[Translation] A phase 1/2 dose-escalation and expansion study of BGB-10188, a phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor, in combination with zanubrutinib in patients with mature B-cell malignancies and with tislelizumab in patients with solid tumors.

1. 确定BGB-10188单药或联合泽布替尼治疗成熟B细胞恶性肿瘤患者的最大耐受剂量（MTD），2期推荐剂量（RP2D），安全性和耐受性；BGB-10188联合替雷利珠单抗治疗晚期实体瘤患者的MTD, RP2D，安全性和耐受性； 2. BGB-10188单药或联合泽布替尼治疗复发/难治性（R/R），成熟B细胞恶性肿瘤患者及BGB-10188联合替雷利珠单抗治疗晚期实体瘤患者的初步抗肿瘤活性。

[Translation]

1. To determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety and tolerability of BGB-10188 alone or in combination with zanubrutinib in patients with mature B-cell malignancies; and the MTD, RP2D, safety and tolerability of BGB-10188 combined with tislelizumab in patients with advanced solid tumors. 2. To determine the preliminary antitumor activity of BGB-10188 alone or in combination with zanubrutinib in patients with relapsed/refractory (R/R) mature B-cell malignancies and BGB-10188 combined with tislelizumab in patients with advanced solid tumors.

Start Date23 Jun 2022

Sponsor / Collaborator

BeiGene (Shanghai) Co. Ltd.

CTR20212727 / RecruitingPhase 3

一项在患有不可切除的局部晚期或转移性HER2 阳性胃食管腺癌（GEA）的受试者中评估Zanidatamab 联合化疗，联合或不联合替雷利珠单抗疗效的随机、多中心、III 期研究

[Translation] A randomized, multicenter, phase III study evaluating zanidatamab in combination with chemotherapy, with or without tislelizumab, in subjects with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA)

主要目的：在不可切除的局部晚期、复发或转移性HER2阳性GEA受试者中比较Zanidatamab联合化疗，联合或不联合替雷利珠单抗的疗效与曲妥珠单抗联合化疗的疗效次要目的：1.进一步比较Zanidatamab 联合化疗，联合或不联合替雷利珠单抗与曲妥珠单抗联合化疗的疗效；2.评价Zanidatamab 联合化疗，联合或不联合替雷利珠单抗的安全性和耐受性；3.评价Zanidatamab 联合化疗，联合或不联合替雷利珠单抗对健康相关生活质量（HRQoL）的影响；4.评价Zanidatamab 联合化疗，联合或不联合替雷利珠单抗的药代动力学（PK）；5.评价替雷利珠单抗联合化疗和Zanidatamab 的PK；6.评价Zanidatamab 联合化疗，联合或不联合替雷利珠单抗的免疫原性；7.评价替雷利珠单抗联合化疗和Zanidatamab 的免疫原性

[Translation]

Primary objective: To compare the efficacy of zanidatamab combined with chemotherapy, with or without tislelizumab, and the efficacy of trastuzumab combined with chemotherapy in subjects with unresectable locally advanced, recurrent or metastatic HER2-positive GEA. Secondary objectives: 1. To further compare the efficacy of zanidatamab combined with chemotherapy, with or without tislelizumab, and trastuzumab combined with chemotherapy; 2. To evaluate the safety and tolerability of zanidatamab combined with chemotherapy, with or without tislelizumab; 3. To evaluate the effect of zanidatamab combined with chemotherapy, with or without tislelizumab on health-related quality of life (HRQoL); 4. To evaluate the pharmacokinetics (PK) of zanidatamab combined with chemotherapy, with or without tislelizumab; 5. To evaluate the PK of tislelizumab combined with chemotherapy and zanidatamab; 6. To evaluate the immunogenicity of zanidatamab combined with chemotherapy, with or without tislelizumab; 7. To evaluate the efficacy of tislelizumab combined with chemotherapy and zanidatamab Immunogenicity

Start Date27 Dec 2021

Sponsor / Collaborator

BeiGene (Shanghai) Co. Ltd.

