A Phase 2, Open-Label Study of Intravenous Pevonedistat in Combination With Oral Decitabine and Cedazuridine in Adult Patients With Higher-Risk Myelodysplastic Syndromes

The main aim of the study is to see if signs and symptoms of myelodysplastic syndromes disappear when treated with pevonedistat combined with decitabine and cedazuridine.
Participants will receive an infusion of pevonedistat 3 times during a 28-day cycle. They will also take decitabine and cedazuridine tablets once a day for the first 5 days of the same cycle. A minimum of 6 28-day cycles is recommended, but participants can stop treatment at any time.
A bone marrow biopsy, bone marrow aspirates, and blood samples will be collected during the study.
Participants will attend a follow-up visit 30 days after their last dose of pevonedistat. Once treatment has ended, participants will be followed up with either monthly clinic visits or will be contacted every 3 months.

Start Date01 Oct 2021

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

JPRN-jRCT2031210181 / SuspendedPhase 2IIT

Phase II study of pevonedistat plus niraparib in patient with recurrent ovarian cancer

Start Date28 Sep 2021

Sponsor / Collaborator-

NCT04800627 / TerminatedPhase 1/2IIT

A Phase I/II Trial of Pevonedistat in Combination With Pembrolizumab in Patients With dMMR/MSI-H Cancers

This phase I/II trial identifies the side effects and best dose of pevonedistat when given together with pembrolizumab in treating mismatch repair deficiency (dMMR)/high-frequency microsatellite instability (MSI-H) solid tumor that has spread to other places in the body (metastatic) or has spread to nearby tissue or lymph nodes (locally advanced) and cannot removed by surgery (unresectable). Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pevonedistat and pembrolizumab may kill more tumor cells.

Start Date29 Mar 2021

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

100 Clinical Results associated with Pevonedistat

100 Translational Medicine associated with Pevonedistat

100 Patents (Medical) associated with Pevonedistat

486

Literatures (Medical) associated with Pevonedistat

01 Jan 2025·BRAIN RESEARCH

Decreased SREBP2 of the striatal cell relates to disrupted protein degradation in Huntington’s disease

Article

Author: Kim, Gyung Whan ; Cho, Kyoungjoo

This study delineated the intricate relation between cholesterol metabolism, protein degradation mechanisms, and the pathogenesis of Huntington's disease (HD). Through investigations using both animal models and cellular systems, we have observed significant alterations in cholesterol levels, particularly in the striatum, which is the primary lesion site in HD. Our findings indicate the dysregulation of cholesterol metabolism-related factors, such as LDLR and SREBP2, in HD, which may contribute to disease progression. Additionally, we uncovered disruptions in protein degradation pathways, including decreased neddylated proteins and dysregulated autophagy, which further exacerbated HD pathology. Moreover, our study highlighted the potential therapeutic implications of targeting these pathways. By restoring cholesterol levels and modulating protein degradation mechanisms, particularly through interventions, such as MLN4924, we observed potential improvements in cellular function, as indicated by the increased BDNF levels. These insights underscore the importance of simultaneously addressing cholesterol metabolism and protein degradation to alleviate HD pathology. Collectively, this study provides a basic understanding of the interplay between the decrease of SREBP2 and the dysfunctional protein degradation system derived from disrupted cholesterol metabolism in HD and HD cells.

01 Nov 2024·BIOCHEMICAL PHARMACOLOGY

The blockade of neddylation alleviates ventilator-induced lung injury by reducing stretch-induced damage to pulmonary epithelial cells

Article

Author: Lin, Chin-Kuo ; Lin, Chieh-Mo ; Shi, Chung-Sheng ; Chang, Shun-Fu ; Huang, Tzu-Hsiung

