A PHASE 1, RANDOMIZED, OPEN-LABEL, 4-PERIOD, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO ESTIMATE THE EFFECT OF TABLET FORMULATION ON THE RELATIVE BIOAVAILABILITY OF MEVROMETOSTAT (PF-06821497)

The purpose of the study is to compare the amount of mevrometostat available from four different tablet formulations, taken with food, in healthy adult participants.
This study is seeking male or female participants who:
* are 18 years or older
* are healthy as decided by medical tests.
* have a Body mass index (BMI) of 16 to 32 kilogram per meter squared
* a total body weight of more than 50 kilograms (110 pounds).
All participants will take part in 4 study periods to receive 4 different treatments, which are assigned in a random order. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of the next period.
Each treatment consists of a single dose of mevrometostat (PF-06821497), and the treatments differ only by tablet formulation.
How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after giving each of these tablets. The results will be used to see the effect of tablet formulation on the amount of mevrometostat (PF-06821497) available in the blood of the participants.
Participants will be in the study for about 12 weeks.

开始日期2024-12-16

申办/合作机构

Pfizer Inc.

CTR20243908 / Recruiting临床3期

一项 PF-06821497 (Mevrometostat) 联合恩扎卢胺治疗转移性去势抵抗性前列腺癌的 III 期、随机、双盲、安慰剂对照研究 (MEVPRO-2)

主要目的：证明 PF-06821497 联用恩扎卢胺在延长 rPFS 方面优于安慰剂联用恩扎卢胺。关键次要： 1. 证明 PF-06821497 联用恩扎卢胺在延长 OS 方面优于安慰剂联用恩扎卢胺。 2. 证明 PF-06821497 联用恩扎卢胺在延长 TTPP 方面优于安慰剂联用恩扎卢胺其他次要： 1.评估抗肿瘤活性 2.比较治疗组和对照组之间的安全性和耐受性 3.评估 ctDNA 负荷与临床结果之间的相关性 4.评估 PF-06821497 联合恩扎卢胺的 PK 5.比较治疗组和对照组之间的 PRO 探索性：了解所研究的治疗干预药物与研究参与者疾病生物学之间的关系。

开始日期2024-10-22

申办/合作机构

Pfizer Inc.

[+2]

NCT06629779 / Recruiting临床3期

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

开始日期2024-10-22

申办/合作机构

Pfizer Inc.

100 项与 Mevrometostat 相关的临床结果

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100 项与 Mevrometostat 相关的转化医学

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100 项与 Mevrometostat 相关的专利（医药）

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项与 Mevrometostat 相关的文献（医药）

2021-08-01·Neoplasia (New York, N.Y.)2区 · 医学

EZH2i EPZ-6438 and HDACi vorinostat synergize with ONC201/TIC10 to activate integrated stress response, DR5, reduce H3K27 methylation, ClpX and promote apoptosis of multiple tumor types including DIPG

2区 · 医学

ArticleOA

作者: Borsuk, Robyn ; Tapinos, Nikos ; Zhou, Lanlan ; Safran, Howard ; El-Deiry, Wafik S ; Lulla, Rishi ; Zhang, Yiqun ; Seyhan, Attila A

