[Translation] A randomized, open-label, multicenter, phase III study comparing zilovertamab vedotin (MK-2140) plus R-CHP versus R-CHOP in subjects with previously untreated diffuse large B-cell lymphoma (DLBCL) (waveLINE-010)

与R-CHOP相比， zilovertamab vedotin + R-CHP的有效性、安全性和患者报告的结局指标。

[Translation]

Efficacy, safety, and patient-reported outcomes of zilovertamab vedotin + R-CHP compared with R-CHOP.

Start Date04 Mar 2025

Sponsor / Collaborator

MSD R&D (China) Co. Ltd.

NCT06858553

/ Not yet recruitingNot ApplicableIIT

A Prospective, Multi-center Study to Characterize Intestinal Fibrosis in Patients With Crohn's Disease (CD) Using MR Enterography (MRE)-Based Artificial Intelligence

Intestinal fibrotic strictures represent a severe complication of Crohn's disease (CD), affecting over half of the patients. Despite the continuous emergence of novel medications, effective treatment options remain scarce. Endoscopy fails to identify the full-thickness fibrosis of the bowel wall, and standardized assessment for cross-sectional imaging has yet to be established. Previous studies have demonstrated that radiomics models based on computed tomography and deep learning models exhibit commendable diagnostic capability. Thus, this project seeks to conduct a prospective multicenter study, with plans to recruit 234 CD patients requiring bowel resection from five medical centers. The aim is to develop and validate a deep learning model based on magnetic resonance enterography (MRE) to accurately characterize intestinal fibrosis.

Start Date01 Mar 2025

Sponsor / Collaborator

the First Affiliated Hospital of Sun Yat-Sen University

[+4]

CTR20244342

/ RecruitingPhase 2

一项在接受标准治疗的动脉性肺动脉高压（PAH）患者中，评估Sotatercept（MK-7962）按体重给药或按体重区间给药的药代动力学和安全性的II期、多中心、单盲、随机研究

[Translation] A Phase II, multicenter, single-blind, randomized study to evaluate the pharmacokinetics and safety of weight-based dosing or weight-based interval dosing of Sotatercept (MK-7962) in patients with pulmonary arterial hypertension (PAH) receiving standard therapy

主要目的：1) 评估sotatercept按体重区间给药相对于按体重给药，在稳态下多次（维持剂量）给药后的稳态全身暴露量。2) 评估sotatercept治疗24周的安全性和耐受性。次要目的：评估sotatercept按体重区间给药相对于按体重给药，在起始剂量给药后的全身暴露量。

[Translation]

Primary objectives: 1) To evaluate the steady-state systemic exposure of sotatercept after multiple (maintenance dose) administration at steady state when administered by weight intervals compared to when administered by weight. 2) To evaluate the safety and tolerability of sotatercept for 24 weeks. Secondary objectives: To evaluate the systemic exposure of sotatercept after the initial dose when administered by weight intervals compared to when administered by weight.

Start Date13 Dec 2024

Sponsor / Collaborator

MSD R&D (China) Co. Ltd.

[+2]

100 Clinical Results associated with MSD R&D (China) Co. Ltd.

0 Patents (Medical) associated with MSD R&D (China) Co. Ltd.

Literatures (Medical) associated with MSD R&D (China) Co. Ltd.

21 Apr 2025·Cancer Research

Abstract 1015: Real-world evaluation of androgen receptor (AR) ligand-binding domain (LBD) mutations in Chinese patients with metastatic castration-resistant prostate cancer (mCRPC)

Author: Xiao, Yinglong ; Li, Dapeng ; Liu, Xiaoqiao ; Pena, Carol ; Chen, Yufei ; Dong, Bingjie ; Dettman, E.J. ; Markensohn, Julia

