Last update 21 Jun 2024

Durvalumab

Last update 21 Jun 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+ [155]

Inactive Indication

Acute Myeloid LeukemiaAdvanced Colorectal AdenocarcinomaAdvanced Head and Neck Carcinoma+ [40]

Originator Organization

AstraZeneca UK Ltd.

Active Organization

Canadian Cancer Trials Group

Circio Holding ASA

AstraZeneca PLC

+ [44]

Inactive Organization

Eli Lilly & Co.

Northwestern University

University of Colorado Denver

+ [21]

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 ; Hartmann, Arndt ; Becker, Ina

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.

522

News (Medical) associated with Durvalumab

20 Jun 2024

·pipelinereview.com

Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer

First and only AKT inhibitor approved in the EU for breast cancer patients with specific biomarker alterations (PIK3CA, AKT1 or PTEN) Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population LONDON, UK I June 20, 2024 I AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the CAPItello-291 Phase III trial published in The New England Journal of Medicine . 1 In the trial, Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% versus Faslodex in combination with placebo in patients with tumours harbouring PI3K, AKT or PTEN alterations (based on hazard ratio of 0.50, 95% confidence interval 0.38-0.65; p=<0.001; median progression-free survival (PFS) 7.3 versus 3.1 months). 1 In Europe, breast cancer remains the leading cause of cancer death, with more than 140,000 deaths in 2022 and more than 550,000 patients diagnosed in the same year. 2 Hormone receptor (HR)-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative. 3 More than 97% of HR-positive breast cancer tumours are ER-positive. 4,5 Collectively, mutations in PIK3CA, AKT1 and alterations in PTENoccur frequently, affecting approximately 50% of patients with advanced HR-positive breast cancer. 6-8 Mafalda Oliveira, MD, PhD, Vall d’Hebron University Hospital, and Senior Clinical Investigator of the Vall d’Hebron Institute of Oncology’s Breast Cancer Group in Barcelona, Spain, said: “Patients with advanced ER-positive breast cancer typically experience tumour progression or resistance with widely used endocrine-based treatment regimens, and there is an urgent need to provide them more time with their disease under control. Today’s approval is welcome news for approximately half of ER-positive breast cancer patients in Europe who have tumours with these biomarkers, and it is important for clinicians to test and identify eligible patients who may be able to benefit from this combination.” Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “ Truqap is now the first and only AKT inhibitor approved in the European Union for patients with ER-positive breast cancer who have tumours harbouring these specific biomarkers. Breast cancer continues to be the leading cause of cancer-related death in Europe, and today’s news represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies.” In the CAPItello-291 trial, the safety profile of Truqap plus Faslodex was similar to that observed in previous trials evaluating this combination. 1 Regulatory applications are currently under review in China and several other countries. Similar indications for Truqap in combination with Faslodex are already approved in the US , Japan and several other countries based on the CAPItello-291 trial. Financial considerations Following this approval in the EU, Astex Therapeutics is eligible to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the EU as well as royalties on future sales in line with the agreement between the two companies. Notes HR-positive breast cancer The growth of HR-positive breast cancer cells is often driven by estrogen receptors, and endocrine therapies that target ER-driven disease are widely used as 1st-line treatment in the advanced setting, and often paired with CDK4/6 inhibitors. 9-11 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. 10 Once this occurs, treatment options are limited– with chemotherapy being the current standard of care – and survival rates are low with approximately 35% of patients anticipated to live beyond five years after diagnosis. 3,10,12 The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research. CAPItello-291 CAPItello-291 is a Phase III, double-blind, randomised trial evaluating the efficacy of Truqap in combination with Faslodex versus placebo plus Faslodex for the treatment of locally advanced (inoperable) or metastatic HR-positive (ER-positive and ER-positive, progesterone receptor-positive), HER2-low or negative (immunohistochemistry (IHC) 0 or 1+, or IHC 2+/in-situ hybridisation (ISH)-negative) breast cancer. The global trial enrolled 708 adult patients with histologically confirmed HR-positive, HER2-low or negative breast cancer whose disease has recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor, and up to one line of chemotherapy for advanced disease. The trial has dual primary endpoints of PFS in the overall patient population and in a population of patients whose tumours have qualifying alterations in the PI3K/AKT pathway (PIK3CA, AKT1 or PTEN genes). In the trial, approximately 40% of tumours had these alterations and approximately 70% of patients received a prior CDK4/6 inhibitor. Truqap Truqap is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). Truqap 400mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition. Truqap is approved in the US, EU, Japan and several other countries for the treatment of adult patients with HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. Truqap is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results. Truqap is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments. Truqap was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited). Faslodex Faslodex is an endocrine therapy indicated for the treatment of ER-positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on anti-estrogen therapy. In the US, EU and Japan , Faslodex is also approved in combination with CDK4/6 inhibitors for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine . Faslodex represents a hormonal treatment approach that helps to slow tumour growth by blocking and degrading the estrogen receptor – a key driver of disease progression. Faslodex is approved as monotherapy or in combination with medicines from various drug classes including CDK4/6, PI3K and AKT inhibitors for the treatment of patients with HR-positive advanced breast cancer and is being evaluated in combination with medicines from other drug classes. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap , and next-generation SERD and potential new medicine camizestrant. AstraZeneca is also collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan, in this setting. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is evaluating the potential of datopotamab deruxtecan alone and in combination with immunotherapy Imfinzi (durvalumab), and Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu . 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 SOURCE: AstraZeneca

