预约演示
更新于：2025-05-09
BeiGene Ltd.
更新于：2025-05-09
概览
标签
肿瘤
血液及淋巴系统疾病
免疫系统疾病
小分子化药
单克隆抗体
蛋白水解靶向嵌合体（PROTAC）
疾病领域得分
一眼洞穿机构专注的疾病领域
技术平台
公司药物应用最多的技术
靶点
公司最常开发的靶点
关联
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
最高研发阶段 |
首次获批国家/地区 |
首次获批日期 |
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
最高研发阶段 |
首次获批国家/地区 |
首次获批日期 |
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
最高研发阶段 |
首次获批国家/地区 |
首次获批日期 |
NCT06854003
A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma
NCT06849713
A Phase 2 Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT05690035
PD-1 Antibody (Tislelizumab) Combined With VEGFR 1/2/3 Inhibitor (Fruquintinib) for ARID1A-mutated Metastatic pMMR/MSS Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial
100 项与 BeiGene Ltd. 相关的临床结果
登录后查看更多信息
登录后查看更多信息
2025-05-01ADVANCES IN THERAPY
First-Line Tislelizumab Plus Chemotherapy for Esophageal Squamous Cell Carcinoma with Programmed Death-Ligand 1 Expression ≥ 1%: A Retrospective Analysis of RATIONALE-306
Article
作者: Wang, Lei ; Xu, Jianming ; Kojima, Takashi ; Wyrwicz, Lucjan ; Park, Sook Ryun ; Kato, Ken ; Kadva, Alysha ; Jimenez-Fonseca, Paula ; Yoon, Harry H ; Shi, Jingwen ; Yan, Sebastian ; Hubner, Richard ; Wu, Hongqian ; Ishihara, Ryu ; Van Cutsem, Eric
INTRODUCTION:
The United States Food and Drug Administration Oncologic Drugs Advisory Committee voted (September 2024) against the use of programmed cell death protein-1 inhibitors for first-line treatment of advanced or metastatic unresectable esophageal squamous cell carcinoma (ESCC) with a programmed death-ligand 1 (PD-L1) expression Tumor Area Positivity (TAP) score < 1% or combined positive score < 1 due to an unfavorable benefit-risk profile observed across the phase 3 CheckMate 648, KEYNOTE-590, and RATIONALE-306 trials. Therefore, we conducted a retrospective analysis of RATIONALE-306 to evaluate the efficacy and safety of tislelizumab plus investigator-chosen chemotherapy (ICC) versus placebo plus ICC in patients with advanced or metastatic unresectable ESCC and a PD-L1 TAP score ≥ 1%.
METHODS:
Adult patients with advanced or metastatic unresectable ESCC enrolled in the global, randomized, phase 3 RATIONALE-306 trial randomly received tislelizumab 200 mg every 3 weeks plus ICC or matched placebo plus ICC. Efficacy and safety outcomes were evaluated among patients who were retrospectively assessed for PD-L1 expression defined by a TAP score ≥ 1%.
RESULTS:
At primary analysis data cutoff (February 28, 2022), a clinically meaningful improvement in median overall survival was observed among 230 patients in the tislelizumab plus ICC arm {16.8 [95% confidence interval (CI) 15.3-20.8] months} versus 248 patients in the placebo plus ICC arm [9.6 (95% CI 8.9-11.8) months] [stratified hazard ratio 0.64 (95% CI 0.51-0.80)]; this was maintained at a 3-year follow-up data cutoff (November 24, 2023). Similar findings at primary analysis were observed for progression-free survival, objective response rate, disease control rate, and duration of response. Tislelizumab plus ICC was tolerable and no new safety signals were observed.
CONCLUSIONS:
Tislelizumab plus ICC is an effective and well tolerated first-line treatment option for patients with advanced or metastatic unresectable ESCC and a tumor PD-L1 TAP score ≥ 1%.
TRIAL REGISTRATION NUMBER:
ClinicalTrials.gov NCT03783442.
2025-05-01ADVANCES IN THERAPY
First-Line Tislelizumab Plus Chemotherapy for Advanced Gastric Cancer with Programmed Death-Ligand 1 Expression ≥ 1%: A Retrospective Analysis of RATIONALE-305
Article
作者: Yang, Silu ; Fornaro, Lorenzo ; Rha, Sun Young ; Xu, Rui-Hua ; Yamaguchi, Kensei ; Kato, Ken ; Cruz-Correa, Marcia ; Arkenau, Tobias ; Wyrwicz, Lucjan ; Kadva, Alysha ; Moehler, Markus ; Pazo-Cid, Roberto A ; Tabernero, Josep ; Spigel, David ; Disel, Umut ; Sheng, Tao ; Xu, Yaling ; Oh, Do-Youn ; Hirano, Hidekazu ; Lee, Keun-Wook
INTRODUCTION:
Tislelizumab plus investigator-chosen chemotherapy (ICC) demonstrated a statistically significant improvement in overall survival (OS) versus placebo plus ICC in RATIONALE-305 in patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric cancer/gastroesophageal junction cancer (GC/GEJC) in the intent-to-treat population and in patients with programmed death-ligand 1 (PD-L1) Tumor Area Positivity (TAP) score ≥ 5%. The United States Food and Drug Administration Oncologic Drugs Advisory Committee voted (September 2024) against first-line treatment with programmed cell death protein-1 inhibitors in this setting in patients with a PD-L1 combined positive score < 1 or TAP score < 1%, due to an unfavorable benefit-risk profile. Thus, we retrospectively analyzed data from RATIONALE-305 in patients with a PD-L1 TAP score ≥ 1%.
