Blog Exposure - BeiGene Commenced Dosing in Global Phase-3 Trial of Anti-PD-1 Antibody Tislelizumab in Patients with ESCC

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LONDON, UK / ACCESSWIRE / February 02, 2018 / Active-Investors.com has just released a free research report on BeiGene, Ltd (NASDAQ: BGNE). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=BGNE as the Company's latest news hit the wire. On January 31, 2018, the Company announced on that it has dosed first patient in a global Phase-3 clinical trial assessing the safety and efficacy of tislelizumab, an investigational anti-PD-1 antibody, for a potential second-line treatment in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC). Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Tislelizumab is also being studied in non-small cell lung cancer, hepatocellular carcinoma, relapsed/refractory classical Hodgkin lymphoma, and urothelial cancer.

BeiGene Plans to Submit New Drug Application for Tislelizumab in China in 2018

John V. Oyler, Founder, CEO and Chairman of BeiGene, mentioned that the Company will lead the third global Phase-3 study of tislelizumab under its strategic collaboration with Celgene. These studies are designed to support regulatory filings both in China and globally and take advantage of BeiGene's unique global clinical development organization as well as the recent regulatory reforms in China. John added that the Company is looking forward to further expand the development program for tislelizumab and to accomplishing key milestones including a planned NDA submission in China in 2018.

Phase-3 Clinical Trial Design

The Phase-3, open-label, multi-center, randomized trial is designed to compare the efficacy and safety of tislelizumab compared to investigator-chosen chemotherapy as a second-line treatment in patients with advanced unresectable or metastatic ESCC. Around 450 patients will be enrolled in Greater China, Japan, Korea, Belgium, France, Germany, Italy, Spain, the United Kingdom, and the United States. Patients will be randomized to receive eithertislelizumab at 200 mg every three weeks or one of three single-agent chemotherapies, paclitaxel, docetaxel, or irinotecan, as determined by the investigator. The trial's primary endpoint is overall survival, and secondary endpoints include progression-free survival, objective response rate, duration of response, health-related quality of life, safety, and tolerability.

BeiGene Initiated Phase-3 Trial of Tislelizumab in Patients with Liver Cancer in 2017

In December 2017, first patient was dosed in a global Phase-3 clinical trial of tislelizumab in patients with previously untreated advanced hepatocellular carcinoma (HCC or liver cancer). Along with two pivotal Phase-2 trials in China in relapsed/refractory classical Hodgkin lymphoma and urothelial cancer, and a global Phase-3 trial in patients with non-small cell lung cancer, tislelizumab was being evaluated in pivotal trials in four distinct indications.

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer, which includes squamous cell carcinoma, is a disease in which malignant (cancer) cells form in the tissues of the esophagus. The esophagus is a muscular tube that moves food and liquids from the throat to the stomach. Squamous cell carcinoma begins in flat cells lining the esophagus. Smoking and heavy alcohol use increase the risk of this cancer. Esophageal cancer is often diagnosed at an advanced stage because there are no early signs or symptoms. Advanced esophageal cancer is a rapidly fatal disease.

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corp. have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).

About BeiGene, Ltd

Founded in 2010, BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. As of January 01, 2018, the Company has a global team of over 850 employees, including more than 400 scientists and clinicians, in China, the United States, and Australia.

Stock Performance Snapshot

February 01, 2018 - At Thursday's closing bell, BeiGene's stock rose 2.34%, ending the trading session at $138.92.

Volume traded for the day: 363.65 thousand shares, which was above the 3-month average volume of 321.21 thousand shares.

Stock performance in the last month – up 37.80%; previous three-month period – up 50.51%; past twelve-month period – up 285.89%; and year-to-date - up 42.16%

After yesterday's close, BeiGene's market cap was at $6.33 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was flat at the end of the session.

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