CTR20212322 / TerminatedPhase 3

比较欧司珀利单抗（BGB-A1217）联合替雷利珠单抗（BGB-A317）与度伐利尤单抗治疗同步放化疗后无疾病进展的、经PD-L1表达筛选、不可切除局部晚期非小细胞肺癌患者的3期、随机、开放性研究

[Translation] A phase 3, randomized, open-label study comparing osperlimab (BGB-A1217) plus tislelizumab (BGB-A317) with durvalumab in patients with PD-L1-selected, unresectable locally advanced non-small cell lung cancer who have not progressed after concurrent chemoradiotherapy

主要目的： 1.比较A组（欧司珀利单抗+替雷利珠单抗）和C组（度伐利尤单抗）治疗同步放化疗（cCRT）后无疾病进展的、PD-LI表达水平≥ 50%的局部晚期非小细胞肺癌（LA NSCLC）患者的无进展生存期（PFS），由独立审查委员会（IRC）根据实体瘤疗效评价标准（RECIST）1.1版评估； 2.比较A组（欧司珀利单抗+替雷利珠单抗）和C组（度伐利尤单抗）治疗cCRT后无疾病进展的、PD-LI表达水平≥ 1%的LA NSCLC患者的PFS，由IRC根据RECIST 1.1版评估。

[Translation]

Main objectives: 1. To compare the progression-free survival (PFS) of patients with locally advanced non-small cell lung cancer (LA NSCLC) with PD-LI expression level ≥ 50% who have not progressed after concurrent chemoradiotherapy (cCRT) between group A (ospelizumab + tislelizumab) and group C (durvalumab), as assessed by an independent review committee (IRC) according to RECIST version 1.1; 2. To compare the PFS of patients with LA NSCLC who have not progressed after cCRT with PD-LI expression level ≥ 1% between group A (ospelizumab + tislelizumab) and group C (durvalumab), as assessed by IRC according to RECIST version 1.1.

Start Date04 Nov 2021

Sponsor / Collaborator

BeiGene (Shanghai) Co. Ltd.

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

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

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

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.

01 Jun 2024·Journal of Clinical Oncology

Global, randomized, phase III study of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced/metastatic esophageal squamous cell carcinoma (RATIONALE-306 update): Minimum 3-year survival follow-up.

Author: Ishihara, Ryu ; Yoon, Harry H. ; Peng, Yanyan ; Yan, Shican ; Tougeron, David ; Shu, Yongqian ; Kato, Ken ; Jiang, Yi ; Wyrwicz, Lucjan S. ; Raymond, Eric ; Lin, Chen-Yuan ; Xu, Jianming ; Zhang, Jingdong ; Hubner, Richard ; Wu, Hongqian ; Pan, Yueyin ; Li, Liyun ; Kojima, Takashi ; Park, Sook Ryun

4032 Background: RATIONALE-306 (NCT03783442) is the first global study to investigate anti-programmed cell death protein 1 therapy in combination with different chemotherapy (chemo) options in the first-line (1L) treatment of advanced/metastatic esophageal squamous cell carcinoma (ESCC). At interim analysis (IA), tislelizumab (TIS) plus chemo demonstrated a statistically significant, clinically meaningful improvement in overall survival (OS) versus placebo (PBO) plus chemo, with a manageable safety profile. Here, we report updated efficacy and safety data with minimum 3 years’ follow-up after study unblinding at IA. Methods: Adults with unresectable locally advanced recurrent/metastatic ESCC and no prior systemic treatment for advanced disease were enrolled and randomized (1:1; stratified by region, prior definitive therapy, and investigator [INV]-chosen chemo) to receive TIS 200 mg (Arm A) or PBO (Arm B) IV every 3 weeks plus chemo (platinum plus fluoropyrimidine or platinum plus paclitaxel), until disease progression or intolerable toxicity. The primary endpoint was OS in the intent-to-treat population. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and duration of response (DoR), all per INV, and safety. Results: In total, 649 patients (pts) were randomized (Arm A, n=326; Arm B, n=323). At a minimum study follow-up of 36.0 months, improvements in OS, PFS, and DoR in Arm A versus B (Table) were maintained relative to the IA. The hazard ratio (HR) for OS with TIS plus chemo versus PBO plus chemo was 0.70 (95% confidence interval: 0.59, 0.83). Similar to the IA, incidences of any-grade (96.6% vs 96.3%) or grade ≥3 (67.0% vs 64.5%) treatment-related adverse events (TRAEs) were comparable between Arms A and B, respectively; treatment-emergent adverse events leading to treatment discontinuation were higher in Arm A (32.1%) versus B (22.1%). In Arm A versus B, respectively, serious TRAEs occurred in 29.9% vs 19.6% of pts; TRAEs leading to death occurred in 1.9% and 1.2%. Conclusions: After minimum 3 years’ follow-up, 1L TIS plus chemo continued to demonstrate clinically meaningful improvements in OS and PFS and durable antitumor response benefit versus PBO plus chemo in pts with advanced/metastatic ESCC, with no new safety signals. Clinical trial information: NCT03783442 . [Table: see text]