ONC201/TIC10 activates TRAIL signaling through ATF4 and the integrated stress response (ISR). ONC201 demonstrated tumor regressions and disease stability in patients with histone H3K27M-mutated midline-glioma. H3K27M-mutation prevents H3K27-methylation on the mutated allele. EZH2 inhibitors (EZH2i) reduce H3K27 methylation and have anti-tumor effects. We hypothesized ONC201 sensitivity and tumor apoptosis may increase by reducing H3K27-methylation with EZH2i or HDACi as mimics of H3K27M-mutation. EZH2i EPZ-6438 (tazemetostat) or PF-06821497 and HDACi vorinostat were combined with ONC201 to treat multiple cancer cell lines and cell viability and histone modifications were analyzed. We observed synergistic effects towards cell viability in multiple cancers by EPZ-6438 or PF-06821497 plus ONC201 or triple therapy with vorinostat, EPZ-6438, and ONC201. EPZ-6438 and vorinostat synergized with ONC201 to enhance apoptosis. Activation of the ISR and TRAIL-DR5 were observed in cells treated with ONC201 -/+ epigenetic modulators. Knockdown of ATF4 reduced DR5 induction and apoptosis following EZH2i and ONC201 treatment of U251 glioma cells. mRNA expression of dopamine-receptors did not correlate with ONC201 sensitivity in the tumor cell lines tested (N = 12), including changes after epigenetic drugs. Dopamine did not rescue apoptosis by ONC201 in different tumor cell lines (N = 10) including 2 GBM, 3 DIPG and did not prevent DR5 activation or apoptosis. DRD2 agonist sumanirole did not protect brain tumor cells (N = 6 including 4 DIPG cell lines) from ONC201 reduction in viability. Although synergy was observed with ONC201 and vorinostat, there was no significant increase in H3K27 acetylation in cell lines including DIPG as compared to vorinostat alone, and in some cases the acetylation was less than vorinostat alone at 72 H. H3K27 methylation reduction correlated with synergy from combinations of either EPZ-6438 or vorinostat with ONC201 or triple combination. Our findings provide a rationale for combination of ONC201 and epigenetic modulators including triple therapy for in vivo and clinical testing in treatment of human malignancies including brain tumors and DIPG.

2020-05-01·The Journal of pharmacology and experimental therapeutics3区 · 医学

Translational Pharmacokinetic-Pharmacodynamic Modeling for an Orally Available Novel Inhibitor of Epigenetic Regulator Enhancer of Zeste Homolog 2

3区 · 医学

Article

作者: Sharma, Shikhar ; Yamazaki, Shinji ; Uryu, Sean ; Gukasyan, Hovhannes J ; Wang, Hui

PF06821497 has been identified as an orally available small-molecule enhancer of zeste homolog 2 inhibitor. The objectives of the present study were to characterize pharmacokinetic-pharmacodynamic-disease relationships of PF06821497 in xenograft mouse models with diffuse large B-cell lymphoma (Karpas422). An indirect-response model reasonably fit dose-dependent pharmacodynamic responses [histone H3 on lysine 27 (H3K27) me3 inhibition] with an unbound EC ₅₀ of 76 nM, whereas a signal-transduction model sufficiently fit dose-dependent disease responses (tumor growth inhibition) with an unbound tumor stasis concentration (T _sc ) of 168 nM. Thus, effective concentration for 70% of maximal effect (EC₇₀) for H3K27me3 inhibition was roughly comparable to T _sc , suggesting that 70% H3K27me3 inhibition could be required for tumor stasis. Consistently, an integrated pharmacokinetic-pharmacodynamic-disease model adequately describing tumor growth inhibition also suggested that ∼70% H3K27me3 inhibition was associated with tumor stasis. Based on these results, we would propose that an EC₇₀ estimate for H3K27me3 inhibition corresponding to tumor stasis could be considered a minimum target efficacious concentration of PF06821497 in cancer patients. SIGNIFICANCE STATEMENT: Using a mathematical modeling approach, the quantitative relationships of an orally available anticancer small-molecule enhancer of zeste homolog 2 inhibitor, PF06821497, were characterized among pharmacokinetics, pharmacodynamic biomarker inhibition, and disease responses in nonclinical xenograft models with diffuse large B-cell lymphoma. The modeling results suggest that >70% histone H3 on lysine 27 (H3K27) me3 inhibition would be required for tumor stasis (i.e., 100% tumor growth inhibition). Accordingly, we would propose that an effective concentration for 70% of maximal effect estimate for H3K27me3 inhibition could be considered a minimum target efficacious concentration of PF06821497 in cancer patients.