METHODS:
Adult patients with locally advanced unresectable or metastatic HER2-negative GC/GEJC were randomized to tislelizumab 200 mg or placebo with ICC every 3 weeks. Efficacy and safety outcomes of tislelizumab plus ICC versus placebo plus ICC were retrospectively assessed in those with a PD-L1 TAP score ≥ 1%.
RESULTS:
At the final analysis cutoff (February 28, 2023), 432 patients received tislelizumab plus ICC and 453 received placebo plus ICC, and had a PD-L1 TAP score ≥ 1%. Clinically meaningful improvements to OS were observed with tislelizumab plus ICC compared with placebo plus ICC [15.0 months (95% confidence interval [CI] 13.3-16.7) vs. 12.8 months (95% CI 12.1-14.1), respectively; stratified hazard ratio 0.77 (95% CI 0.67-0.90)]. Progression-free survival, overall response rate, duration of response, and disease control rate, were also improved. OS improvements were maintained at a 3-year data cutoff (February 28, 2024). Tislelizumab plus ICC had an acceptable safety profile with no new safety signals.
CONCLUSIONS:
Tislelizumab plus ICC is an effective and tolerable first-line treatment for patients with locally advanced unresectable or metastatic HER2-negative GC/GEJC with a PD-L1 TAP score ≥ 1%.
TRIAL REGISTRATION NUMBER:
NCT03777657.
2025-05-01Journal of Managed Care & Specialty Pharmacy
Number needed to treat and associated cost analysis of zanubrutinib vs ibrutinib in chronic lymphocytic leukemia
Article
作者: Piran, Hossein Zivari ; Massoudi, Marjan ; Chanan-Khan, Asher ; Yang, Keri ; Balk, Mark ; Hanna, Kirollos ; Xue, Mei ; Gani, Ray
BACKGROUND:
Zanubrutinib, a Bruton tyrosine kinase inhibitor, is an approved treatment for chronic lymphocytic leukemia (CLL).
OBJECTIVE:
To compare zanubrutinib vs ibrutinib for relapsed refractory (R/R) CLL by calculating the number needed to treat (NNT) to avoid 1 progression or death and the associated cost impact.
METHODS:
An NNT analysis was conducted to estimate the number of patients with R/R CLL that need to be treated to prevent 1 progression or death. Clinical efficacy data were derived from the ALPINE trial, with 24-month progression-free survival (PFS) data from the final analysis of the ALPINE trials used for the base-case analysis. An economic analysis was conducted from a US payer perspective to assess the cost impact associated with NNT, incorporating costs of direct treatment, adverse event management, medical resources utilization, and subsequent treatment. It quantified the PFS-based NNT, the incremental cost per treated patient, and incremental cost per additional patient experiencing progression or death. Deterministic sensitivity analyses were performed to evaluate parameter uncertainties and identify key drivers. Scenario analyses explored different PFS estimates.
RESULTS:
In the base-case analysis, treating 8 patients with zanubrutinib instead of ibrutinib prevented 1 progression or death. The total costs per patient treated with zanubrutinib and ibrutinib were $399,928 and $447,059, respectively, with cost savings of $47,132 per zanubrutinib-treated patient. Drug costs and PFS are the major impact factors on the incremental cost per patient. In the scenario analyses, the NNT ranged from 8 to 12, with cost savings of $46,105-$52,860 per zanubrutinib-treated patient. In a hypothetical 100-patient clinical practice, zanubrutinib could prevent approximately 13 progression or death events.
CONCLUSIONS:
Zanubrutinib may offer more favorable clinical outcomes with cost savings compared with ibrutinib for R/R CLL treatment from a US payer perspective. Additionally, cost savings could be realized from the Enhancing Oncology Care model, a value-based payment structure that incentivizes providers to deliver high-quality care while reducing overall health care spending.
100 项与 BeiGene Ltd. 相关的药物交易
登录后查看更多信息
100 项与 BeiGene Ltd. 相关的转化医学
登录后查看更多信息
组织架构
使用我们的机构树数据加速您的研究。
登录
或
管线布局
2025年05月13日管线快照
管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期
药物发现
7
16
临床前
临床申请
1
34
临床1期
临床2期
8
11
临床3期
申请上市
2
6
批准上市
其他
29
登录后查看更多信息
当前项目
登录后查看更多信息
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
营收
使用 Synapse 探索超过 36 万个组织的财务状况。
登录
或
科研基金(NIH)
访问超过 200 万项资助和基金信息，以提升您的研究之旅。
登录
或
投资
深入了解从初创企业到成熟企业的最新公司投资动态。
登录
或
融资
发掘融资趋势以验证和推进您的投资机会。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用