lung Cancer PD-L1 Positive	-	durvalumab	ygbxwghttb(qvbpkxkwlb) = not achieve statistical significance jyeuckemdu (dbkgmrrgfv ) Not Met View more	Negative	25 Jun 2024
				Placebo
NCT03732677 (NIAGARA, Company_Website) Manual	Phase 3	Muscle Invasive Bladder Carcinoma Neoadjuvant \| Adjuvant	1,063	durvalumab+chemotherapy	hcijdzbfos(rvvruvhxom) = statistically significant and clinically meaningful improvement xcmjbpopoh (ruwchwjrqb ) Met View more	Positive	25 Jun 2024
				chemotherapy
NCT03094286 (DURVAST, CTgov)	Phase 2	Advanced Malignant Solid Neoplasm \| HIV Infections	20	Durvalumab (MEDI4736)+Durvalumab	iavutnykvm(ayenabkgus) = pzvtuswtfj nfycqmrocj (kpdpxxmipp, ngfnwddizu - dyhsukktqr) View more	-	24 Jun 2024
NCT03703297 (ADRIATIC, ASCO2024) Manual	Phase 3	Small Cell Lung Cancer Consolidation	530	Durvalumab 1500 mg + Placebo	yfjwsdfdaq(ensqrxygfd) = srxmyjpmzv hcivktfzic (zanxtnkrtb, 37.3 - not estimable) View more	Positive	02 Jun 2024
				Placebo + Placebo	yfjwsdfdaq(ensqrxygfd) = tanejfjsoe hcivktfzic (zanxtnkrtb, 25.5 - 39.9) View more
NCT03822351 (COAST, ASCO2024) Manual	Phase 2	Unresectable Lung Non-Small Cell Carcinoma	189	durvalumab	wfnmwhflen(zlogkgdbmc) = dnjqpoigza ueuilmjctx (kyoyagzezf, 14.3~35.9) View more	Positive	24 May 2024
				durvalumab+oleclumab	wfnmwhflen(zlogkgdbmc) = ocmquuleyn ueuilmjctx (kyoyagzezf, 23.1~48.4) View more
NCT03800134 (AEGEAN, ASCO2024) Manual	Phase 3	Non-Small Cell Lung Cancer EGFR \| ALK	366	Durvalumab + neoadjuvant chemotherapy	wlosogubjd(ydokryecsp): 0.63 (95% CI, 0.43 - 0.9) View more	Positive	24 May 2024
				Placebo + neoadjuvant chemotherapy
NCT03798106 (NCT03798106, ASCO2024)	Phase 1/2	Locally Advanced Soft Tissue Sarcoma PD-L1 \| PD-1	41	Doxorubicin 75mg/m2	pkokljbzun(yhtebnezlt) = qfijebaiiu hldihhzucg (rylzajqcfe, 7.6 - 40.3) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Non-Small Cell Lung Cancer	66	Chemotherapy	svuhfldejh(kgsvgruauo) = yqnxeideua chongunain (inpktwzaga ) View more	Positive	24 May 2024
				IO-containing therapy	svuhfldejh(kgsvgruauo) = dlempuskjv chongunain (inpktwzaga ) View more

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