Phase 3Drug ApprovalClinical ResultImmunotherapy

20 Jun 2024

·pmlive.com

AstraZeneca’s Truqap plus Faslodex granted EC approval to treat advanced breast cancer

AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) and its endocrine therapy Faslodex (fulvestrant) have been approved by the European Commission (EC) as a combination treatment for a subset of adults with advanced breast cancer. Patients eligible for the combination will have oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with at least one PIK3CA, AKT1 or PTEN alteration and will have experienced disease recurrence or progression on or after an endocrine-based regimen. The EC’s decision follows a recent recommendation from the European Medicines Agency’s and is supported by positive results from the late-stage CAPItello-291 trial, in which Truqap plus Faslodex reduced the risk of disease progression or death by 50% compared with Faslodex alone in patients with tumours harbouring PI3K, AKT pathway or PTEN alterations. Breast cancer remains the leading cause of cancer death in Europe, where more than 550,000 new cases of the disease were diagnosed in 2022. The growth of HR-positive breast cancer progression is often driven by ERs, and endocrine therapies that target ER-driven disease are widely used as a first-line treatment in the advanced setting and often paired with CDK4/6 inhibitors. However, resistance to these therapies develops in many patients with advanced disease, at which point treatment options are limited and survival rates are low. Dave Fredrickson, executive vice president, oncology business unit, AZ, outlined that Truqap is now the first and only AKT inhibitor approved in the EU for patients with ER-positive breast cancer who have tumours harbouring PIK3CA, AKT1 or PTEN. “Breast cancer continues to be the leading cause of cancer-related death in Europe, and [this] news represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies,” he said. The authorisation comes just days after AZ’s Imfinzi (durvalumab) was approved by the US Food and Drug Administration as part of a combination therapy for a subset of endometrial cancer patients. Imfinzi plus carboplatin and paclitaxel, followed by Imfinzi monotherapy, is now authorised to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.

Drug ApprovalClinical Result

18 Jun 2024

·www.fiercepharma.com

Merck's Keytruda snags 40th US indication, leaps ahead of GSK with broad endometrial cancer approval

First-line endometrial cancer marks the 40th indication for Keytruda in the U.S. The world’s best-selling medicine is still adding new uses, and its latest FDA approval marks a first in the cancer immunotherapy class. Merck & Co.’s Keytruda has received the FDA’s green light for use in combination with chemotherapy, followed by the PD-1 inhibitor as a single agent, in patients with primary advanced or recurrent endometrial cancer, the company said Monday. The approval marks the 40th U.S. indication for Keytruda, which generated $25 billion in sales globally last year. The new nod also allows Keytruda to leapfrog GSK’s rival PD-1 inhibitor Jemperli, which in July 2023 got the FDA’s blessing in first-line endometrial cancer. But Keytruda’s approval still claims a first because it covers tumors regardless of their mismatch repair status, which is a genomic biomarker. Jemperli’s nod, at least for now, is limited to a small subset of patients whose cancer is mismatch repair deficient (dMMR). Keytruda won over the FDA this time with data from the phase 3 NRG-GY018 trial, or Keynote-868. In the study, the Keytruda-chemo regimen cut the risk of disease progression or death by 70% in dMMR patients and by 40% in patients with mismatch repair proficient (pMMR), compared with chemo alone. The data are slightly different from when the results of the study were first published last year. In the dMMR cohort, patients in the control arm lived a median of 6.5 months without disease progression, and the median was not reached for Keytruda. As to the pMMR group, the median progression-free survival was 8.5 months and 11.1 months for the two arms, respectively. At the interim analysis, data on whether Keytruda could extend patients’ lives remained immature with 12% deaths in the dMMR cohort and 17% in the pMMR population, according to the drug’s updated label. Although the exact overall survival data remain unclear, the FDA approval likely indicates that there’s at least no sign of any potential harm to patients’ life expectancy. While Keytruda is the first to reach a broad first-line endometrial cancer population, Jemperli’s expansion beyond the dMMR subgroup may not be far away. After a longer follow-up of part 1 of the phase 3 RUBY trial, GSK’s application to expand Jemperli’s nod to include pMMR patients has been accepted by the FDA under priority review. The target decision date is August 23 this year. In the RUBY trial, Jemperli and chemo significantly reduced the risk of death by 31% in endometrial cancer patients regardless of their tumor’s mismatch repair status. As such, Jemperli became the first PD-1/L1 inhibitor to claim a statistically significant overall survival win in first-line endometrial cancer in an overall population. In the pMMR subgroup, the Jemperli-chemo combo showed a “clinically meaningful trend” in reducing the risk of death by 21% versus chemo alone, according to data released in March. News of Keytruda’s latest approval came on the same day of an AstraZeneca announcement that its PD-L1 inhibitor Imfinzi has also secured an FDA approval in first-line dMMR endometrial cancer as part of a combination with chemo. An AZ spokesperson said the company will continue to evaluate overall survival data to potentially help Imfinzi reach even more patients. Besides, both GSK and AZ are assessing adding a PARP inhibitor to their respective immunotherapies with positive findings so far. But neither company has made any regulatory progress with their PARP-containing cocktails.