2018-02-08·Journal of medicinal chemistry1区 · 医学

Optimization of Orally Bioavailable Enhancer of Zeste Homolog 2 (EZH2) Inhibitors Using Ligand and Property-Based Design Strategies: Identification of Development Candidate (R)-5,8-Dichloro-7-(methoxy(oxetan-3-yl)methyl)-2-((4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl)-3,4-dihydroisoquinolin-1(2H)-one (PF-06821497)

1区 · 医学

Article

作者: Wythes, Martin ; Sutton, Scott ; Zhu, JinJiang ; Huang, Buwen ; Bingham, Patrick ; Sach, Neal ; Stewart, Albert E. ; Kania, Robert ; Ren, Shijian ; Kumpf, Robert A. ; Kung, Pei-Pei ; Sharma, Shikhar ; Hu, Wenyue ; Kephart, Susan E. ; Xin, Shuibo ; Rollins, Robert A. ; Fan, Connie ; Liu, Wei ; Maegley, Karen A. ; Zehnder, Luke ; Nguyen, Lisa ; Gukasyan, Hovhannes J. ; Zhu, Huichun ; Khamphavong, Penney ; Gajiwala, Ketan S. ; Edwards, Martin ; Uryu, Sean ; Wang, Hui ; Sherrill, John ; Brooun, Alexei ; Krivacic, Cody ; Deng, Ya-Li ; Wang, Shuiwang ; Spangler, Jillian ; Yamazaki, Shinji ; Collins, Michael ; Grantner, Rita ; Richter, Dan ; Dinh, Dac ; Verhelle, Dominique ; Kraus, Manfred

A new series of lactam-derived EZH2 inhibitors was designed via ligand-based and physicochemical-property-based strategies to address metabolic stability and thermodynamic solubility issues associated with previous lead compound 1. The new inhibitors incorporated an sp³ hybridized carbon atom at the 7-position of the lactam moiety present in lead compound 1 as a replacement for a dimethylisoxazole group. This transformation enabled optimization of the physicochemical properties and potency compared to compound 1. Analysis of relationships between calculated log D (clogD) values and in vitro metabolic stability and permeability parameters identified a clogD range that afforded an increased probability of achieving favorable ADME data in a single molecule. Compound 23a exhibited the best overlap of potency and pharmaceutical properties as well as robust tumor growth inhibition in vivo and was therefore advanced as a development candidate (PF-06821497). A crystal structure of 23a in complex with the three-protein PRC2 complex enabled understanding of the key structural features required for optimal binding.

项与 Mevrometostat 相关的新闻（医药）

2024-11-28

·PRNewswire

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma 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: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法引进/卖出临床3期疫苗细胞疗法

2024-10-19

·药渡Daily

【药渡药闻报告-创新药篇】-2024年第40期/总第161期

全球药物批准/研发动态 01 全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）全球（不含中国）共有4个新药获批上市。其中，NDA批准2个，BLA批准1个，新适应症批准1个。与上个统计周期相比，本次减少1个批准新药。 10月3日，FDA批准纳武利尤单抗（Opdivo）联合铂类双药化疗作为新辅助治疗，随后在手术后使用纳武利尤单抗单药作为辅助治疗，用于可切除（肿瘤≥4cm和/或淋巴结阳性）非小细胞肺癌（NSCLC）且无已知EGFR突变或ALK重排的成人。纳武利尤单抗组未达到中位无事件生存期，化疗组未达到18.4个月，不良反应与Nivolumab联合化疗的其他临床试验中发生的不良反应相似。推荐的纳武利尤单抗剂量为每3周360毫克（新辅助治疗）和每4周480毫克（辅助治疗）。 10月8日，卫材宣布“URECE片剂”（Dotinurad）已在泰国获得批准，用于治疗痛风和高尿酸血症者。URECE通过选择性抑制与肾脏尿酸重吸收相关的尿酸盐转运蛋白来抑制尿酸重吸收并降低血尿酸水平。已知高尿酸血症与多种疾病有关，包括泌尿系统、内分泌系统、代谢系统和心脑血管系统的疾病，以及痛风，由于生活方式和饮食偏好的变化，患者人数将进一步增加。全球（不含中国）新药批准情况（部分） 02 全球新药申报进展根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）全球（不含中国）共有6个新药申报上市。其中，NDA申报4个，BLA申报1个，细胞疗法1个。与上次统计周期相比，本次减少2个NDA/BLA申报。 10月9日，拜耳宣布FDA已受理Elinzanetant的新药申请，用于治疗与更年期相关的中度至重度血管舒缩症状，其新药申请基于三项III期研究的积极数据OASIS 1、2和3。Elinzanetant是第一个双重神经激肽-1和3受体拮抗剂，处于后期临床开发阶段，每天口服一次。 NDA/BLA申报（部分）根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）全球（不含中国）共有6个药物获监管机构特殊资格认定。其中，化学药4个，生物药2个。与上次统计周期相比，本次增加1个获监管机构特殊资格认定的药物。 10月9日，索元生物宣布DB104（Liafensine）用于难治性抑郁症（TRD）获FDA授予快速通道资格。Liafensine是三重再摄取抑制剂，可同时抑制在抑郁症中起重要作用的5-羟色胺、去甲肾上腺素和多巴胺的再摄取。今年4月，索元生物宣布ENLIGHTEN研究顺利完成并达到了主要终点及所有次要终点。DGM4阳性TRD受试者的蒙哥马利-阿斯伯格抑郁量表评分相比对照组改善了近4.4分，其安全性及耐受性表现特别优异。 10月10日，FDA授予Coherent Biopharma的注射用CBP-1008快速通道资格，用于治疗铂类耐药卵巢透明细胞癌（OCCC）。超过315名恶性实体瘤患者已被纳入CBP-1008试验，CBP-1008耐受性良好，不良事件多为轻度至中度，ORR达到31.3%，mDOR达到7.2个月。此外，CBP-1008在RP3D为0.15 mg/kg的先前1-3L治疗中显示出优异的PROC疗效。在高级别浆液性卵巢癌（HGSOC）目标人群中，ORR和DCR分别达到50.0%和85.7%。特殊资格认定情况（部分） 03 全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）全球（不含中国）新药临床研发状态更新共计33条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及免疫系统疾病等共计10个领域。其中，肿瘤领域临床进展更新居各领域之首，为12条：涉及化学药5条，生物药5条，细胞疗法2条。 10月8日，Boehringer宣布FDA已授予胰高血糖素/GLP-1受体双重激动剂Survodutide突破性疗法认定，用于治疗患有非肝硬化代谢功能障碍相关脂肪性肝炎和中度或晚期纤维化（2期或3期）的成人。Boehringer启动了两项关于Survodutide的III期研究，分别是LIVERAGE治疗MASH和中度或晚期纤维化患者的LIVERAGE-Cirrhosis。 10月9日，多域宣布其FLT3/IRAK4双靶点抑制剂HPB-092的临床研究申请获FDA批准，即将开展用于治疗急性髓性白血病（AML）的I期临床研究。在临床前研究中，其FLT3/IRAK4双靶点抑制剂HPB-092活性指标与安全性显著优于目前已获批的同靶点药物。已有数据证明抑制IRAK4活性可以治疗RNA剪切体突变的AML和骨髓增生异常综合征。全球新药研发进展详情（部分） 04 全球医药交易事件本次统计周期（2024.10.05-10.11）全球（含中国）医药交易时间共计37起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分）国内药物批准/研发动态 01 国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）国内共有8个新药获NMPA批准上市。其中，NDA批准1个，BLA批准3个，新适应症批准4个。与上次统计周期相比，本次增加5个NMPA批准新药。 10月8日，NMPA官网显示，丽珠医药注射用醋酸曲普瑞林微球的新适应症上市申请已获得批准。该产品是每月一次肌肉注射的一种促性腺激素释放激素（GnRH）激动剂，本次获批的适应症为治疗子宫内膜异位症。