BeiGene, Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending an extended authorization for Tevimbra (tislelizumab) in gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC).

BeiGene，Ltd.宣布，欧洲药品管理局人类使用药品委员会（CHMP）发表了积极意见，建议在胃或胃食管交界处（G/GEJ）腺癌和食管鳞状细胞癌（ESCC）中延长Tevimbra（tislelizumab）的授权。

In G/GEJ adenocarcinoma, the CHMP positive opinion 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 G/GEJ cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score  greater than 5%.

在G/GEJ腺癌中，CHMP阳性意见是Tevimbra联合铂类和氟嘧啶类化疗用于HER2阴性局部晚期不可切除或转移性G/GEJ癌的成年患者的一线治疗，其肿瘤表达PD-L1，肿瘤面积阳性（TAP）评分大于5%。

In ESCC, the CHMP positive opinion is for Tevimbra in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic ESCC whose tumors express PD-L1 with a TAP score greater than  5%..

在ESCC中，CHMP的积极意见是将Tevimbra与铂类化疗联合用于无法切除，局部晚期或转移性ESCC的成年患者的一线治疗，这些患者的肿瘤表达PD-L1，TAP评分大于5%。。

“Survival rates in the advanced stages of gastric/gastroesophageal and esophageal cancers are among the lowest of all cancer types despite recent advances, and new treatment options are needed,” said Prof. Florian Lordick, Director and Professor of Oncology of the University Cancer Center Leipzig, Germany.

德国莱比锡大学癌症中心主任兼肿瘤学教授FlorianLordick教授说：“尽管取得了最新进展，但晚期胃癌/胃食管癌和食管癌的生存率在所有癌症类型中最低，需要新的治疗选择。”。

“The RATIONALE-305 and 306 trials showed that tislelizumab plus chemotherapy improved survival compared to treatment with placebo plus chemotherapy, highlighting its potential to deliver better outcomes for eligible patients.”.

“TRIANCE-305和306试验显示，与安慰剂加化疗相比，tislelizumab加化疗改善了生存率，突出了其为符合条件的患者提供更好结果的潜力。”。

“Tevimbra is foundational for BeiGene’s solid tumor portfolio. In line with our commitment to help patients affected by cancer in Europe and across the globe, we recently launched Tevimbra in the EU for eligible patients in both the first- and second-line NSCLC settings and second-line ESCC,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene.

“Tevimbra是BeiGene实体瘤投资组合的基础。根据我们帮助欧洲和全球癌症患者的承诺，我们最近在欧盟推出了Tevimbra，用于一线和二线NSCLC以及二线ESCC的合格患者，”BeiGene实体瘤首席医疗官马克·拉纳萨医学博士说。

“With these CHMP opinions, we are one step closer to bringing this innovative therapy to eligible patients with untreated G/GEJ cancer and ESCC , who face a poor prognosis and limited treatment options.”.

“有了这些CHMP的意见，我们离将这种创新疗法带给未经治疗的G/GEJ癌症和ESCC的合格患者又近了一步，这些患者的预后较差，治疗选择有限。”。

The extension of indication application for first-line G/GEJ cancer is based on results from BeiGene’s RATIONALE-305 (NCT03777657), a randomized, double-blind, placebo-controlled, global Phase III trial to evaluate the efficacy and safety of Tevimbra in combination with chemotherapy as a first-line treatment for patients with advanced unresectable or metastatic G/GEJ cancer.

一线G/GEJ癌症适应症应用的扩展是基于BeiGene的Rational-305（NCT03777657）的结果，这是一项随机，双盲，安慰剂对照的全球III期临床试验，旨在评估Tevimbra联合化疗作为晚期不可切除或转移性G/GEJ癌症患者的一线治疗的疗效和安全性。

The study enrolled 997 patients at research centers across Europe, North America and Asia-Pacific. 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 investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy (n=997; HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011), resulting in a 20% reduction in the risk of death.

该研究在欧洲、北美和亚太地区的研究中心招募了997名患者。该研究达到了其主要终点，并证明了统计学上显着且临床上有意义的总生存期（OS）益处，Tevimbra联合研究者选择的化疗患者的中位OS为15.0个月，而安慰剂加化疗患者的中位OS为12.9个月（n=997；HR:0.80[95%CI:0.70,0.92]；P=0.0011），导致死亡风险降低20%。

In the PD-L1 greater than  5% population, the median OS was 16.4 months for Tevimbra plus chemotherapy compared to 12.8 months for the placebo arm (HR: 0.71 [95% CI, 0.58-0.86]), which represents a 29% reduction in the risk of death..

在PD-L1大于5%的人群中，Tevimbra加化疗的中位OS为16.4个月，而安慰剂组为12.8个月（HR:0.71[95%CI，0.58-0.86]），死亡风险降低29%。。

The extension of indication application for first-line ESCC is based on results from BeiGene’s RATIONALE-306 (NCT03783442), a randomized, placebo-controlled, double-blind, global Phase III study to evaluate the efficacy and safety of Tevimbra in combination with chemotherapy as a first-line treatment in patients with unresectable, locally advanced recurrent or metastatic ESCC.

一线ESCC适应症应用的扩展是基于BeiGene的Rational-306（NCT03783442）的结果，这是一项随机，安慰剂对照，双盲，全球III期研究，旨在评估替维布拉联合化疗作为不可切除，局部晚期复发或转移性ESCC患者的一线治疗的疗效和安全性。

The study enrolled 649 patients at research centers across Europe, North America and Asia-Pacific. The study met its primary endpoint, with first-line Tevimbra in combination with chemotherapy resulting in statistically significant and clinically meaningful OS benefit compared with placebo plus chemotherapy in the intent-to-treat population.

该研究在欧洲、北美和亚太地区的研究中心招募了649名患者。该研究达到了其主要终点，一线Tevimbra联合化疗与安慰剂加化疗相比，在意向治疗人群中产生了统计学上显着且临床上有意义的OS益处。

The median OS was 17.2 months for Tevimbra with chemotherapy versus 10.6 months for placebo plus chemotherapy (HR: 0.66 [95% CI, 0.54-0.80, 1-sided p-value of < 0.0001]), a 34% reduction in the risk of death. Three-year OS in the PD-L1 greater than  5% population was also substantially improved in favor of the Tevimbra arm (median 19.1 versus 10.0 months, respectively; HR: 0.62 [95% CI, 0.49-0.79]), demonstrating a 38% reduction in the risk of death..

Tevimbra联合化疗的中位OS为17.2个月，而安慰剂联合化疗的中位OS为10.6个月（HR:0.66[95%CI，0.54-0.80，单侧p值<0.0001]），死亡风险降低34%。PD-L1大于5%的人群的三年OS也显着改善，有利于Tevimbra组（中位数分别为19.1个月和10.0个月；HR:0.62[95%CI，0.49-0.79]），表明死亡风险降低了38%。。

Condition: Gastric /Junction/Esophageal Adenocarcinoma

条件：胃/交界处/食管腺癌

Type: drug

类型：药物