AbstractPurpose:While AR LBD mutations have been extensively studied in Caucasian populations, there is a lack of research in Chinese populations. This study aimed to investigate the prevalence of AR LBD activated mutations in Chinese mCRPC patients using real-world databases.Methods:This observational study analyzed two databases of Chinese mCRPC patients. The Gloriousmed database included 2, 030 patients with circulating-tumor DNA (ctDNA) collected between 2016-2023 and tested using Gloriousmed’s Pushengtai (86 genes) /Qianxianan panel (693 genes), while the Geneseeq database included 91 patients with tissue and/or ctDNA collected between 2020-2022 and tested using Geneseeq Prime panel (425 genes). Activated AR LBD mutation and other prostate driver mutations were assessed in patients with novel hormonal agents (NHA) treatment information.Results:In Gloriousmed’s ctDNA database, 633 (31.2%) were NHA-naïve (not received any NHA treatment), and 1, 397 (68.8%) were NHA-treated (undergone NHA treatment before sample collection). The prevalence of AR LBD mutations in NHA-treated patients (20.5%, 287/1397) was significantly higher than that in NHA-naïve patients (15.2%, 96/633) (Fisher test P=0.004). Regarding specific activated point mutations in the AR LBD, W742C (7.74%) and W742L (6.32%) were the two most common mutations in NHA-naïve populations, and significantly higher prevalence of L702H (5.44% vs 2.37%) and T878A (9.45% vs 3.48%) mutations were found in NHA-treated patients compared to NHA-naïve patients (Fisher test P<0.01).. In Geneseeq database, 21 (23.1%) subjects were NHA-naïve, while 70 (76.9%) were NHA-treated. The prevalence of AR LBD mutations in ctDNA was numerically higher in NHA-treated (21.3%, 13/61) than in NHA-naïve patients (5%, 1/20) (Fisher test P=0.17). Notably, the prevalence of AR LBD mutations in ctDNA was significantly higher than that in tissue (14/81 vs. 3/57, Fisher test P=0.04).Conclusions:This study found consistent prevalence of AR LBD activated mutations (20.5% and 21.3%) in ctDNA from Chinese mCRPC patients after NHA treatment using two real-world datasets. Higher prevalence of AR LBD mutations was observed in NHA-treated patients compared to NHA-naïve patients and in ctDNA compared to tissue samples. Different patterns of specific AR LBD mutations were also identified in NHA-naïve and NHA-treated patients. These findings provide valuable insights into the overall prevalence of AR LBD mutations, as well as specific point mutations frequency that potentially associated with different treatment in real-world datasets of Chinese mCRPC patients.Citation Format:Yufei Chen, Bingjie Dong, Dapeng Li, Yinglong Xiao, Julia Markensohn, E.J. Dettman, Carol Pena, Xiaoqiao Liu. Real-world evaluation of androgen receptor (AR) ligand-binding domain (LBD) mutations in Chinese patients with metastatic castration-resistant prostate cancer (mCRPC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 1015.

03 Mar 2025·Cancer Discovery

Temporal Genomic Analysis of Homogeneous Tumor Models Reveals Key Regulators of Immune Evasion in Melanoma

Article

Author: Du, Peter P. ; Zerbib, Mirie ; Pai, Joy A. ; Orr, Irit ; Oren, Roni ; Schäffer, Alejandro A. ; Samuels, Yardena ; Brenner, Ori Jacob ; Fellus-Alyagor, Liat ; Golani, Ofra ; Satpathy, Ansuman T. ; Cao, Yingying ; Ranmar, Dean ; Yin, Yajie ; Yakubovich, Elizabeta ; Cheng, Kuoyuan ; Cohen Shvefel, Sapir ; Levy, Ronen ; Savchenko, Ilya ; Pal, Lipika R. ; Yao, Winnie ; Raposo, Colin J. ; Martínez Gómez, Julia M. ; Salame, Tomer M. ; Dahan, Rony ; Ketrarou, Nadav ; Levesque, Mitchell P. ; Sella, Federica ; Bartok, Osnat ; Welti, Michele ; Herzog, Ella ; Weller, Chen ; Goliand, Inna ; Gumpert, Nofar ; Hiam-Galvez, Kamir J. ; Ben-Dor, Shifra ; Ruppin, Eytan ; Zemanek, Marie J.