Ventilator-induced lung injury is a serious complication in mechanically ventilated patients. Neddylation, the post-translational modification of neural precursor cell-expressed developmentally down-regulated 8 (NEDD8) conjugation, regulates numerous biological functions. However, its involvement and therapeutic significance in ventilator-induced lung injury remains unknown. Therefore, this study aimed to examine the kinetics and contribution of activated neddylation and the impact of neddylation inhibition in mice subjected to high tidal volume (HTV) ventilation in vivo and human pulmonary alveolar epithelial cells stimulated through cyclic stretching (CS) in vitro. The neddylation and expression of ubiquitin conjugating enzyme 3 (UBA3), a NEDD8-activating enzyme (NAE) catalytic subunit, were time-dependently upregulated in HTV-ventilated mice. Additionally, the NAE inhibitor MLN4924 considerably attenuated acute lung injury induced by HTV ventilation, manifesting as reduced inflammation and oxidative stress. Furthermore, MLN4924 effectively reduced the secretion of inflammatory cytokines from Ly6C^high monocytes and neutrophils, subsequently decreasing endothelial permeability. Moreover, our study revealed an upregulation of the neddylation pathway, oxidative stress, and apoptosis during CS of alveolar epithelial cells. However, blockade of neddylation via MLN4924 or through UBA3 knockdown suppressed this upregulation. Overall, the inhibition of neddylation may alleviate HTV-induced acute lung injury by preventing CS-induced damage to alveolar epithelial cells. This indicates that the neddylation pathway plays a critical role in the progression of ventilator-induced lung injury. These findings may provide a new therapeutic target for treating ventilator-induced lung injury.

01 Oct 2024·SLAS Discovery

Combination screen in multi-cell type tumor spheroids reveals interaction between aryl hydrocarbon receptor antagonists and E1 ubiquitin-activating enzyme inhibitor

Article

Author: Dexheimer, Thomas S. ; Teicher, Beverly A. ; Morris, Joel ; Jones, Eric ; Coussens, Nathan P. ; Teicher, Beverly A ; Dexheimer, Thomas S ; Fang, Jianwen ; Moscow, Jeffrey A ; Doroshow, James H. ; Doroshow, James H ; Silvers, Thomas ; Coussens, Nathan P ; Jones, Eric M ; Chen, Li ; Moscow, Jeffrey A.

The aryl hydrocarbon receptor (AhR) is a ligand-activated transcription factor that regulates genes of drug transporters and metabolic enzymes to detoxify small molecule xenobiotics. It has a complex role in cancer biology, influencing both the progression and suppression of tumors by modulating malignant properties of tumor cells and anti-tumor immunity, depending on the specific tumor type and developmental stage. This has led to the discovery and development of selective AhR modulators, including BAY 2416964 which is currently in clinical trials. To identify small molecule anticancer agents that might be combined with AhR antagonists for cancer therapy, a high-throughput combination screen was performed using multi-cell type tumor spheroids grown from malignant cells, endothelial cells, and mesenchymal stem cells. The AhR selective antagonists BAY 2416964, GNF351, and CH-223191 were tested individually and in combination with twenty-five small molecule anticancer agents. As single agents, BAY 2416964 and CH-223191 showed minimal activity, whereas GNF351 reduced the viability of some spheroid models at concentrations greater than 1 µM. The activity of most combinations aligned well with the single agent activity of the combined agent, without apparent contributions from the AhR antagonist. All three AhR antagonists sensitized tumor spheroids to TAK-243, an E1 ubiquitin-activating enzyme inhibitor. These combinations were active in spheroids containing bladder, breast, ovary, kidney, pancreas, colon, and lung tumor cell lines. The AhR antagonists also potentiated pevonedistat, a selective inhibitor of the NEDD8-activating enzyme E1 regulatory subunit, in several tumor spheroid models. In contrast, the AhR antagonists did not enhance the cytotoxicity of the proteasome inhibitor bortezomib.

News (Medical) associated with Pevonedistat

30 Jan 2023

·www.prnewswire.com

Acute Myeloid Leukemia Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 200+ Companies Working in the Domain

