BeiGene Announces Updated Results of RATIONALE-309, Phase 3 Clinical Trial of BeiGene(R) in First-Line Recurrent or Metastatic Nasopharyngeal Carcinoma at ASCO Plenary Session Series

The trial's secondary endpoint results were consistent with the interim analysis

BEIJING, China, CAMBRIDGE, MA, USA and BASEL, Switzerland, April 19, 2022 /PRNewswire/ -- BeiGene (NASDAQ: BGNE; HK: 06160; S: 688235) is A global science-based biotechnology company focused on developing innovative, affordable medicines designed to improve outcomes and improve access to medicines for patients around the world

Updated efficacy analysis showed that at a median follow-up time of 15.

Mark Lanasa, MD, Chief Medical Officer, Solid Tumors, BeiGene, said: "The updated data analysis further supports the combination of ^Bazaar® and chemotherapy as a potential standard first-line treatment for patients with RM-NPC, and the data analysis of this study can be used in the high-profile ASCO.

The primary endpoint (PFS) and two secondary endpoints (PFS2, OS) were updated for analysis based on the most recent database with a cutoff date of September 30, 2021

The study's principal investigator, Professor Zhang Li from the South China State Key Laboratory of Oncology and Sun Yat-Sen University Cancer Center, said: "According to the updated data from the RATIONALE-309 trial, Baizean® ^combined with chemotherapy showed PFS in patients with advanced nasopharyngeal carcinoma.

The crossover design of this trial allowed patients in the placebo-combination chemotherapy arm to receive Bazaar® monotherapy after ^disease progression

Biomarker analyses (including PD-L1 and gene expression profiling [GEP]) were also performed for exploratory endpoints

^{In August 2021, China's National Medical Products} Administration (NMPA) accepted the marketing application for a new indication of Baizean® combined with chemotherapy as a first-line treatment for patients with RM-NPC

ASCO plenary meeting series  related schedule 

Wednesday, April 20, 2022; 3am-4pm GMT

(Tuesday, April 19, 2022; 3pm - 4pm ET)

Prof.

About Nasopharyngeal Cancer

Nasopharyngeal carcinoma (NPC) is a rare cancer in which malignant cells form in nasopharyngeal tissue, with approximately 133,000 new cases diagnosed and 80,000 deaths worldwide each year

Recurrent or metastatic NPC is more common in Southeast Asia

About the RATIONALE-309 clinical trial

RATIONALE-309 is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial (NCT03924986) evaluating Bazaar in ^combination with gemcitabine and cisplatin (arm A) versus placebo in combination with gemcitabine and cisplatin (Panel B) Efficacy and safety as first-line therapy in patients with RM-NPC

The primary endpoint of the trial was progression-free survival (PFS) in the intention-to-treat (ITT) population as assessed by the Independent Review Committee (IRC) according to RECIST version 1.

A total of 263 patients were enrolled in the trial, and 131 and 132 patients were randomly assigned to groups A and B, respectively, with balanced baseline characteristics

About Baizean® ( ^Tislelizumab Injection)

Bazaar® is an anti-programmed death-1 ⁽ PD-1) inhibitor designed to help human immune cells detect and fight tumors

Bai Zean® ^is the first drug developed by BeiGene's immuno-oncology bioplatform and is currently undergoing single-agent and combination therapy clinical trials to develop a broad range of indications for solid tumors and hematological tumors
.
BeiGene has conducted or completed more than 20 registration usability clinical trials of BeiGene® in China and globally ^, including 17 Phase 3 clinical trials and 4 pivotal Phase 2 clinical trials
.

Baizean® has been approved by the China National Medical ^Products Administration (NMPA) for 8 indications, of which multiple approvals have been obtained for NSCLC
.
Another indication of Bai Zean® ^has
been accepted in China and is currently under review .
Bazaar® is a potential treatment for unresectable recurrent locally advanced or metastatic ^ESCC after prior systemic therapy in the United States, and a potential treatment for NSCLC and ESCC in Europe
.
In January 2021, BeiGene entered into a collaboration with Novartis to accelerate the development and commercialization of Baizean® in North America, Europe and ^Japan
.
 

