Tislelizumab

BeiGene Announces Positive Topline Results from Phase 3 Trial of Tislelizumab in Combination with Chemotherapy as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

Retrieved on: 
Friday, May 21, 2021
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Infectious causes of cancer, Clinical endpoint, Clinical research, Nasopharyngeal carcinoma, Health, Cancer, Medical research, Nasopharyngeal Cancer (NPC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, NASOPHARYNGEAL CANCER (NPC), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

In the trial results, tislelizumab in combination with chemotherapy demonstrated a statistically significant improvement in PFS in the intention-to-treat (ITT) population when compared to chemotherapy alone, as assessed by an independent review committee (IRC).

Key Points: 
  • In the trial results, tislelizumab in combination with chemotherapy demonstrated a statistically significant improvement in PFS in the intention-to-treat (ITT) population when compared to chemotherapy alone, as assessed by an independent review committee (IRC).
  • Key secondary endpoints include overall survival (OS), IRC-assessed objective response rate (ORR) and duration of response (DoR), and investigator-assessed PFS.
  • Greater intake of fruit and vegetables is associated with lower risk of nasopharyngeal carcinoma in Chinese adults: A case-control study.
  • Metastatic Patterns and Prognosis of de novo Metastatic Nasopharyngeal Carcinoma in the United States.

Asieris and BeiGene Enter into Clinical Collaboration to Evaluate Combinations of APL-1202 and Tislelizumab

Retrieved on: 
Thursday, May 6, 2021
Monoclonal antibodies, Drugs, Medical specialties, Clinical medicine, Immune system, Programmed cell death protein 1, Tislelizumab, Humanized antibody, Cancer immunotherapy, PD-1 and PD-L1 inhibitors

It is currently in phase III/pivotal clinical trials in China as single agent for the first-line treatment of non-muscle invasive for the second-line treatment of NMIBC.

Key Points: 
  • It is currently in phase III/pivotal clinical trials in China as single agent for the first-line treatment of non-muscle invasive for the second-line treatment of NMIBC.
  • Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcR on macrophages.
  • We currently market two internally discovered oncology medicines: BTK inhibitor BRUKINSA(zanubrutinib) inthe United StatesandChina, and anti-PD-1 antibody tislelizumab inChina.
  • The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management.

BeiGene Presents Interim Analysis Results of RATIONALE 303 Trial of Tislelizumab in Second- or Third-Line Non-Small Cell Lung Cancer at the AACR Annual Meeting 2021

Retrieved on: 
Monday, April 12, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Oxygen compounds, Carbamates, Docetaxel, Sanofi, Taxanes, Organic chemistry, Chemistry, Non-Small Cell Lung Cancer, Tislelizumab, the Tislelizumab Clinical Program, BeiGene

\xe2\x80\x9cIn addition, tislelizumab was generally well-tolerated, consistent with known risks from previously reported results across different tumor types.

Key Points: 
  • \xe2\x80\x9cIn addition, tislelizumab was generally well-tolerated, consistent with known risks from previously reported results across different tumor types.
  • A total of 805 patients in 10 countries across Asia, Europe, the Americas, and Oceania were enrolled in the trial.
  • \xe2\x80\x9cTislelizumab was also tolerated among these patients, with a notably lower incidence rate of Grade \xe2\x89\xa53 adverse events compared to docetaxel.
  • Our 5,400+ employees around the world are committed to expediting the development of a diverse pipeline of novel therapeutics.

BeiGene Presents Clinical Data on Sitravatinib in Combination with Tislelizumab at the AACR Annual Meeting 2021

Retrieved on: 
Sunday, April 11, 2021
Oncology, Health, FDA, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Branches of biology, Tyrosine kinase receptors, Cell signaling, AXL receptor tyrosine kinase, MERTK, Bruton's tyrosine kinase, Tumor microenvironment, Zanubrutinib, Vascular endothelial growth factor, TME, TYRO3, Programmed cell death protein 1, Sitravatinib, Tislelizumab, the Tislelizumab Clinical Program, BeiGene

At the time of data cutoff, 16 patients (64%) remained on study treatment.

Key Points: 
  • At the time of data cutoff, 16 patients (64%) remained on study treatment.
  • The combination of sitravatinib and tislelizumab was generally well tolerated and showed promising antitumor activity among patients with advanced PROC, including those who were heavily pretreated.
  • Sitravatinib targets the VEGFR and TAM (TYRO3, AXL, MERTK) receptor families, which are implicated in orchestrating an immunosuppressive tumor microenvironment (TME).
  • We currently market two internally discovered oncology medicines: BTK inhibitor BRUKINSA\xc2\xae (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China.

