[Translation] A Phase IIa study evaluating the efficacy, safety, tolerability, and pharmacokinetics of Tarlatamab in Chinese subjects with advanced small cell lung cancer who have received two or more lines of treatment (DeLLphi-307)

主要目的： -通过盲态独立中心审查（BICR）根据实体瘤疗效评价标准1.1版（RECIST 1.1），评估的客观缓解率（ORR）评价Tarlatamab的有效性次要目的： -通过BICR根据RECIST 1.1评估的DOR、DC和PFS，评价Tarlatamab的有效性 -通过研究者根据RECIST 1.1评估的ORR、DOR、DC和PFS，评价Tarlatamab的有效性 -通过总生存期（OS）评价Tarlatamab的有效性 -评价安全性和耐受性 -表征Tarlatamab的药代动力学 -评价Tarlatamab的免疫原性

[Translation]

Primary Objectives: - To evaluate the efficacy of Tarlatamab by objective response rate (ORR) assessed by blinded independent central review (BICR) according to RECIST 1.1 Secondary Objectives: - To evaluate the efficacy of Tarlatamab by DOR, DC and PFS assessed by BICR according to RECIST 1.1 - To evaluate the efficacy of Tarlatamab by ORR, DOR, DC and PFS assessed by investigators according to RECIST 1.1 - To evaluate the efficacy of Tarlatamab by overall survival (OS) - To evaluate safety and tolerability - To characterize the pharmacokinetics of Tarlatamab - To evaluate the immunogenicity of Tarlatamab

Start Date07 Aug 2024

Sponsor / Collaborator

Amgen, Inc.

[+1]

CTR20241523 / RecruitingPhase 3

一项在铂类药物、依托泊苷和度伐利尤单抗治疗后广泛期小细胞肺癌受试者中比较Tarlatamab 联合度伐利尤单抗与度伐利尤单抗单药治疗的开放性、多中心、随机、3 期研究（DeLLphi-305）

[Translation] An open-label, multicenter, randomized, phase 3 study comparing tarlatamab plus durvalumab versus durvalumab alone in subjects with extensive-stage small cell lung cancer after treatment with platinum-based therapy, etoposide, and durvalumab (DeLLphi-305)

这是一项在完成铂类药物化疗（研究者所选治疗：卡铂或顺铂）、依托泊苷和度伐利尤单抗一线治疗后根据RECIST 1.1 确定持续缓解或疾病稳定的ES-SCLC 受试者中评价tarlatamab +度伐利尤单抗与度伐利尤单抗单药治疗相比的有效性和安全性的随机、开放性、多中心3 期研究。

[Translation]

This was a randomized, open-label, multicenter, phase 3 study evaluating the efficacy and safety of tarlatamab plus durvalumab compared with durvalumab alone in subjects with ES-SCLC who had a sustained response or stable disease according to RECIST 1.1 after completing first-line treatment with platinum-based chemotherapy (investigator's choice of treatment: carboplatin or cisplatin), etoposide, and durvalumab.

Start Date03 Jun 2024

Sponsor / Collaborator

Amgen, Inc.

[+1]

CTR20234106 / RecruitingPhase 1

一项评价AMG 509用于转移性去势抵抗性前列腺癌受试者的安全性、耐受性、药代动力学和有效性的1期研究

[Translation] A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects with Metastatic Castration-Resistant Prostate Cancer

在成人受试者中评价AMG 509 治疗的安全性和耐受性，确定AMG 509 治疗的最大耐受剂量（MTD）或2期推荐剂量（RP2D），表征AMG 509 治疗的药代动力学（PK）特征，初步评价AMG 509 治疗的抗肿瘤活性。

[Translation]

To evaluate the safety and tolerability of AMG 509 treatment in adult subjects, determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 509 treatment, characterize the pharmacokinetic (PK) characteristics of AMG 509 treatment, and preliminarily evaluate the anti-tumor activity of AMG 509 treatment.

Start Date20 May 2024

Sponsor / Collaborator

Amgen, Inc.

[+1]

100 Clinical Results associated with BeiGene (Beijing) Co. Ltd.

0 Patents (Medical) associated with BeiGene (Beijing) Co. Ltd.

209

Literatures (Medical) associated with BeiGene (Beijing) Co. Ltd.