About BeiGene Oncology

BeiGene continuously promotes the research and development of best-in-class or first-in-class clinical drug candidates through independent research and development or in collaboration with like-minded partners, and is committed to providing effective, accessible and affordable medicines to patients around the world
.
The company's global clinical research and development and medical affairs team has about 2,900 people and is still growing.
Currently, it is supporting more than 100 clinical studies worldwide and has recruited more than 14,500 subjects
.
The company has a deep product pipeline and a wide range of experiments.
The experiments have covered more than 45 countries/regions around the world, and all of them are led by the company's internal team
.
The company is deeply engaged in the development of targeted therapy and tumor immunotherapy for hematological and solid tumors, while focusing on the exploration of monotherapy and combination therapy
.
At present, three drugs independently developed by BeiGene have been approved for marketing: ^Baiyueze® (BTK inhibitor, which has been approved for listing in the United States, China, the European Union, the United Kingdom, Canada, Australia and other international markets), Baizean ^® (anti-PD-1 antibody that can effectively avoid Fc-gamma receptor binding, approved for marketing in China) and Baihuize® ⁽ PARP inhibitor, approved for marketing in China)
.

At the same time, BeiGene is also working with other innovative companies to jointly advance the research and development of innovative therapies to meet global health needs
.
In China, BeiGene is selling a number of oncology drugs licensed by Amgen, Bristol-Myers Squibb, EUSA Pharma, and Bio-Tech
.
The company is also working with companies including Mirati Therapeutics, Seagen and Zymeworks to better address current unmet medical needs worldwide
.

In January 2021, BeiGene and Novartis announced a collaboration, granting Novartis the co-development, production and commercialization of BeiGene's anti-PD-1 antibody Baizean® in North America, Europe and ^Japan
.
Based on this fruitful collaboration, including a new drug marketing authorization application (BLA) under review by the FDA, BeiGene and Novartis announced in December 2021 about BeiGene's TIGIT inhibitor ospelimumab in Phase 3 development Options, Partnerships and License Agreements
.
Novartis and BeiGene have also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis oncology drugs in designated areas within China
.
 

About BeiGene

BeiGene is a global, science-based biotechnology company focused on developing innovative, affordable medicines designed to improve outcomes and accessibility for patients around the world
.
The company's extensive drug portfolio currently includes more than 40 clinical candidates
.
The company accelerates the development of diversified and innovative drug pipelines by strengthening independent research and development capabilities and cooperation
.
We are committed to comprehensively improving access to medicines for more than 2 billion people worldwide by 2030
.
BeiGene has built a team of more than 8,000 people on five continents
.
For more information, please visit http:// .

Forward-Looking Statements

^{This press release contains forward-looking statements within the meaning of the Private Securities Litigation} Reform Act of 1995 and other federal securities laws , Political filings and statements of potential commercialization, as well as BeiGene plans, vision, ambitions and goals mentioned under the subheadings "About BeiGene Oncology" and "About BeiGene"
.
These factors include: BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; clinical results of drug candidates may not support further development or marketing approval; actions by regulatory authorities may affect the initiation, timeline, and progress of clinical trials and drug marketing approval; BeiGene's ability to achieve commercial success with its marketed drugs and drug candidates (if approved); BeiGene's ability to obtain and maintain intellectual property protection for its drugs and technologies; BeiGene's reliance on third parties Circumstances in the conduct of drug development, manufacturing and other services; BeiGene's limited experience in obtaining regulatory approval and commercializing pharmaceutical products, and its ability to obtain further working capital to complete the development and commercialization of drug candidates and achieve and maintain profitability; COVID-19 The impact of the COVID-19 pandemic on BeiGene's clinical development, regulatory, commercialization, and other businesses; various categories discussed more fully in the "Risk Factors" section of BeiGene's most recent quarterly report on Form 10-K risks; and discussions of potential risks, uncertainties and other important factors in BeiGene's subsequent filings with the Securities and Exchange Commission
.
All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law
.

references:

[1] Global Cancer Observatory: Cancer Today.
Lyon, France : International Agency for Research on Cancer.
Available at: https://gco.
iarc.
fr/today/data/factsheets/cancers/4-Nasopharynx-fact-sheet.
pdf .
Accessed February 22, 2022