Delving into the Latest Updates on Merck Serono Ltd. with Synapse

概览

疾病领域	数量

肿瘤	1
免疫系统疾病	1
血液及淋巴系统疾病	1
神经系统疾病	1

排名前五的药物类型	数量

小分子化药	1

排名前五的靶点	数量

RNRs(核糖核苷酸还原酶复合体)	1

关联

1

项与 Merck Serono Ltd. 相关的药物

Cladribine

克拉屈滨

靶点

RNRs

作用机制

RNR抑制剂

在研机构

BioNxt Solutions, Inc. [+9]

原研机构

Lipomed AG

在研适应症

多发性硬化症 [+11]

非在研适应症

视神经脊髓炎

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期1993-02-26

2

项与 Merck Serono Ltd. 相关的临床试验

NCT04997148

/ CompletedN/A

Cladribine Tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice (CAMELOT-MS)

The main purpose of this study was to investigate the effectiveness of cladribine tablets in a UK real-world setting.

开始日期2021-08-11

申办/合作机构

Merck Healthcare KGaA

[+1]

NCT04695080

/ Recruiting临床2/3期

ChariotMS - A National (UK) Phase IIb, Multi-centre, Randomised, Double-blind, Placebo Controlled (1:1) Efficacy Trial With Cost-utility Analysis of Cladribine Tablets (3.5mg/kg Over Two Years) in People With Advanced Multiple Sclerosis. Is Cladribine Superior to Placebo in Protecting Upper Limb Function?

MS is a chronic inflammatory and degenerative disease of the central nervous system (CNS) affecting more than 120,000 people in the UK.and 2.5 million people worldwide.
Without disease modifying treatment (DMT),the majority of people with MS (pwMS) will develop significant disability within 10 years of onset, and 50% will require wheelchair assistance within 20 years. convenient, highly effective and CNS penetrant DMT for patients with relapsing multiple sclerosis (pwRMS) administered in short (8-10 days/year over 2 years) treatment courses.
It effectively depletes B cells, particularly Memory B cells, a likely key mechanism of disease control in MS. Cladribine is the investigational product in this study as it not currently used to treat patients with an EDSS of 6.5 - 8.5. This is a multi-centre, randomised double-blind placebo-controlled phase IIb to test cladribine tablets (MAVENCLAD®) (3.5mg/kg over 24 months) for safety, efficacy, and cost effectiveness, and to advance mechanistic understanding of its action in people with advanced MS (pwAMS).

开始日期2021-06-25

申办/合作机构

Queen Mary University of London

[+3]

100 项与 Merck Serono Ltd. 相关的临床结果

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0 项与 Merck Serono Ltd. 相关的专利（医药）

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182

项与 Merck Serono Ltd. 相关的文献（医药）

2025-04-08·Neurology

Oral Cladribine Capsules for Generalized Myasthenia Gravis: Design of the Actively Recruiting Phase 3 MyClad Study (P1-11.013)

作者: Mantegazza, Renato ; Howard, James F. ; Nolting, Axel ; Cutter, Gary ; Gopalakrishnan, Sathej ; Palace, Jacqueline ; Jack, Dominic ; Alexandri, Nektaria ; Kaminski, Henry ; O’Connor, Kevin ; Rejdak, Konrad ; Meisel, Andreas ; Dimachkie, Mazen ; Le Bolay, Claire ; Javor, Andrija

2025-04-01·Clinical and Translational Science

Effect of Cladribine Tablets on the Pharmacokinetics of a Combined Oral Contraceptive in Pre‐Menopausal Women With Relapsing Multiple Sclerosis

Article

作者: Hellwig, Kerstin ; Galazka, Andrew ; Bytyqi, Afrim ; Krebs‐Brown, Axel ; Vetter, Claudia ; Dong, Jennifer Q. ; Venkatakrishnan, Karthik ; Nolting, Axel ; Gaikwad, Sumedh ; Jack, Dominic ; Hermann, Robert