GnRH可显著降低血雌激素水平，强效减轻内异症相关疼痛症状，一定程度缩小内异症病灶。此款曲普瑞林微球具有起效时间长、减少用药次数等特点，可减轻患者痛苦和用药负担，提高用药耐受性和可及性。 10月11日，君实生物宣布昂戈瑞西单抗注射液（重组人源化抗PCSK9单克隆抗体注射液）的上市许可申请获得NMPA批准，用于治疗原发性高胆固醇血症（非家族性）和混合型血脂异常的成人患者。此次获批包括2种规格，分别为150mg（1ml）/支（预充式注射器）、150mg（1ml）/支（预充式自动注射器）。JS002-003研究结果显示，昂戈瑞西单抗150mg Q2W或300mg Q4W皮下注射，可显著降低LDL-C水平达60%以上，且在52周的治疗期间始终维持稳定的降幅。国内新药批准情况（部分） 02 国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）国内共有24个新药获临床默示许可，涉及34个受理号。其中，化学药6个，治疗用生物制品17个，预防用生物制品1个。与上次统计周期相比，本次增加14个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分） 03 国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）国内共有9个新药申报上市，涉及17个受理号。其中，化药4个，治疗用生物制品5个。与上个统计周期相比，本次增加9个新药申报上市受理号。国内新药申报上市情况（部分）根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）国内共有23个新药申报临床，涉及31个受理号。其中，化学药13个，治疗用生物制品8个，预防用生物制品2个。与上次统计周期相比，本次增加6个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）国内共有1个药物获NMPA特殊资格认定。其中，化学药1个。与上次统计周期相比，本次减少1个获监管机构特殊资格认定的药物。 10月13日，恒瑞医药收到国家药品监督管理局下发的《受理通知书》，公司1类创新药、EZH2抑制剂SHR2554片的药品上市许可申请获国家药监局受理，且被纳入拟优先审评品种公示，拟定适应症为：用于既往接受过至少1线系统性治疗的复发或难治外周T细胞淋巴瘤（PTCL）。SHR2554-I-101研究前期数据显示：每天2次350mg给药SHR2554安全性良好，对包括复发或难治PTCL和滤泡性淋巴瘤（FL）在内的多种淋巴瘤中显示出良好的抗肿瘤活性；II期推荐剂量下，61%的复发或难治PTCL获得缓解，预估中位PFS为11.1个月。国内监管机构特殊资格认定药物 04 国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.10.05-10.11）国内新药临床研发状态更新共计6条，涉及肿瘤、遗传和代谢疾病以及皮肤病共计3个领域。其中，化学药4条，生物药2条。与上次统计周期相比，本次增加1条国内新药临床研发状态更新。 10月9日，诺诚健华宣布其新型酪氨酸激酶2（Tyrosine Kinase 2, TYK2）抑制剂ICP-488治疗中重度斑块状银屑病II期临床研究达到主要终点。在接受治疗12周的患者中，ICP-488展示了卓越的有效性和安全性，在每日一次6毫克和9毫克两个剂量组中，PASI 75的应答率分别达到77.3%和78.6%，PASI 90的应答率分别达到36.4%和50.0%，PASI 100的应答率分别达到11.4%和11.9%，sPGA 0/1的应答率分别达到70.5%和71.4%。 10月10日，中国药物临床试验登记与信息公示平台官网近日公示，辉瑞已经启动了一项国际多中心（含中国）III期临床研究，该研究旨在评价PF-06821497联合恩扎卢胺对比恩扎卢胺或多西他赛对既往接受过醋酸阿比特龙治疗的转移性去势抵抗性前列腺癌患者的疗效和安全性。研究表明，EZH2的过表达可通过多种作用机制来促进癌症的发生和进展，包括沉默肿瘤抑制基因的表达、促进参与细胞增殖和存活的基因表达等。国内新药研发进展（部分） 05 国内新药研发领域政策法规动态国家药监局药审中心关于发布《抗肿瘤药物临床试验中SUSAR分析与处理技术指导原则》的通告（2024年第42号）为加强临床试验可疑且非预期严重不良反应（SUSAR）信息的风险评估，提升SUSAR信息的发现、识别和风险处理，药审中心组织制定了《抗肿瘤药物临床试验中SUSAR分析与处理技术指导原则》（见附件）。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。特此通告。 06 国内新药研发领域热点新闻站在十字路口上的“ADC一哥“ 如果要问中国创新药最拿得出手的是什么，ADC药物绝对拥有一战之力。2022年科伦博泰与默沙东的百亿美元合作，以及2023年百利天恒与BMS的84亿美元交易打破了中国创新药单个项目出海记录，让外界意识到中国已经成为全球ADC药物研发的中心。然而，在国产ADC大放异彩的同时，曾经的国产“ADC一哥”荣昌生物正在面临“生死抉择”，核心产品商业化加速的同时，机会与挑战共存。更多资讯，请阅读原文罗氏，挺进CVRM领域近期，罗氏在2024年医药日活动中阐述了最新药物研发进展以及未来研发的战略方向。值得注意的是，除了肿瘤、自身免疫、神经系统、眼科等传统优势业务，心血管、肾脏及代谢领域（CVRM）成为罗氏新押注的疾病领域，罗氏认为，在下一个增长周期中，CVRM将成为业绩增长的重要引擎。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“1018创新药周报”，即可下载。