The incidence of AML has gradually increased around the globe. Males and older people had a higher possibility to develop AML. Developed countries tended to have higher age-standardized incidence rates and death rates than developing regions. Novel therapies for AML, including refinements of conventional cytotoxic chemotherapies, genetic and epigenetic targeted drugs, as well as immunotherapies, have significantly improved patient outcomes in recent years. LAS VEGAS, Jan. 30, 2023 /PRNewswire/ -- DelveInsight's ' Acute Myeloid Leukemia Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline acute myeloid leukemia therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the acute myeloid leukemia pipeline domain. Key Takeaways from the Acute Myeloid Leukemia Pipeline Report DelveInsight's acute myeloid leukemia pipeline report depicts a robust space with 200+ active players working to develop 260+ pipeline therapies for acute myeloid leukemia treatment. Key acute myeloid leukemia companies such as GlycoMimetics, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Takeda Oncology, Orca Bio, Gilead Sciences, Actinium Pharmaceuticals, Kronos Bio, Bristol-Myers Squibb, ImmunityBio, Bellicum Pharmaceuticals, Syros Pharmaceuticals, Armaceutica, Teva Pharmaceutical Industries, New Epsilon Innovation Limited, MediGene, TC Biopharm, PersonGen BioTherapeutics, Oncoceutics, Janssen Research & Development, LLC, Immune-Onc Therapeutics, Novartis, Jasper Therapeutics, Agastiya Biotech, Poseida Therapeutics, Molecular Partners, Allogene Therapeutics, and others are evaluating new acute myeloid leukemia drugs to improve the treatment landscape. Promising acute myeloid leukemia pipeline therapies in various stages of development include Uproleselan, SKLB1028, Pevonedistat, Orca T, Magrolimab, Iomab-B, Entospletinib, Nivolumab, ALT 803, BPX-501, TCB008, Tamibarotene, Pyronaridine, Trisenox (Arsenic Trioxide), NEI-01, MDG1011, OmnImmune, anti-FLT3 CAR-T, JNJ 63709178, IO 202, IDH 305, JSP 191, AB001, P-ckit-ALLO1, MP-0533, ALLO-316, ALL0-819, and others. In January 2023, Innate Pharma SA announced the publication in Nature Biotechnology of preclinical data showing the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123. In January 2023, the FDA granted JBI-802 orphan drug designation for patients diagnosed with small cell lung cancer (SCLC) and acute myeloid leukemia (AML), according to a press release from Jubilant Therapeutics. In January 2022, Astex Pharmaceuticals, Inc. announced that the European Commission (EC) had granted orphan-drug designation (ODD) to the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the treatment of Acute Myeloid Leukemia (AML). Request a sample and discover the recent advances in acute myeloid leukemia drug treatment @ Acute Myeloid Leukemia Pipeline Report The acute myeloid leukemia pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage acute myeloid leukemia drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the acute myeloid leukemia clinical trial landscape. Acute Myeloid Leukemia Overview Acute myeloid leukemia (AML) is the most common type of leukemia in adults, accounting for roughly 80% of all cases. Clonal expansion of immature "blast cells" in the peripheral blood and bone marrow results in ineffective erythropoiesis and bone marrow failure. There are various types of AML. Each affects a different type of blood cell. The acute myeloid leukemia symptoms you experience are determined by the type of blood cell that is affected. The common acute myeloid leukemia symptoms include tiredness, weakness, pale skin, irregular heartbeat, dizziness, and others. Many tests are used for acute myeloid leukemia diagnosis. Doctors will also perform tests to determine the subtype of AML. Chemotherapy is the primary treatment for most AML types, sometimes in conjunction with a targeted therapy drug. A stem cell transplant could follow this. Other drugs (aside from standard chemotherapy drugs) may be used to treat people with acute promyelocytic leukemia (APL). Find out more about drugs for acute myeloid leukemia @ New Acute Myeloid Leukemia Drugs A snapshot of the Acute Myeloid Leukemia Pipeline Drugs mentioned in the report: Learn more about the emerging acute myeloid leukemia pipeline therapies @ Acute Myeloid Leukemia Clinical Trials Acute Myeloid Leukemia Therapeutics Assessment The acute myeloid leukemia pipeline report proffers an integral view of acute myeloid leukemia emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Acute Myeloid Leukemia Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous Therapeutics Assessment By Molecule Type: Small molecule, Cell therapy, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Cell replacements, E-selectin inhibitors, Interleukin-15 receptor agonists, Immunologic cytotoxicity, T lymphocyte replacements, Bcr-abl tyrosine kinase inhibitors, Epidermal growth factor receptor antagonists, Fms-like tyrosine kinase 3 inhibitors, Lyn protein-tyrosine kinase inhibitors, NEDD 8 activating enzyme inhibitors Key Acute Myeloid Leukemia Companies: GlycoMimetics, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Takeda Oncology, Orca Bio, Gilead Sciences, Actinium Pharmaceuticals, Kronos Bio, Bristol-Myers Squibb, ImmunityBio, Bellicum Pharmaceuticals, Syros Pharmaceuticals, Armaceutica, Teva Pharmaceutical Industries, New Epsilon Innovation Limited, MediGene, TC Biopharm, PersonGen BioTherapeutics, Oncoceutics, Janssen Research & Development, LLC, Immune-Onc Therapeutics, Novartis, Jasper Therapeutics, Agastiya Biotech, Poseida Therapeutics, Molecular Partners, Allogene Therapeutics, and others. Key Acute Myeloid Leukemia Pipeline Therapies: Uproleselan, SKLB1028, Pevonedistat, Orca T, Magrolimab, Iomab-B, Entospletinib, Nivolumab, ALT 803, BPX-501, TCB008, Tamibarotene, Pyronaridine, Trisenox (Arsenic Trioxide), NEI-01, MDG1011, OmnImmune, anti-FLT3 CAR-T, JNJ 63709178, IO 202, IDH 305, JSP 191, AB001, P-ckit-ALLO1, MP-0533, ALLO-316, ALL0-819, and others. Dive deep into rich insights for new drugs for acute myeloid leukemia treatment; visit @ Acute Myeloid Leukemia Medications Table of Contents For further information on the acute myeloid leukemia pipeline therapeutics, reach out @ Acute Myeloid Leukemia Drug Treatment Related Reports Acute Myeloid Leukemia Market Acute Myeloid Leukemia Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key acute myeloid leukemia companies, including Takeda Oncology, Immunity Bio, Teva Pharmaceuticals, among others. Relapsed/Refractory Acute Myeloid Leukemia Epidemiology Relapsed/Refractory Acute Myeloid Leukemia Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted relapsed/refractory acute myeloid leukemia epidemiology in the 7MM. Acute Lymphocytic Leukemia Pipeline Acute Lymphocytic Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute lymphocytic leukemia companies, including AbbVie, Novartis, Jazz Pharmaceutical, among others. Chronic Lymphocytic Leukemia Pipeline Chronic Lymphocytic Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic lymphocytic leukemia companies, including Celgene, Loxo Oncology, Octapharma, among others. Chronic Myeloid Leukemia Pipeline Chronic Myeloid Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic myeloid leukemia companies, including Kartos Therapeutics, Novartis, Incyte Corporation, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Blogs Upcoming Oncology Drugs Oncology Market Outlook Future of Oncology Market Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

ImmunotherapyOrphan DrugASCO

14 Sep 2021

·www.biospace.com

Best Known for Therapeutics, Takeda Sees Growing Value in Vaccines

Tokyo-based Takeda Pharmaceutical announced that the company plans to grow its vaccines business. CEO Christophe Weber discussed this today in an interview at Reuters Events’ Pharma Japan 2021 conference. Takeda distributes Moderna’s COVID-19 vaccine in Japan but the company is better known for its cancer and gastrointestinal therapeutics than its vaccines. Vaccine production, “when established,” Weber said, “has a very long life. There is no generic of vaccines, for example. So, it’s a different type of lifecycle, but it can be a very good business if you bring innovation.” In May, the company presented long-term safety and efficacy data from its ongoing pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial for its TAK-003, a vaccine against dengue. The data has also been included in a submission to the European Medicines Agency (EMA). The data showed the vaccine provided 83.6% protection against hospitalization and 62% overall efficacy against dengue. Dengue is the fastest spreading mosquito-borne viral disease. It affects about 390 million people worldwide, with 500,000 hospitalizations. In addition to the Moderna COVID-19 vaccine, the company has a license to manufacture Novavax’s COVID-19 vaccine, which is still being evaluated in clinical trials. The Japanese government had entered a contract to acquire another 50 million Moderna doses to be delivered in 2022, as well as 150 million Novavax doses. The Novavax vaccine, TAK-019, is known outside Japan as NVX-CoV2373. As part of an earlier announcement, Takeda is developing manufacturing capabilities for TAK-109 in Japan with a goal of being distributed in early 2022. The licensing deal allows Takeda to manufacture the vaccine antigen, and Novavax is supplying the Matrix-M adjuvant to Takeda that is used in the vaccine. Takeda will handle Japanese clinical trial and regulatory submission to the Pharmaceuticals and Medical Devices Agency (PMDA) and distribute TAK-019 in Japan if it is approved by Japan’s Ministry of Health, Labour and Welfare (MHLW). In July 2021, Takeda and Frazier Healthcare Partners partnered to launch HilleVax, a biopharma company designed to develop and commercialize Takeda’s norovirus vaccine candidate. HilleVax received a license from Takeda for exclusive development and commercialization rights to the vaccine candidate, HIL-214, worldwide outside Japan, in exchange for an upfront fee, future cash milestones and royalties on net sales. Takeda will keep commercialization rights in Japan and HilleVax, will integrate some of the Japan development activities into its global development plan. Takeda also has vaccine programs for pandemic influenza and Zika. “Takeda and Frazier have a history of successfully partnering together, and we are confident in HilleVax’s capabilities to progress HIL-214, the most advanced norovirus vaccine candidate in development with the potential to address the huge global burden of norovirus-associated acute gastroenteritis,” said Rajeev Venkayya, President of the Global Vaccine Business Unit, Takeda. “This will allow Takeda to focus its efforts and resources on our dengue vaccine, which we have begun filing for licensure around the world, our pandemic programs, and our partnership with the U.S. Government to develop a Zika vaccine.” Weber was quick to note that the company has 40 clinical-stage compounds, with more than 10 in late-stage development. There was some concern when its Pevonedistat for blood cancer had poor clinical trial data. Weber said, “We don’t rely on one product in our pipeline, or two, when we have 40 in clinical stage.”