BeiGene Announces First Commercial Manufacturing Approval for Its State-of-the-Art Biologics Facility in Guangzhou, China

Retrieved on: 
Thursday, April 8, 2021
Other Manufacturing, FDA, Clinical trials, Manufacturing, Biotechnology, Other Health, Health, Pharmaceutical, Oncology, Life sciences, Health sciences, Biotechnology, BeiGene, Biopharmaceutical, Zanubrutinib, WuXi Biologics, Tislelizumab, BeiGene

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced approval from the China National Medical Products Administration (NMPA) for BeiGene to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its state-of-the-art biologics facility in Guangzhou, China.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced approval from the China National Medical Products Administration (NMPA) for BeiGene to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its state-of-the-art biologics facility in Guangzhou, China.
  • At over one million square feet (100,000 square meters) and 8,000 liters of biologics capacity approved for commercial supply, this wholly owned facility will immediately begin production of commercial supply of tislelizumab for the China market.
  • View the full release here: https://www.businesswire.com/news/home/20210407005897/en/
    BeiGene State-of-the-Art Biologics Facility in Guangzhou, China (Photo: Business Wire)
    We started building this large-scale, commercial biologics manufacturing facility in 2017 to meet our expected future demand.
  • We currently market two internally discovered oncology medicines: BTK inhibitor BRUKINSA (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China.

BeiGene Initiates Phase 1 Clinical Trial for HPK1 Inhibitor BGB-15025

Retrieved on: 
Wednesday, March 10, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Drugs, BeiGene, Health care, Tislelizumab, Pharmaceutical companies, BGB-15025, Tislelizumab, BeiGene

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the first patient has been dosed in a Phase 1 clinical trial of BGB-15025, its investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the first patient has been dosed in a Phase 1 clinical trial of BGB-15025, its investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor.
  • This first-in-human Phase 1 trial (NCT04649385) will assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-15025 alone and in combination with tislelizumab in patients with advanced solid tumors.
  • BGB-15025 is an investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor discovered and being developed by BeiGene.
  • Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and two pivotal Phase 2 trials.

BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Second- or Third-line Non-Small Cell Lung Cancer

Retrieved on: 
Friday, March 5, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Drugs, Orphan drugs, Health sciences, Health care, Lung cancer, Breakthrough therapy, Monoclonal antibodies, BeiGene, Non-small-cell lung carcinoma, Zanubrutinib, Oncology, Tislelizumab, Non-Small Cell Lung Cancer, Tislelizumab, the Tislelizumab Clinical Program, BeiGene

We are excited to submit the third marketing application for tislelizumab from its broad program in lung cancer which consists of five completed or ongoing Phase 3 trials.

Key Points: 
  • We are excited to submit the third marketing application for tislelizumab from its broad program in lung cancer which consists of five completed or ongoing Phase 3 trials.
  • BeiGene expects to present results from the RATIONALE 303 trial at an upcoming medical conference in the first half of 2021.
  • The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy.
  • We currently market two internally discovered oncology medicines: BTK inhibitor BRUKINSA (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China.

BeiGene Announces Closing of Collaboration with Novartis to Develop and Commercialize Anti-PD-1 Antibody Tislelizumab in North America, Europe and Japan

Retrieved on: 
Friday, February 26, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Medical specialties, Medicine, Clinical medicine, Monoclonal antibodies, Immune system, Immunology, Programmed cell death protein 1, Humanized antibody, Novartis, Tislelizumab, Tislelizumab, the Tislelizumab Clinical Program, BeiGene

The companies have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals.

Key Points: 
  • The companies have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals.
  • We are excited to collaborate with Novartis to achieve the global opportunity of this potentially differentiated anti-PD-1 antibody.
  • Each party retains worldwide rights to commercialize its proprietary products in combination with tislelizumab.
  • Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcR on macrophages.

BeiGene Announces Positive Topline Results for Global Phase 3 Trial of Tislelizumab in Esophageal Squamous Cell Carcinoma

Retrieved on: 
Wednesday, January 27, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Clinical medicine, Medicine, Cancer treatments, Health, Chemotherapy, Occupational safety and health, Oncology, BeiGene, Esophageal Squamous Cell Carcinoma (ESCC), Tislelizumab, Tislelizumab Clinical Program, BeiGene

In the trial results, tislelizumab demonstrated a statistically significant and clinically meaningful improvement in OS in the intention-to-treat (ITT) population, when compared to chemotherapy.

Key Points: 
  • In the trial results, tislelizumab demonstrated a statistically significant and clinically meaningful improvement in OS in the intention-to-treat (ITT) population, when compared to chemotherapy.
  • The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified.
  • We are excited to announce the improved overall survival observed in another Phase 3 trial for tislelizumab when compared to chemotherapy standard of care.
  • BeiGene plans to discuss the RATIONALE 302 data with health authorities globally and present data at an upcoming medical conference.

China National Medical Products Administration Approves Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, January 14, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Lung cancer, Clinical medicine, Medicine, Non-small-cell lung carcinoma, Small-cell carcinoma, Cancer, Treatment of lung cancer, PARAMOUNT trial, Non-Small Cell Lung Cancer, Tislelizumab, Tislelizumab Clinical Program, BeiGene

This is the third approval in China for tislelizumab, and its first in a lung cancer indication.

Key Points: 
  • This is the third approval in China for tislelizumab, and its first in a lung cancer indication.
  • Tislelizumab is being investigated in a broad clinical program, including five Phase 3 trials in lung cancer indications.
  • We are grateful to have a new treatment available in the front-line setting for patients with advanced squamous non-small cell lung cancer, said Jie Wang, M.D., Ph.D., National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
  • The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy.