Why Is BeiGene Stock Trading Higher On Wednesday?
Why Is BeiGene Stock Trading Higher On Wednesday?
In G/GEJ adenocarcinoma, the expanded indication is for Tevimbra in combination with platinum-and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic cancer whose tumors express PD-L1 with a TAP score ≥ 5%.On Wednesday, the European Commission approved BeiGene Ltd's (NASDAQ:BGNE) Tevimbra (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
周三，欧洲委员会批准了百济神州（纳斯达克: BGNE）的Tevimbra（tislelizumab）与化疗联合用于食管鳞状细胞癌（ESCC）和胃或胃食道交界腺癌（G/GEJ）的一线治疗。
In ESCC, the expanded indication is for Tevimbra in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score ≥ 5%.
在ESCC中，扩展适应症是Tevimbra与铂金类化疗结合用于一线治疗不可切除、局部晚期或转移性癌症的成年患者，这些患者的肿瘤表达PD-L1，肿瘤面积阳性（TAP）评分≥5%。
Also Read: FDA Casts Doubt On Use Of Merck, Bristol Myers' PD-1 Cancer Drugs For Certain Type Of Gastric Cancer Patients
另请阅读：FDA对默沙东、百时美施贵宝的PD-1癌症药物在某些胃癌患者中的使用表示怀疑。
In G/GEJ adenocarcinoma, the expanded indication is for Tevimbra in combination with platinum-and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic cancer whose tumors express PD-L1 with a TAP score ≥ 5%.
在G/GEJ腺癌中，扩展适应症是Tevimbra与铂金和氟嘧啶类化疗结合用于一线治疗HER2阴性局部晚期不可切除或转移性癌症的成年患者，这些患者的肿瘤表达PD-L1，TAP评分≥5%。
In first-line ESCC, the extension of indication application was based on results from the Phase 3 RATIONALE-306 study.
在一线ESCC中，适应症扩展申请是基于第3阶段RATIONALE-306研究的结果。
The study met its primary endpoint, with first-line Tevimbra in combination with chemotherapy resulting in statistically significant and clinically meaningful overall survival (OS) benefit compared with placebo plus chemotherapy in the intent-to-treat population.
该研究达到了其主要终点，第一线Tevimbra与化疗联合给出了统计学上显著且临床上有意义的总生存期（OS）获益，相较于安慰剂加化疗的意向治疗人群。
The median OS was 17.2 months for Tevimbra with chemotherapy versus 10.6 months for placebo plus chemotherapy, a 34% reduction in the risk of death.
Tevimbra与化疗的中位OS为17.2个月，而安慰剂加化疗的中位OS为10.6个月，死亡风险降低34%。
Three-year OS in the PD-L1 ≥ 5% population was also substantially improved in favor of the Tevimbra arm (median 19.1 versus 10.0 months, respectively), demonstrating a 38% reduction in the risk of death.
在PD-L1≥5%人群中，三年OS也显著改善，支持Tevimbra组（中位19.1个月对比10.0个月）， demonstrating a 38%的死亡风险降低。
The extension of indication application for first-line G/GEJ cancer was based on RATIONALE-305 Phase 3 trial results.
一线G/GEJ癌症适应症申请的扩展是基于RATIONALE-305三期试验结果。
The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with Tevimbra in combination with the investigator's choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy, resulting in a 20% reduction in the risk of death.
该研究达到了主要终点，并显示出统计学显著且临床上有意义的总体生存期（OS）获益，接受Tevimbra联合研究者选择的化疗的患者中位OS为15.0个月，而接受安慰剂加化疗的患者中位OS为12.9个月，导致死亡风险降低了20%。
In the PD-L1 ≥ 5% population, the median OS was 16.4 months for Tevimbra plus chemotherapy compared to 12.8 months for the placebo arm, representing a 29% reduction in the risk of death.
在PD-L1 ≥ 5%人群中，Tevimbra加化疗的中位OS为16.4个月，而安慰剂组为12.8个月，代表死亡风险降低了29%。
Price Action: BGNE stock is up 6.99% at $205.53 at last check Wednesday.
价格动态：百济神州（BGNE）股票在周三最后一次检查时上涨了6.99%，报205.53美元。