上市批准申请上市临床3期临床结果

2024-10-15

·CPHI制药在线

辉瑞重磅新药启动III期临床研究，有望成为前列腺癌一线疗法EZH2抑制剂！

关注并星标CPHI制药在线近日，中国药物临床试验登记与信息公示平台官方网站予以公示，辉瑞（Pfizer）已然开启了一项国际多中心（涵盖中国）的 III期临床研究，此研究旨在评估 PF -06821497(Mevrometostat)联合恩扎卢胺相较于恩扎卢胺或者多西他赛针对既往经受过醋酸阿比特龙治疗的转移性去势抵抗性前列腺癌患者的疗效及安全性。依据公示内容，该研究计划于国际范围纳入 600 人，在我国国内纳入90人。对于此项研究，辉瑞的愿景是构建全新的一线 mCRPC 标准治疗方案，以延长患者的生存期限。 Mevrometostat乃是辉瑞研发的一款 EZH2 抑制剂，其能够阻断癌细胞中因 EZH2 过度表达所驱动的非正常基因表达，从而致使癌细胞增殖降低、诱导细胞死亡，并且抑制癌细胞的迁移与侵袭，最终实现治疗癌症的目标。在此之前辉瑞宣称，这款药物有希望成为在美国获得批准的首款用于前列腺癌的 EZH2 抑制剂。据今年 3月辉瑞在其肿瘤学创新日期间所披露的情况，到 2030 年其肿瘤学研发管线有望推出超过8 款重磅疗法，当中便包含这一EZH2抑制剂。截图来源：中国药物临床试验登记与信息公示平台官网截图来源：Clinicaltrials官网一、EZH2：癌症治疗的新靶点目前，EZH2已然跻身癌症治疗的前沿靶点队列之中。EZH2属于一种组蛋白甲基转移酶，其异常的表达与众多癌症的发展以及不良预后存在关联，像前列腺癌、乳腺癌、肺癌以及血液恶性肿瘤等均涵盖在内。有研究指出，EZH2的过度表达能够凭借多种作用机制推动癌症的产生和发展，涵盖了使肿瘤抑制基因的表达受到抑制、促使参与细胞增殖以及存活的基因进行表达等。另外，EZH2已获证实能够通过调控参与上皮-间质转化的基因表达来助推癌症转移。举例来讲，他泽司他（tazemetostat）已经获批用于部分类型血液肿瘤的治疗。与此同期，全球范围内尚有众多的EZH2抑制剂正在进行研发工作，用于诊治多种不同类别的肿瘤。 EZH2在引发GBM癌细胞侵袭、迁移和增殖以及维系其干细胞特性的过程里发挥着关键效用。组蛋白的甲基化、乙酰化、泛素化和磷酸化等修饰将DNA编排成核小体，和正常细胞的功能以及肿瘤的发生有所关联。EZH2的过表达或者突变（像是淋巴瘤里的功能获得性突变以及髓系恶性肿瘤里的功能丧失性突变）已经在诸多肿瘤中被确认，使得EZH2成为潜在的治疗目标。已经鉴别出数种调节EZH2的机制，包含miRNA、LncRNA对EZH2mRNA的调节、翻译后的修饰、转录的调控以及通过DNA结合蛋白的DNA可及性。例如，miR-124-3p表达的增高致使mTOR和AKT磷酸化水平下降，而miR-124-3p表达的降低则产生相反效果。研究成果显示，miR-124-3p通过瞄准EZH2抑制前列腺癌的增殖和侵袭进程，同时引导细胞凋亡。 lncRNA被界定为一类长度大概为200个核苷酸、不存在显著蛋白质编码能力的RNA分子。lncRNA和癌症的进展存在关联，例如细胞侵袭、迁移和血管生成以及自噬。比如，已知HOTAIR是不同类别癌症临床结局的预测因子。LnRNA HOTAIR能够作为PRC2和不同组蛋白修饰的模块化支架。研究表明，lncRNA 调节 EZH2 基因的功能和表达。EZH2 还调节参与多种致癌信号通路的几种 lncRNA 的转录。 EZH2信号通路驱动癌症进展，并有可能干扰抗肿瘤免疫反应，因此它作为癌症治疗的有效治疗靶点而受到关注。通过使用EZH2-CRISPR/Cas9，HIF-1α被表观遗传抑制，导致癌症类型的免疫抑制作用停止或减弱。研究结果表明，利用纳米颗粒递送的EZH2 siRNA可以通过下调EZH2表达有效降低肿瘤细胞的侵袭和迁移能力，并可对卵巢癌细胞和肺癌细胞产生协同治疗作用。小发夹RNA是另一种可以在癌症治疗中抑制EZH2存在的RNA干扰。例如，通过shRNA降低EZH2水平可以降低前列腺癌细胞的转移和增殖率。因此，遗传方法为在癌症治疗中靶向和调节EZH2表达提供了一种有希望的途径。