ABSTRACTThis study assessed the effect of cladribine tablets (CladT) on the pharmacokinetics (PK) of a combined oral contraceptive (COC) in pre‐menopausal women with relapsing multiple sclerosis. It was a randomized, double‐blind, two‐period, two‐sequence crossover study to assess steady‐state plasma PK (area under the concentration–time curve and peak concentration) of COC (ethinylestradiol [EE] 30 μg and levonorgestrel [LNG] 150 μg) when co‐administered with CladT or placebo. Participants received 2 weeks of active CladT treatment per course (Weeks 1 and 5 per year) to have a cumulative dose of 3.5 mg/kg over 2 years as per label. Of the 24 randomized participants, 23 completed the study. The results showed that the concentration–time profiles as well as PK parameters of EE and LNG in the plasma were similar when co‐administered with CladT or placebo. Analysis of variance confirmed the bioequivalence of EE and LNG in COC when co‐administered with either CladT or placebo. All participants were adequately exposed to cladribine. Repeat‐dose administration of CladT had no apparent effect on serum luteinizing hormone, follicle‐stimulating hormone, progesterone, or sex hormone‐binding globulin concentrations during concomitant treatment with COC. Co‐administration with COC did not change the known safety and tolerability profile of CladT and did not alter the PK of EE or LNG in a COC during the study. Therefore, the concomitant use of CladT is not expected to decrease the efficacy of COCs containing EE and LNG.Trial Registration: EudraCT Number: 2018‐001015‐70.

2025-02-10·Journal of Clinical Oncology

Avelumab in combination with axitinib (Ave + Axi) for first-line (1L) treatment of advanced renal cell carcinoma (aRCC): A systematic literature review (SLR) of real-world effectiveness and safety.

作者: Sharma, Aniket ; Elsada, Ahmed ; Taneja, Ankush ; Fontrier, Anna-Maria ; Kearney, Mairead ; Alexopoulos, Stamatia ; Roskell, Neil

491Background: Ave + Axi combination is an approved option worldwide for 1L treatment of patients with aRCC based on the results of the JAVELIN Renal 101 phase 3 trial. The results of the final analysis (data cutoff: Aug 31, 2023) confirmed the long-term efficacy and manageable safety profile of this immunotherapy (IO)/tyrosine kinase inhibitor combination with the longest follow-up (≥68 months in all patients). The aim of this SLR was to summarize the real-world effectiveness, safety, and tolerability of Ave + Axi in aRCC and compare with outcomes from JAVELIN Renal 101. Methods: A SLR was conducted using 3 online databases (MEDLINE, Embase, and Cochrane) to identify publications (to Jul 29, 2024) and recent conference abstracts of Ave + Axi real-world studies reporting outcomes for 1L treatment of aRCC, with no geographical or observational study-type restrictions. Results: A total of 9 studies met the inclusion criteria; most were retrospective (7/9), including multicenter, single-center, or database/registry studies relying on secondary data sources. Studies were conducted in the UK (4/9), Japan (3/9), USA (1/9), and Russia (1/9). Median age was 61.5-70 years; most patients were male (68%-90.5%), had an ECOG performance status of 0-1 (60%-94%), and had metastatic tumors with clear cell histology (66.7%-100%). High attrition between lines of treatment was noted, with only 35% of patients receiving second-line treatment after disease progression (most commonly with cabozantinib monotherapy, 52.2%). Median progression-free survival (PFS) ranged from 9.1-15.3 months (vs 13.9 months in JAVELIN Renal 101). Landmark 1-year PFS and overall survival rates from Ave + Axi start were 27%-68.2% and 15%-98.8%, respectively. Overall response rate was numerically higher in International Metastatic RCC Database Consortium (IMDC) risk favorable- (70.5%) vs intermediate- (64.7%) or poor-risk (39%) subgroups (reported in 1 UK study). Rates of grade ≥3 adverse events (AEs; 17%-36%) and discontinuation due to AEs (10%-27%) were low. Conclusions: Overall, findings from global real-world studies of Ave + Axi in 1L aRCC align with those of the JAVELIN Renal 101 trial, validating the long-term efficacy and safety of this combination. The high rate of attrition between lines of therapy supports the use of the most effective IO-based treatments upfront. Despite the limited number of studies and data heterogeneity, results from this SLR of real-world studies conducted in the IO era in several countries provide a good representation of Ave + Axi use in an evolving treatment landscape. Additional prospective data (eg, the ongoing multi-country AVION study; NCT04941768) and extended follow-up are required to inform the optimal use of Ave + Axi in patient subgroups, such as those with IMDC favorable-risk disease.

100 项与 Merck Serono Ltd. 相关的药物交易

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100 项与 Merck Serono Ltd. 相关的转化医学

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