AbstractLow intratumor heterogeneity correlates with increased patient survival and immunotherapy response. However, even highly homogeneous tumors are variably aggressive, and the immunologic factors impacting aggressiveness remain understudied. In this study, we analyzed the mechanisms underlying immune escape in murine tumors with low intratumor heterogeneity. We used immunophenotyping and single-cell RNA sequencing to compare the temporal growth of in vivo transplanted, genetically similar, rejected and nonrejected single-cell clones. Nonrejected clones showed high infiltration of tumor-associated macrophages, lower T cell infiltration, and increased T cell exhaustion when compared with rejected clones. Comparative analysis of rejection-associated gene expression programs, combined with in vivo CRISPR knockout screens of candidate regulators, identified macrophage migration inhibitory factor (Mif) as a major contributor to preventing immune rejection. Mif knockout resulted in smaller tumors and reduced tumor-associated macrophage infiltration. These results were validated in patients with melanoma. Overall, our homogeneous tumor system can uncover factors regulating growth variability and identifies Mif as critical in aggressive melanoma.Significance:In this study, we find that Mif expression is associated with tumor growth and aggressiveness, specifically in tumors with low heterogeneity. These findings could facilitate the development of new strategies to treat patients with homogeneous, high MIF–expressing tumors that are unresponsive to immune checkpoint therapy.

01 Sep 2024·BMJ Open

Barriers and facilitators to implementing imaging-based diagnostic artificial intelligence-assisted decision-making software in hospitals in China: a qualitative study using the updated Consolidated Framework for Implementation Research

Article

Author: Liao, Xiwen ; Zhang, Jun ; Liu, Larry ; Yao, Chen ; Jin, Feifei

ObjectivesTo identify the barriers and facilitators to the successful implementation of imaging-based diagnostic artificial intelligence (AI)-assisted decision-making software in China, using the updated Consolidated Framework for Implementation Research (CFIR) as a theoretical basis to develop strategies that promote effective implementation.DesignThis qualitative study involved semistructured interviews with key stakeholders from both clinical settings and industry. Interview guide development, coding, analysis and reporting of findings were thoroughly informed by the updated CFIR.SettingFour healthcare institutions in Beijing and Shanghai and two vendors of AI-assisted decision-making software for lung nodules detection and diabetic retinopathy screening were selected based on purposive sampling.ParticipantsA total of 23 healthcare practitioners, 6 hospital informatics specialists, 4 hospital administrators and 7 vendors of the selected AI-assisted decision-making software were included in the study.ResultsWithin the 5 CFIR domains, 10 constructs were identified as barriers, 8 as facilitators and 3 as both barriers and facilitators. Major barriers included unsatisfactory clinical performance (Innovation); lack of collaborative network between primary and tertiary hospitals, lack of information security measures and certification (outer setting); suboptimal data quality, misalignment between software functions and goals of healthcare institutions (inner setting); unmet clinical needs (individuals). Key facilitators were strong empirical evidence of effectiveness, improved clinical efficiency (innovation); national guidelines related to AI, deployment of AI software in peer hospitals (outer setting); integration of AI software into existing hospital systems (inner setting) and involvement of clinicians (implementation process).ConclusionsThe study findings contributed to the ongoing exploration of AI integration in healthcare from the perspective of China, emphasising the need for a comprehensive approach considering both innovation-specific factors and the broader organisational and contextual dynamics. As China and other developing countries continue to advance in adopting AI technologies, the derived insights could further inform healthcare practitioners, industry stakeholders and policy-makers, guiding policies and practices that promote the successful implementation of imaging-based diagnostic AI-assisted decision-making software in healthcare for optimal patient care.

100 Deals associated with MSD R&D (China) Co. Ltd.

100 Translational Medicine associated with MSD R&D (China) Co. Ltd.

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Pipeline

Pipeline Snapshot as of 11 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

IND Application

IND Approval

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

NDA/BLA

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Belzutifan ( HIF-2α )	Neuroendocrine tumor of pancreas More	Approved
Clesrovimab ( RSV F protein )	Lower Respiratory Tract Infections More	NDA/BLA
Pembrolizumab ( PD-1 )	Recurrent Squamous Cell Carcinoma of the Head and Neck More	NDA/BLA
Human papillomavirus 9-valent vaccine, recombinant (Merck Sharp & Dohme)	HPV-related carcinoma More	NDA/BLA
Tucatinib ( HER2 )	HER2 Positive Colorectal Cancer More	Phase 3

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