EZH2 抑制剂包括 GSK2816126、Tazemetostat、Valemetostat、cPI-0209、SHR2554、MAK683 和 PF-06821497，它们可抑制其功能并恢复致癌转录因子。二、Mevpro临床研究这是一项全球性、多中心且随机的 III期研究（Mevpro-2），用以对Mevrometostat 联合恩杂鲁胺以及安慰剂联合恩杂鲁胺于 mCRPC 患者之中的疗效展开评估，此类患者在被确诊 mCRPC 之后，除了 ADT （雄激素剥夺疗法）和第一代抗雄激素药物之外，未曾接受过其他的全身抗癌治疗。这项临床研究在日本和美国开启。另外，在8 月份，辉瑞于中国、美国等众多国家首次开启了一项有关 Mevrometostat的 III 期研究（MEVPRO-1），将恩扎卢胺联合恩扎卢胺或多西他赛用于既往已接受过醋酸阿比特龙治疗的转移性去势抵抗性前列腺癌患者。对于该研究，其目的在于延长恩扎卢胺的疗效，并取代化疗。截图来源：辉瑞肿瘤创新日资料有关研究指出，EZH2对基因活性起到参与调控的作用，和前列腺癌细胞的增殖存在关联。临床前的相关数据表明，Mevrometostat 能够抑制基因调控，并且和恩扎卢胺具备协同功效。源自辉瑞公开的临床成果，Mevrometostat与恩扎卢胺联合的1 期临床呈现出良好的抗肿瘤活性。在此之中，Mevrometostat联合恩扎卢胺针对既往接受过阿比特龙治疗的 mCRPC 患者，其中位放射学无进展生存期（rPFS）达 17.1 个月，对比以往的数据（中位 rPFS 为4.8个月），获益颇为显著；Mevrometostat联合恩扎卢胺对于既往接受过恩扎卢胺治疗的mCRPC患者，其中位rPFS为 11.7 个月。另外，辉瑞在近日还开启了另外一项 3期的 MEVPRO-2研究，这项研究打算评估 mevrometostat加恩扎卢胺对于未经阿比特龙治疗的转移性去势抵抗性前列腺癌男性患者的作用。针对这一适应症的临床研究申请（IND）也已在中国获得批准，预计很快将会在中国开启。三、多款EZH2抑制剂已获批，但适应症不同据Insight 数据库透露，当下全球已有2种药物成功获批得以上市，然而获批的适应症却各不相同。第一款：益普生研发靶向EZH2 他泽司他，其于2020年率先在美国获得批准，当前已经被批准用于上皮样肉瘤、滤泡性淋巴瘤。在 2024年 7月 4日，这款药于中国提交了上市申请（JXHS2400046），其适应症为 EZH2突变呈阳性且之前接受过至少两种系统性治疗的复发或者难治性滤泡性淋巴瘤(FL)成年患者，预计会在 2025年第二季度获批。第二款：第一三共研发且靶向 EZH1/EZH2 的 Valemetostat，它在2022 年最先于日本获批上市，当前已批准用于成人 T细胞白血病-淋巴瘤、外周 T细胞淋巴瘤；在国内的研发处于批准临床的阶段。辉瑞的 Mevrometostat 在 mCRPC 适应症方面于全球的进展可谓最快，倘若一切顺利，或许会成为全球首款获批用于前列腺癌的 EZH2 抑制剂。国内的企业在 EZH2靶点上也并未落后太多，当下共有 4款国产的EZH2抑制剂迈入了临床阶段。其中恒瑞的进展最为迅速，SHR2554已经进入了III 期临床，其适应症为外周 T 细胞淋巴瘤，该临床被 CDE授予了突破性疗法认定以及特殊审批。参考资料： [1] 中国药物临床试验登记与信息公示平台官网.Retrieved Oct 8，2024.?From http://www.chinadrugtrials.org.cn/index.html [2]Oncology Innovation Day. Retrieved March 1, 2024, from https://s28.q4cdn.com/781576035/files/doc_downloads/2024/02/29/Pfizer-Oncology-Innovation-Day-Presentation_FINAL.pdf [3]ClinicalTrials官网. From?https://clinicaltrials.gov/search?term=Mevrometostat END 来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

