An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan/5-FU/Leucovorin or Gemcitabine/Nab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients

The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints.

开始日期2025-06-01

申办/合作机构

TME Pharma NV

[+1]

NCT05093972 / Not yet recruiting临床1期

An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.

The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.

开始日期2025-04-07

申办/合作机构

Merck Sharp & Dohme Corp.

NCT06644781 / Not yet recruiting临床3期

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-containing systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).

开始日期2025-02-28

申办/合作机构

Daiichi Sankyo Co., Ltd.

[+1]

100 项与 Merck Sharp & Dohme Corp. 相关的临床结果

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0 项与 Merck Sharp & Dohme Corp. 相关的专利（医药）

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3,153

项与 Merck Sharp & Dohme Corp. 相关的文献（医药）

2025-01-01·Anesthesia and analgesia

Factors Associated With Decision to Use and Dosing of Sugammadex in Children: A Retrospective Cross-Sectional Observational Study

Article

作者: Mentz, Graciela ; Nause-Osthoff, Rebecca ; Cassidy, Ruth ; Wade, Meridith ; Brown, Sydney E.S. ; Colquhoun, Douglas A. ; Liu, Xinyue ; Zhong, Wenjun ; Kheterpal, Sachin ; DiBello, Julia

BACKGROUND::

Sugammadex was initially approved for reversal of neuromuscular blockade in adults in the United States in 2015. Limited data suggest sugammadex is widely used in pediatric anesthesia practice however the factors influencing use are not known. We explore patient, surgical, and institutional factors associated with the decision to use sugammadex versus neostigmine or no reversal, and the decision to use 2 mg/kg vs 4 mg/kg dosing.

METHODS::

Using data from the Multicenter Perioperative Outcomes Group (MPOG) database, an EHR-derived registry, we conducted a retrospective cross-sectional study. Eligible cases were performed between January 1, 2016 and December 31, 2020, for children 0 to 17 years at US hospitals. Cases involved general anesthesia with endotracheal intubation and administration of rocuronium or vecuronium. Using generalized linear mixed models with institution and anesthesiologist-specific random intercepts, we measured the importance of a variety of patient, clinician, institution, anesthetic, and surgical risk factors in the decision to use sugammadex versus neostigmine, and the decision to use a 2 mg/kg vs 4 mg/kg dose. We then used intraclass correlation statistics to evaluate the proportion of variance contributed by institution and anesthesiologist specifically.

RESULTS::

There were 97,654 eligible anesthetics across 30 institutions. Of these 47.1% received sugammadex, 43.1% received neostigmine, and 9.8% received no reversal agent. Variability in the choice to use sugammadex was attributable primarily to institution (40.4%) and attending anesthesiologist (27.1%). Factors associated with sugammadex use (compared to neostigmine) include time from first institutional use of sugammadex (odds ratio [OR], 1.08, 95% confidence interval [CI], 1.08–1.09, per month, P < .001), younger patient age groups (0–27 days OR, 2.59 [2.00–3.34], P < .001; 28 days–1 year OR, 2.72 [2.16–3.43], P < .001 vs 12–17 years), increased American Society of Anesthesiologists [ASA] physical status (ASA III: OR, 1.32 [1.23–1.42], P < .001 ASA IV OR, 1.71 [1.46–2.00], P < .001 vs ASA I), neuromuscular disease (OR, 1.14 (1.04–1.26], P = .006), cardiac surgery (OR, 1.76 [1.40–2.22], P < .001), dose of neuromuscular blockade within the hour before reversal (>2 ED95s/kg OR, 4.58 (4.14–5.07], P < .001 vs none), and shorter case duration (case duration <60 minutes OR, 2.06 [1.75–2.43], P < .001 vs >300 minutes).

CONCLUSIONS::

Variation in sugammadex use was primarily explained by institution and attending anesthesiologist. Patient factors associated with the decision to use sugammadex included younger age, higher doses of neuromuscular blocking agents, and increased medical complexity.

2024-12-31·Journal of medical economics

Cost-effectiveness of pembrolizumab for previously treated MSI-H/dMMR solid tumours in the UK

Article

作者: Mikelson, Jan ; Mantaian, Tyler ; Young, Kate ; Madin-Warburton, Matthew ; Seyla-Hammer, Carl ; Amonkar, Mayur ; Xu, Ruifeng ; Brook, Elizabeth ; Aguiar-Ibáñez, Raquel ; McCarthy, Grant ; Metcalfe, Kaylie

OBJECTIVES:

Patients with previously treated microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) tumours have limited chemotherapeutic treatment options. Pembrolizumab received approval from the EMA in 2022 for the treatment of colorectal, endometrial, gastric, small intestine, and biliary MSI-H/dMMR tumour types. This approval was supported by data from the KEYNOTE-164 and KEYNOTE-158 clinical trials. This study evaluated the cost-effectiveness of pembrolizumab compared with standard of care (SoC) for previously treated MSI-H/dMMR solid tumours in line with the approved EMA label from a UK healthcare payer perspective.

METHODS:

A multi-tumour partitioned survival model was built consisting of pre-progression, progressed disease, and dead health states. Pembrolizumab survival outcomes were extrapolated using Bayesian hierarchical models (BHMs) fitted to pooled data from KEYNOTE-164 and KEYNOTE-158. Comparator outcomes were informed by published sources. Tumour sites were modelled independently and then combined, weighted by tumour site distribution. A SoC comparator was used to formulate the overall cost-effectiveness result with pembrolizumab as the intervention. SoC comprised a weighted average of the comparators by tumour site based on market share. Drug acquisition, administration, adverse events, monitoring, subsequent treatment, end-of-life costs, and testing costs were included. Sensitivity and scenario analyses were performed, including modelling pembrolizumab efficacy using standard parametric survival models.

RESULTS:

Pembrolizumab, at list price, was associated with £129,469 in total costs, 8.30 LYs, and 3.88 QALYs across the pooled tumour sites. SoC was associated with £28,222 in total costs, 1.14 LYs, and 0.72 QALYs across the pooled tumour sites. This yields an incremental cost-effectiveness ratio (ICER) of £32,085 per QALY. Results were robust to sensitivity and scenario analyses.

CONCLUSIONS:

This model demonstrates pembrolizumab provides a valuable new alternative therapy for UK patients with MSH-H/dMMR cancer at the cost of £32,085 per QALY, with confidential discounts anticipated to improve cost-effectiveness further.

2024-12-01·ADVANCES IN THERAPY

Differences Between Intravenous and Subcutaneous Modes of Administration in Oncology from the Patient, Healthcare Provider, and Healthcare System Perspectives: A Systematic Review

Review

作者: Mittal, Lalith ; Fotheringham, Iain ; Sillah, Arthur ; Pathak, Smit ; Aguiar-Ibáñez, Raquel

BACKGROUND:

While patients with cancer have traditionally received oncology treatments through intravenous (IV) administration, some therapies are becoming available via alternative modes of administration, such as subcutaneous (SC). This study aimed to evaluate IV versus SC therapy administration from the perspectives of the patient, healthcare provider (HCP), and healthcare system.

METHODS:

A systematic review was conducted, searching MEDLINE and Embase databases from 2000 to 2022. This was supplemented with grey literature searches of additional sources such as conference proceedings. Observational studies and clinical trials were included if they assessed adult patients with any cancer type who were treated with pharmacologic therapies administered via IV or SC and included patient- or HCP-reported outcomes or healthcare system perspectives on the mode of administration. Records identified by the literature search were screened by two independent reviewers. Included studies were data extracted by a single reviewer and validated by a second reviewer and synthesized using a narrative approach.

RESULTS:

After screening, 33 unique studies were included in the systematic review. Patients and HCPs reported substantially more favorable preference rates for SC over IV treatment. Additionally, from the patient perspective there were reductions in treatment time and economic burden for SC compared with IV therapy. From the HCP's perspective, treatment time was consistently reduced by SC compared with IV treatment administration. Although information on the impact of SC and IV treatments for oncology on healthcare systems was limited, the use of SC formulations showed consistent cost savings (direct costs) and time savings from this perspective considering various uptake scenarios compared with IV administration.

CONCLUSION:

Compared with IV administration, SC oncology treatment is a preferred option by patients and HCPs, increasing optionality and reducing treatment time while simultaneously increasing capacity and reducing the financial burden on healthcare systems.

1,254

项与 Merck Sharp & Dohme Corp. 相关的新闻（医药）

2024-12-17

·ir.vaccinex.com

Vaccinex Announces Receipt of Delisting Notification from Nasdaq

ROCHESTER, N.Y., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX) (“Vaccinex” or the “Company”), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease by blocking astrogliosis and neuroinflammation through the inhibition of SEMA4D, today announced that on December 16, 2024, the Company received written notice (the “Notice”) from the Office of General Counsel of The Nasdaq Stock Market (“Nasdaq”) indicating that the Nasdaq Hearings Panel has determined to delist the Company’s shares from Nasdaq due to the Company’s failure to meet Nasdaq’s continued listing standards. As previously disclosed, the Company has not been compliant with the requirements under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market. The Notice indicated that trading in the Company’s shares of common stock (the “Common Stock”) on Nasdaq will be suspended effective at the open of trading on Wednesday, December 18, 2024. Upon suspension of the trading of its Common Stock on Nasdaq, the Company expects that its Common Stock will be quoted under its existing symbol “VCNX” on the OTC Markets Group. About Vaccinex, Inc. Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes triggers damaging inflammation in chronic diseases of the brain and prevents infiltration and activation of immune cells in tumors. Pepinemab was studied as a monotherapy in the Phase 1b/2 SIGNAL-AD study in Alzheimer’s Disease, and the Company has previously published promising Phase 2 data in Huntington’s disease. Vaccinex believes pepinemab could also be an important contributor to combination therapy in AD. In oncology, pepinemab is being evaluated in combination with KEYTRUDA® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma. Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA. BAVENCIO®/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer. About Pepinemab Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton in cells and lead to loss of homeostatic functions of astrocytes and other glial cells in the brain and of dendritic cells in immune tissue. Pepinemab appears to have been well-tolerated with a favorable safety profile in multiple clinical trials in different neurological and cancer indications. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they may be forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements identified by words such as “may,” “will,” “intends,” “plans,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). These statements include, among others, those regarding the expected timing of the quotation of the Company’s Common Stock on the OTC Markets Group. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission (the “SEC”) and the other risks and uncertainties described in Vaccinex’s most recent year-end Annual Report on Form 10-K and subsequent SEC filings. Investor Contact Elizabeth Evans, PhD Chief Operating Officer, Vaccinex, Inc. (585) 766-2033 eevans@vaccinex.com Source: Vaccinex, Inc.

临床2期临床结果

2024-12-12

·药研网

安进中国总经理及另外2位高管同时离任

12月11日下午，据多方面消息证实，安进公司有重大人事变动情况发生。安进副总裁兼中国总经理许蔼龄、中国心血管事业部负责人吴海以及中国骨科业务负责人范成敏三人于同一时间宣布离任。安进亚太区总经理柯美玲以邮件形式向全体员工通报了该消息，并对这三位即将离任的高管在过往为公司所做出的贡献致以诚挚的谢意。柯美玲还着重强调，安进在中国的战略核心方向将维持稳定不变，且期望能与员工携手共渡这一变革时期，勇敢迎接转型阶段所面临的各项挑战。此次离职的许蔼龄，恰是在三年前从柯美玲手中接过安进中国区总经理的重任。许蔼龄于 2021 年 8 月 19 日正式加入安进，担任安进副总裁兼中国总经理，直接向安进副总裁兼亚太区总经理柯美玲汇报工作。在加入安进之前，许蔼龄曾在杨森、罗氏等多家跨国药企的不同区域市场中担任领导要职，并且成功引领组织完成转型，塑造出一种高度参与、协同合作且以客户为中心的卓越绩效企业文化，极大地加快了患者用药的可及性进程，有力地推动了当地医疗政策环境的构建。在过去三年多的时间里，许蔼龄带领其团队进一步对中国市场进行深度布局。与此同时，安进中国心血管事业部负责人吴海也宣告离职。加入安进之前，他是诺华中国中枢神经疾病领域负责人，在此之前，还曾任职于默沙东、辉瑞等跨国药企。在 2019 年，其在中国成功推出首款创新产品依洛尤单抗，此产品乃是国内首个获批上市的 PCSK9 抑制剂。高管范成敏则是安进中国骨健康事业部的负责人。据公开资料显示，在骨健康领域，随着安进的生物制剂普罗力（地舒单抗）于 2020 年在中国的成功上市，历经 4 年多的发展历程，安进已然成为骨质疏松症市场的先锋开拓者与引领者。安进已启动内外部招聘以尽快确定继任者人选。据悉，在尚未确定继任人选之前，柯美玲将会兼任安进中国区临时总经理一职，以负责领导中国区的业务运营工作。安进自 2012 年进入中国并在上海设立总部以来，于 2018 年将首款创新药物引入中国市场。在进入中国的 10 多年间，安进已顺利将涵盖心血管疾病、骨健康等多个关键疾病领域的 7 款创新药物引入中国，且其中有 5 款药物已被纳入医保体系。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 10月 | 20家生物医药裁员汇总 2 国产首款四价HPV疫苗拟纳入优先审评 3 3. 7亿美元!今年规模最大的生物医药融资诞生

高管变更疫苗

2024-12-12

·UmabsDB

Celldex启动KIT抗体特应性皮炎2期临床

Umabs DB作为目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用。近期，根据UmabsDB数据库的记录，Cedex在clinical trials网站上，登记了一项KIT的抗体药物Barzolvolimab（CDX-0159），在特应性皮炎患者中启动一项2期临床试验NCT06727552，该临床将于2024年12月启动，计划入组人数为120例。 Barzolvolimab是一款靶向KIT单克隆抗体，对于KIT二聚体具有高亲和力，作用机制为降低类胰蛋白酶和皮肤中肥大细胞的数量。同时采用YTE技术延长半衰期，三期临床采用每8周给药一次的维持治疗方案。今年7月，Barzolvolimab（CDX-0159）已经宣布启动两项慢性荨麻疹的三期临床试验（1800例：Celldex启动KIT抗体慢性荨麻疹两项3期临床），同时还在多种自免疾病中正在进行临床。除了Celldex，JASPER也开发了一种非偶联的、非糖基化的抗 c-Kit 抗体Briquilimab （JSP191），可在功能上阻断 c-Kit 受体与其配体干细胞因子（SCF）的相互作用。SCF 和 c-Kit 的相互作用是肥大细胞存活所必需的。通过阻断SCF与c-Kit的结合并破坏关键的存活信号，briquilimab使肥大细胞有序死亡，目前正在自发性荨麻疹中开展临床（Jasper制药启动c-Kit抗体Briquilimab在自发性荨麻疹的临床试验）。期待Barzolvolimab（CDX-0159）早日传来临床捷报，更多有关抗体的研发格局、具体信息、专利及临床等动态进展，敬请访问Umabs DB全球数据库（www.umabs.com）查阅。拓展阅读：中位OS提高10.9个月：Immutep启动LAG-3+PD-1一线非小细胞肺癌头对头三期临床试验 Macrogenics启动下一代ADAM9 ADC临床 100% CR：默沙东更新ROR1 ADC二期淋巴瘤临床数据，即将启动三期临床 MSD：收购PD-1/VEGF双抗后的回应 HIV：中裕新药将ADC拓展至抗病毒领域全球首个：默沙东ROR1 ADC启动三期临床试验 HER3终成药：HER2/HER3双抗Zenocutuzumab获FDA批准上市百利天恒两款ADC在美启动临床 3000万美元首付：GSK引进映恩一款临床前ADC药物 “四字编码”时代下的信达全梳理 BioNtech启动PD-L1/VEGF双抗肺癌两项头对头三期临床大涨68%：Janux的PSMA/CD3双抗再次取得突破疗效 316例：诺华启动BAFF-R抗体在狼疮性肾炎的三期临床 250例：默克CEACAM5 ADC开展泛癌种临床试验 AK112 vs PM8002：PD-1/VEGF第三次交锋康方生物两款PD-1双抗均进入2024年医保目录 234例：安领科启动EGFR/c-Met双抗ADC临床科伦博泰：本土首款Trop2 ADC获批上市罗氏TIGIT抗体一线肺癌再次失败 876例：恒瑞启动c-met ADC单药及多种药物联用临床科伦博泰首个双抗ADC启动临床阿斯利康：ADC药物的临床剂量转化策略最惨18A：北海康成市值仅为7520万港元，累计跌幅达到98.55% 2~3分钟完成给药：K药皮下制剂三期临床取得成功 ORR仅为5%：Immatics公布PRAME/CD3 TCR双抗临床数据石药启动EGFR ADC+ATM抑制剂联合治疗临床康方启动CD73/LAG3双抗临床试验宫颈癌：迈威Nectin-4 ADC启动第3项三期临床大涨53%：中国资产再次拯救美股biotech 翰森HS-20124为ROR-1 ADC药物？翰森公开SEZ6 ADC专利翰森公开CDH17 ADC专利复宏汉霖公布两款ADC药物专利 BioNtech: 2024研发日默沙东终于信了：5.88亿美元首付款引进礼新PD-1/VEGF双抗映恩公开PD-L1/B7H3双抗ADC临床前数据 Hexagon：新型ADC毒素提高渗透性：antikor开发高DAR值片段抗体ADC Genmab终止两款CD3双抗开发，重聚焦后期管线第一三共开发皮下HER2 ADC 三抗来袭：Aditum Bio以3500万美元首付款引进维立志博CD3/CD19/BCMA 强生公布膜依赖性MSLN/CD3双抗金赛公开自主开发TOPOi ADC平台礼来公布PTK7 ADC药物临床前数据双payload ADC逐步工业化，多款药物即将进入临床恒瑞SHR-A2009：国内首个HER3 ADC进入三期 ADC：抗原高表达的必要性？关于Umabs DB Umabs DB是目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用，更多信息可联系info@umabs.com

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泊沙康唑 ( fungal CYP51A1 )	侵袭性真菌感染更多	批准上市
头孢洛扎/他唑巴坦 ( PBP1b x PBP3 x β-lactamase )	医院获得性肺炎更多	批准上市
Gefapixant Citrate ( P2X3 receptor )	难治性慢性咳嗽更多	批准上市
15价肺炎球菌结合疫苗（默克）	肺炎球菌感染更多	批准上市
四价人乳头瘤病毒疫苗（酿酒酵母）	尖锐湿疣更多	批准上市