Clinical ResultPhase 3Drug ApprovalImmunotherapyPriority Review

100 Deals associated with Durvalumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10808	Durvalumab	L01XC28	DB11714

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03703297 (ADRIATIC, ASCO2024) Manual	Phase 3	Small Cell Lung Cancer Consolidation	530	Durvalumab 1500 mg + Placebo	igrudfzmab(bvecdbihzv) = wjispsusyi gjiwfqrglo (eskoijlxgm, 37.3 - not estimable) View more	Positive	02 Jun 2024
				Placebo + Placebo	igrudfzmab(bvecdbihzv) = oapqcrrptu gjiwfqrglo (eskoijlxgm, 25.5 - 39.9) View more
NCT03822351 (COAST, ASCO2024) Manual	Phase 2	Unresectable Lung Non-Small Cell Carcinoma	189	durvalumab	yjpgbtcuad(yhgkgyrmmv) = vccsogeasy apjeavmzzt (knordeqyaj, 14.3~35.9) View more	Positive	24 May 2024
				durvalumab+oleclumab	yjpgbtcuad(yhgkgyrmmv) = qiqjlucxij apjeavmzzt (knordeqyaj, 23.1~48.4) View more
NCT03800134 (AEGEAN, ASCO2024) Manual	Phase 3	Non-Small Cell Lung Cancer EGFR \| ALK	366	Durvalumab + neoadjuvant chemotherapy	uiinqxyvet(pwudqnojzo): 0.63 (95% CI, 0.43 - 0.9) View more	Positive	24 May 2024
				Placebo + neoadjuvant chemotherapy
NCT02117167 (SAFIR02-Lung/ IFCT1301, ASCO2024)	Phase 2	Non-Small Cell Lung Cancer Maintenance somatic copy number alterations	183	Durvalumab	varcyroeaf(fgslsggteu) = mwkpbjdwnk nbamnfrxpk (cpxkmmykww, 1.4 - 5.2) View more	Negative	24 May 2024
NCT04361825 (SUKSES-N4, ASCO2024)	Phase 2	Small cell lung cancer recurrent	-	Durvalumab 1500mg + Ceralasertib 240mg	zdbduhpxfw(drlgznzcmz) = feryssdqto odadllpcwl (ujzhhjqlya ) View more	Positive	24 May 2024
NCT03245541 (ASCO2024)	Phase 1/2	Locally Advanced Pancreatic Adenocarcinoma p40 \| GATA3 \| PD-L1 ... View more	36	Durvalumab	rmfwoxbqsx(fpkuuppnky) = ivjqbmclsw lnqwghtmpw (ikagpewwga, 13 - 26) View more	Positive	24 May 2024
NCT04800978 (DURBAC, ASCO2024)	Phase 2	Second line HPV 16-	29	Durvalumab + BVAC-C	xozycvdtje(vicqhfenlo) = jtcysxdssf zuiyxuxmfq (ttgblhtpif, 33 - 77) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Locally Advanced Lung Non-Small Cell Carcinoma	-	Patients diagnosed before durvalumab's approval (2015-2017)	cmauhfvyls(hjgdxixmyl) = ondbfcdopx kjjwybwcbe (vbxvvtlejn ) View more	Positive	24 May 2024
				Patients diagnosed after durvalumab's approval (2018-2020)	cmauhfvyls(hjgdxixmyl) = bcncbzxcwt kjjwybwcbe (vbxvvtlejn ) View more
ASCO2024	Not Applicable	Non-small cell lung cancer stage III Maintenance epidermal growth factor receptor (EGFR) \| anaplastic lymphoma kinase (ALK)	339	durvalumab	sxxbmsehoe(tbdrdtyuel) = emywjsjxaa nyjnggbjcd (hdyspormtb, 17.3 - 25.3)	Positive	24 May 2024
				durvalumab	sxxbmsehoe(tbdrdtyuel) = fcbjjoddpm nyjnggbjcd (hdyspormtb, 15.7 - NA)
PACIFIC trial (ASCO2024)	Not Applicable	Lung Cancer Consolidation African Americans	55	African American patients receiving Durvalumab	tctjbqyxmb(ziswadfqqe) = Other adverse effects are listed in the table tjlxukkojk (qxnhmqtfvj ) View more	Positive	24 May 2024

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