临床3期临床结果临床成功

100 项与 Mevrometostat 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床3期	美国	Pfizer Inc.	2024-10-21
转移性去势抵抗性前列腺癌	临床3期	中国	Pfizer Inc.	2024-10-21
转移性去势抵抗性前列腺癌	临床3期	日本	Pfizer Inc.	2024-10-21
转移性去势抵抗性前列腺癌	临床3期	阿根廷	Pfizer Inc.	2024-10-21
转移性去势抵抗性前列腺癌	临床3期	澳大利亚	Pfizer Inc.	2024-10-21
转移性去势抵抗性前列腺癌	临床3期	巴西	Pfizer Inc.	2024-10-21
转移性去势抵抗性前列腺癌	临床3期	加拿大	Pfizer Inc.	2024-10-21
转移性去势抵抗性前列腺癌	临床3期	捷克	Pfizer Inc.	2024-10-21
转移性去势抵抗性前列腺癌	临床3期	法国	Pfizer Inc.	2024-10-21
转移性去势抵抗性前列腺癌	临床3期	德国	Pfizer Inc.	2024-10-21

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03460977 (ASCO2024) 人工标引	临床1/2期	去势抵抗性前列腺癌 prostate-specific antigen (PSA)	47	Mevrometostat (PF-06821497) + Enzalutamide	鑰範餘選膚選襯鑰衊遞(襯鬱網製鏇衊觸願窪繭) = 憲蓋夢餘顧壓獵願鑰顧鏇願鬱觸襯願獵齋艱壓 (壓網顧襯顧窪鬱鏇膚膚 ) 更多	积极	2024-05-24
NCT03460977 (ESMO2022) 人工标引	临床1期	滤泡性淋巴瘤 \| 小细胞肺癌 \| 去势抵抗性前列腺癌	57	PF 06821497	夢夢齋廠鹽鏇壓糧膚構(齋餘襯蓋廠顧簾蓋簾膚) = 17 pts (1 treatment-related) 積構蓋淵壓顧蓋鹹願醖 (淵廠艱製獵築鬱蓋願憲 ) 更多	积极	2022-09-10
NCT03460977 (ESMO2022) 人工标引	临床1期	滤泡性淋巴瘤 \| 小细胞肺癌 \| 去势抵抗性前列腺癌	57	PF 06821497 (FL)		积极	2022-09-10