01 Jun 2024·Journal of Clinical Oncology

Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: An open-label, single-arm, multicenter phase II study.

Author: Gao, Yang ; Liu, Mulin ; Sun, Yanlai ; Ding, Ke-Feng ; Zhang, Lilin ; Ye, Yao ; Liu, Yue ; Li, Cong ; Zhang, Juan ; Kong, Dalu ; Chen, Gong ; Zhang, Jingdong ; Zhou, Yanbing ; Wei, Shaozhong ; Li, Dandan

3599 Background: Tislelizumab (TIS), an anti-programmed cell death protein 1 (PD-1) antibody, demonstrated improved anti-tumor response and tolerable safety in patients (pts) with previously treated, locally advanced unresectable or metastatic microsatellite instability high/deficient mismatch repair (MSI-H/dMMR) solid tumors, including colorectal cancer (CRC; NCT03736889). Recent studies of other anti-PD-1 antibodies indicate potential clinical benefit of neoadjuvant anti-PD-1 therapy in pts with resectable MSI-H/dMMR CRC. Here, we report efficacy and safety outcomes of neoadjuvant TIS from a multicenter phase II trial (NCT05116085) in this population. Methods: Pts aged ≥18 years with stage II/III MSI-H/dMMR CRC, ECOG PS 0-1, evaluable disease per RECIST v1.1, and eligible for R0 (complete) resection were enrolled. Pts received TIS 200 mg IV every 3 weeks for 3 cycles followed by surgical resection within 10 weeks of first TIS dose. The primary endpoint was major pathological response (MPR) rate (proportion of pts with ≤10% residual viable tumor in the surgically resected primary tumor). Secondary endpoints included pathological complete response (pCR) rate (proportion of pts with absence of residual tumor in the surgically resected specimen), and safety. The R0 resection rate was an exploratory endpoint. Results: Overall, 33 pts were enrolled across eight sites in China. The median age of enrolled pts was 52.0 years (range: 23-84), 14 (42.4%) pts were male. Ten (30.3%) pts had rectal cancer and 23 (69.7%) colon cancer. At study entry, clinical tumor (T) stage was reported as T2, T3, and T4 in 1 (3.0%), 7 (21.2%), and 25 (75.8%) pts, respectively, and node (N) stage as N0, N1, and N2 in 6 (18.2%), 14 (42.4%), and 13 (39.4%) pts, respectively. All pts had a metastasis (M) stage of M0. A total of 29 (87.9%) pts underwent surgery and were evaluable for efficacy endpoints. Surgery was not performed in 4 pts, 3 of whom were managed non-operatively (1 pt had progressive disease). MPR and pCR rates were 89.7% and 62.1%, respectively (Table). Any-grade and grade ≥3 TIS-related adverse events (TRAEs) were reported in 20 (60.6%) and 1 (3.0%) pts, respectively. Two (6.1%) pts experienced serious TRAEs; no TRAEs led to death or surgery cancellation. One pt (3.0%) experienced a TRAE (grade 2 hypothyroidism) leading to surgery delay. No grade ≥3 or serious TIS-related surgery-relevant adverse events were reported. Immune-mediated adverse events were reported in 10 (30.3%) pts (all grade 1-2). Conclusions: Neoadjuvant TIS was associated with high MPR and pCR rates and an acceptable safety profile, and did not compromise surgery in pts with resectable MSI-H/dMMR CRC. Clinical trial information: NCT05116085 . [Table: see text]

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

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

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