01 Sep 2024·Cancer Cell

Circulating tumor DNA-based stratification strategy for chemotherapy plus PD-1 inhibitor in advanced non-small-cell lung cancer

Article

Author: Gu, Wei ; Zhang, Zhihong ; Liu, Hu ; Cui, Jiuwei ; Wang, Xiuwen ; Yu, Zhuang ; Zhang, Xiaodong ; Lv, Dongqing ; Wu, Jingxun ; Yu, Jianjun ; Hu, Sheng ; Wang, Xicheng ; Han, Liang ; Zhu, Bo ; Wang, Buhai ; Yao, Yu ; Duan, Jianchun ; Wang, Ziping ; Xu, Jiachen ; Wang, Zhijie ; Zhao, Hui ; Ji, Youxin ; Zhong, Diansheng ; Cheng, Ying ; Huang, Cheng ; Li, Xingya ; Liu, Yunpeng ; Jin, Shi ; Shen, Runxi ; Wan, Rui ; Jia, Yuming ; Yang, Zhenzhou ; Zhu, Xiaoli ; Han, Baohui ; Guo, Qisen ; Cai, Yiran ; Sun, Guogui ; Liu, An-Wen ; Nie, Lei ; Song, Yong ; Li, Baolan ; Yao, Sheng ; Feng, Jian ; Han, Zhigang ; Wang, Dong ; Yang, Jun ; Yu, Yan ; Fan, Yun ; Huang, Jianjin ; Ji, Mei ; Zhou, Shaozhang ; Wu, Xiaohong ; Shi, Meiqi ; Zhang, Wei ; Zhou, Tong ; Gao, Beili ; Shi, Jianhua ; Cai, Shangli ; Wang, Qiming ; Zhou, Caicun ; Li, Xiaoling ; Yang, Xinmei ; Wang, Jie ; Shu, Yongqian ; He, Mei ; Wu, Lin ; Miao, Liyun ; Li, Qiang ; Wang, Yingyi

Stratification strategies for chemotherapy plus PD-1 inhibitors in advanced non-small-cell lung cancer (NSCLC) are critically demanded. We performed high-throughput panel-based deep next-generation sequencing and low-pass whole genome sequencing on prospectively collected circulating tumor DNA (ctDNA) specimens from 460 patients in the phase 3 CHOICE-01 study at different time points. We identified predictive markers for chemotherapy plus PD-1 inhibitor, including ctDNA status and genomic features such as blood-based tumor mutational burden, intratumor heterogeneity, and chromosomal instability. Furthermore, we established an integrated ctDNA-based stratification strategy, blood-based genomic immune subtypes (bGIS) scheme, to distinguish patients who benefit from the addition of PD-1 inhibitor to first-line chemotherapy. Moreover, we demonstrated potential applications for the dynamic monitoring of ctDNA. Overall, we proposed a potential therapeutic algorithm based on the ctDNA-based stratification strategy, shedding light on the individualized management of immune-chemotherapies for patients with advanced NSCLC.

02 Jul 2024·Leukemia & Lymphoma

Zanubrutinib is effective in non-germinal-center B-cell-like diffuse large B-cell lymphoma with mutated CD79B , high TCL1A expression, or over- expressed MYC/BCL-2

Article

Author: Xun, Xiaolei ; Wu, Xikun ; Shen, Zhirong ; Fu, Lina ; Ma, Xiaopeng ; Yu, Yiling ; Hou, Xinfeng ; Liu, Yang ; Jin, Wei

To evaluate the effects of gene mutations on Bruton tyrosine kinase inhibitor, zanubrutinib's effectiveness in patients with diffuse large B-cell lymphoma (DLBCL), we examined pooled data from four single-arm studies (BGB-3111-AU-003 [NCT02343120], BGB-3111-207 [NCT03145064], BGB-3111_GA101_Study_001 [NCT02569476], BGB-3111-213 [NCT03520920]; n = 121). Objective response rate (ORR) was higher, though not statistically significant, in patients with activated B-cell-like (ABC)- and unclassified DLBCL (42.9% [21/49]) versus those with germinal-center B-cell-like DLBCL (14.3% [1/7]; p = 0.15). Patients with CD79B mutations had better ORR (60%) versus patients with wild-type alleles (25.9%, p < 0.01). Higher TCL1A expression correlated with better zanubrutinib response (p = 0.03), longer progression-free survival (p = 0.01), and longer overall survival (p = 0.12). TCL1A expression was higher in ABC-DLBCL (p < 0.001) and MYD88/CD79B-mutated subtypes (p < 0.0001). Eighteen patients with high MYC/BCL-2 expression responded better to zanubrutinib (ORR = 61 vs. 29%, p = 0.02). Our results support assessing CD79B mutations, co-expressor DLBCL, and TCL1A expression status to identify patients with DLBCL who will benefit from zanubrutinib.