VaccineLicense out/inCollaborate

02 Sep 2021

·www.biospace.com

Takeda Blood Cancer Drug Fails in Phase III

Tomohiro Ohsumi/Getty Images Japanese biopharmaceutical firm Takeda Pharmaceutical announced Wednesday that its drug candidate for leukemia failed to meet its primary endpoint in phase III. In a statement, the company said that the Phase III PANTHER ((Pevonedistat-3001) study, which looked at the effectiveness of pevonedistat when combined with azacitidine as a first-line treatment for different types of leukemia, did not produce significant results in terms of event-free survival (EFS). The trial observed the combination for treating chronic myelomonocytic leukemia (CMML), myelodysplastic syndromes (MDS) and low-blast acute myeloid leukemia (AML). The goal was to determine whether EFS would be significantly improved with the drug combination versus the azacitidine alone. The researchers defined an "event" as either a transformation to AML or death in patients with higher-risk MDS or CMML, or death in patients who already had AML. CMML is a rare type of cancer that occurs in four out of one million people in the U.S. per year, accounting for roughly 1,100 cases annually. It starts in the blood-forming cells in the bone marrow and then invades the blood. It can affect any cell in any part of the body. Approximately nine out of 10 CMML cases occur in people aged 60 years old and over, more often in men than in women. Statistics for MDS are yet to be established in the U.S., though researchers estimate the number of cases to be at about 10,000 per year. MDS occurs when the blood-forming cells in the bone marrow become abnormal. This type of cancer is usually observed after the age of 50, and the risk increases with after that. It is most common in people who are at least 70 years old. AML accounts for around 1% of all cancer cases in the U.S., affecting 20,240 people of all ages. It is the second most common type of leukemia found in children and adults, with 31% of cases occurring in the latter. Pevonedistat is a NEDD8-activating enzyme (NAE) inhibitor that results in the death of cancer cells by halting protein homeostasis. Its safety and efficacy have yet to be established. In the Phase III PANTHER trial, data showed that pevonedistat could not achieve EFS goals, although its safety pro remained consistent with previous studies for the same combination. "While we are disappointed with this outcome, we are continuing to gain a greater understanding of the full data set and hope that findings from this Phase III study will provide information to help guide research and development for potential treatment options for these underserved patient populations," said Takeda Oncology Cell Therapy and Therapeutic Area Unit head Chris Arendt, Ph.D. Full data results from the Phase III PANTHER study will be shared at Takeda's upcoming medical congress. The company is also currently speaking to the study participants' families to ascertain the trial's potential impact on the patients. The company is coordinating with the research investigators to determine the best possible treatment plan for each patient following the trial.