30 Jun 2024·Chinese journal of cancer research = Chung-kuo yen cheng yen chiu

Tislelizumab in previously treated, locally advanced unresectable/metastatic microsatellite instability-high/mismatch repair-deficient solid tumors.

Article

Author: Liu, Tianshu ; Ying, Jieer ; Deng, Yanhong ; Jiang, Haiping ; Pan, Yueyin ; Wang, Jin ; Huang, Yi ; Wang, Jing ; Hu, Han ; Qian, Xiaoping ; Xu, Jianming ; Shen, Lin ; Shi, Mengyue ; Hu, Sheng ; Wang, Ke ; Wang, Dong ; Li, Jian ; Zhang, Yanqiao ; Xu, Ye ; Gao, Yunong ; Shi, Chunmei ; Yuan, Ying ; Zang, Aimin ; Gao, Quanli ; Cheng, Ying

ObjectiveThe open-label, phase II RATIONALE-209 study evaluated tislelizumab (anti-programmed cell death protein 1 antibody) as a tissue-agnostic monotherapy for microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) tumors.MethodsAdults with previously treated, locally advanced unresectable or metastatic MSI-H/dMMR solid tumors were enrolled. Patients received tislelizumab 200 mg intravenously every 3 weeks. Objective response rate (ORR; primary endpoint), duration of response (DoR), and progression-free survival (PFS) were assessed by independent review committee (Response Evaluation Criteria in Solid Tumors v1.1).ResultsEighty patients were enrolled and treated; 75 (93.8%) patients had measurable disease at baseline. Most had metastatic disease and received at least one prior therapy for advanced/metastatic disease (n=79; 98.8%). At primary analysis (data cutoff July 8, 2021; median follow-up 15.2 months), overall ORR [46.7%; 95% confidence interval (95% CI), 35.1-58.6; one-sided P<0.0001] and ORR across tumor-specific subgroups [colorectal (n=46): 39.1% (95% CI, 25.1-54.6); gastric/gastroesophageal junction (n=9): 55.6% (95% CI, 21.2-86.3); others (n=20): 60.0% (95% CI, 36.1-80.9)] were significantly greater with tislelizumab vs. a prespecified historical control ORR of 10%; five (6.7%) patients had complete responses. Median DoR, PFS, and overall survival were not reached with long-term follow-up (data cutoff December 5, 2022; median follow-up 28.9 months). Tislelizumab was well tolerated with no unexpected safety signals. Treatment-related adverse events (TRAEs) of grade ≥3 occurred in 53.8% of patients; 7.5% of patients discontinued treatment due to TRAEs.ConclusionsTislelizumab demonstrated a significant ORR improvement in patients with previously treated, locally advanced unresectable or metastatic MSI-H/dMMR tumors and was generally well tolerated.

100 Deals associated with BeiGene (Beijing) Co. Ltd.

100 Translational Medicine associated with BeiGene (Beijing) Co. Ltd.

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Pipeline

Pipeline Snapshot as of 05 Nov 2024

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

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Drug(Targets)	Indications	Global Highest Phase

Albumin-Bound Paclitaxel ( Tubulin )	Squamous non-small cell lung cancer More	Phase 3
Zanidatamab ( HER2 )	stomach adenocarcinoma More	Phase 3
Pamiparib ( PARP1 x PARP2 )	Recurrent ovarian cancer More	Phase 3
TARLATAMAB-DLLE ( CD3 x DLL3 )	Extensive stage Small Cell Lung Cancer More	Phase 3
Blinatumomab ( CD19 x CD3 )	Pre B-cell acute lymphoblastic leukemia More	Phase 2

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