Cell Therapy

100 Deals associated with Pevonedistat

External Link

KEGG	Wiki	ATC	Drug Bank
D10413	Pevonedistat	-	DB11759

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 3	US	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	CN	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	JP	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	AU	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	BE	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	BR	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	CA	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	CZ	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	FR	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	DE	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03319537 (CTgov)	Phase 1/2	Mesothelioma, Malignant	9	pevonedistat (Pevonedistat)	iwdmmjxoru(wyrgxcvzgl) = mxcylgbiwv awxjtawdkn (nuhbrfuvoz, rrigczyqdq - dsougzqhys) View more	-	23 May 2024
NCT03319537 (CTgov)	Phase 1/2	Mesothelioma, Malignant	9	cisplatin+pevonedistat+pemetrexed (Pevonedistat in Combination With Pemetrexed and Cisplatin)	kuxhkhpqrl(vtqqffywqh) = kwaxsmerak dxwbxkqxhn (hcdcznudob, qutxfrzwxw - esyeihomwv) View more	-	23 May 2024
NCT04172844 (Pubmed) Manual	Phase 1	Acute Myeloid Leukemia Second line MCL1	16	azacitidine + venetoclax + pevonedistat	eovdxzozuy(zrqktnpqfy) = vkwnafqraj ftttfsunqk (ktpqtmepbz ) View more	Positive	04 Apr 2024
NCT04266795 (pevenaza, AACR2024) Manual	Phase 2	Acute Myeloid Leukemia First line FLT3 \| IDH2 Mutation \| ASXL1 \| ... View more	120	Venetoclax + Azacitidine	yhltmutvmk(nwwplssuce) = jiythkemqw nnosgeucvc (okwnttzspk ) View more	Positive	22 Mar 2024
NCT04266795 (pevenaza, AACR2024) Manual	Phase 2		120	Venetoclax + Azacitidine + Pevonedistat	ajszjhcdiy(yzlenwjqpd) = jwyabouumx hjnpaflpzg (tdardypcrd )	Positive	22 Mar 2024
NCT03330821 (ASH2023)	Phase 1/2	Acute Myeloid Leukemia	28	Pevonedistat	rmbamdzgve(dxwtgzohkh) = msfryuxwfs plnlljodqt (jxwzowiedp ) View more	Positive	11 Dec 2023
NCT03238248 (CTgov)	Phase 2	Myeloproliferative Disorders \| Myelodysplastic Syndromes	71	Azacitidine Subcutaneous Injection or Intravenous Infusion+Pevonedistat Infusion	zflrbgnrha(gynnodvlin) = ryaqepmbti drkncalhva (kswgeocqgk, lqadhozdlv - qfphpuokzq) View more	-	21 Nov 2023
NCT02782468 (CTgov)	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	23	Pevonedistat (Single Agent Arm: Pevonedistat 25 mg/m^2)	axasavdsaq(gmhffjqvxj) = ypgopirfhs uroyhrgyvh (qrqoigimhe, mgyiwrvzmb - ysogrfezfa) View more	-	03 Nov 2023
NCT02782468 (CTgov)	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	23	Pevonedistat (Single Agent Arm: Pevonedistat 44 mg/m^2)	axasavdsaq(gmhffjqvxj) = hhrlpkabeb uroyhrgyvh (qrqoigimhe, mqqlkqbdtx - sljlghhluc) View more	-	03 Nov 2023
NCT03228186 (CTgov)	Phase 2	Advanced Lung Non-Small Cell Carcinoma	40	docetaxel+Pevonedistat	jbubbwmzrx(hkdiollegr) = yrslhmeezo irvlxhcril (pfcpndntbp, jhuwuamcui - llusjhxyke) View more	-	23 Oct 2023
NCT04266795 (PEVENAZA, CTgov)	Phase 2	Acute Myeloid Leukemia	164	Venetoclax+Azacitidine (Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2)	knwrgvafda(xgpylktqno) = rzlqiechcd uxscuehqli (wqboyskotl, zugpinrlww - evgzjvizyv) View more	-	18 Sep 2023
NCT04266795 (PEVENAZA, CTgov)	Phase 2	Acute Myeloid Leukemia	164	Venetoclax+Pevonedistat+Azacitidine (Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2)	knwrgvafda(xgpylktqno) = zkwdblhfeb uxscuehqli (wqboyskotl, zihpuuecvs - nixhgubpzn) View more	-	18 Sep 2023
NCT03772925 (ASCO2023) Manual	Phase 1	Relapsing acute myeloid leukemia \| Refractory acute myeloid leukemia \| Myelodysplastic Syndromes	18	Belinostat+Pevonedistat	cawhqdxwtw(mwwzpwtkuc) = MTD was not reached in this study. gbanhckpcf (wtxdwuaiwv ) View more	Positive	31 May 2023
NCT03228186 (ASCO2023) Manual	Phase 2	Non-Small Cell Lung Cancer	31	Docetaxel+Pevonedistat	wpjfnijupc(umwtnjoosj) = dlfariynsn jhooopygpy (eybzgbljso, 8.6 - 42.3) View more	Positive	26 May 2023

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis