Tislelizumab

China NMPA Approves Tislelizumab in Non-Small Cell Lung Cancer and Hepatocellular Carcinoma

Retrieved on: 
Wednesday, June 23, 2021
Oncology, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Cancer, Clinical medicine, Medicine, Health effects of tobacco, Lung cancer, Cancer treatments, Oncology, Infectious causes of cancer, Head and neck cancer, Chemotherapy, Non-small-cell lung carcinoma, Esophageal cancer, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma, Tislelizumab, the Tislelizumab Clinical Program, BeiGene, NON-SMALL CELL LUNG CANCER, HEPATOCELLULAR CARCINOMA, TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

The pivotal clinical program of tislelizumab has seen tremendous progress lately, including two positive Phase 3 trials, one in esophageal cancer and the other in nasopharyngeal cancer.

Key Points: 
  • The pivotal clinical program of tislelizumab has seen tremendous progress lately, including two positive Phase 3 trials, one in esophageal cancer and the other in nasopharyngeal cancer.
  • NSCLC comprises the most common form of lung cancer, although diagnoses are usually delayed with most patients diagnosed at advanced stage.
  • A total of 334 patients in China were enrolled in the trial, randomized 2:1 to either the tislelizumab and chemotherapy arm or the chemotherapy arm.
  • Available at https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-she... ; accessed March 2021.
    iii U.S National Institute of Health (NIH) National Cancer Institute Surveillance, Epidemiology, and End Results Program (SEER) Cancer Stat Facts.

BeiGene Announces First Patient Dosed in Global Phase 3 Trial of Anti-TIGIT Antibody Ociperlimab in Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, June 17, 2021
Oncology, Health, Other Science, Research, Science, Pharmaceutical, Biotechnology, Drugs, Cancer treatments, Clinical medicine, Orphan drugs, Monoclonal antibodies, Cancer immunotherapy, Breakthrough therapy, Pembrolizumab, Tislelizumab, Humanized antibody, PD-1 and PD-L1 inhibitors, Ociperlimab (BGB-A1217), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, OCIPERLIMAB (BGB-A1217), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

This marks the initiation of the first Phase 3 clinical trial in the planned global pivotal program for ociperlimab.

Key Points: 
  • This marks the initiation of the first Phase 3 clinical trial in the planned global pivotal program for ociperlimab.
  • Ociperlimab is a potent anti-TIGIT antibody with intact Fc function, which we believe to be critical for the anti-tumor activities of TIGIT antibodies.
  • Patients will be randomized to receive ociperlimab and tislelizumab combination treatment, pembrolizumab, or tislelizumab alone.
  • Ociperlimab (BGB-A1217) is an investigational humanized IgG 1 monoclonal antibody discovered and being developed globally by BeiGene.

The U.S. FDA Approved IND Application to Investigate Combination of Asieris' APL-1202 and BeiGene's Tislelizumab as Neoadjuvant Therapy for MIBC Patients

Retrieved on: 
Tuesday, June 15, 2021
Drugs, Immunology, Medical specialties, Orphan drugs, Immune system, Monoclonal antibodies, Programmed cell death protein 1, Tumor microenvironment, Tislelizumab, C-Met

APL-1202 is an orallyavailable reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment.

Key Points: 
  • APL-1202 is an orallyavailable reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment.
  • Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcR on macrophages.
  • "We are very pleased that FDA approved the IND application for oral APL-1202 in combination with tislelizumabas a neoadjuvant therapy in MIBC patients," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris.
  • We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

BeiGene Presents Long-Term Efficacy and Safety Results from Three Pivotal Trials of BRUKINSA® (Zanubrutinib) and Tislelizumab at EHA2021

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Friday, June 11, 2021
Health, Science, Pharmaceutical, Research, Oncology, Health sciences, Health, BeiGene, Monoclonal antibodies, Bruton's tyrosine kinase, Novartis, Clinical trial, Tislelizumab, Tislelizumab, BRUKINSA, BeiGene, TISLELIZUMAB, BRUKINSA, BEIGENE

And in the two BRUKINSA trials, our selective next-generation BTK inhibitor showed sustained deep responses and remained well-tolerated in these patients.

Key Points: 
  • And in the two BRUKINSA trials, our selective next-generation BTK inhibitor showed sustained deep responses and remained well-tolerated in these patients.
  • The 35-month follow-up results from the single-arm, open-label, multicenter pivotal Phase 2 trial (NCT03206970) demonstrated BRUKINSAs long-term benefit and tolerability for patients with R/R MCL.
  • BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.
  • BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) Solid Tumors

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Monday, June 7, 2021
Oncology, Health, Other Science, Research, Science, Pharmaceutical, Biotechnology, Hepatology, Medical physics, Microsatellite Instability-High or Mismatch Repair Deficient Solid Tumors, Tislelizumab, the Tislelizumab Clinical Program, BeiGene, MICROSATELLITE INSTABILITY-HIGH OR MISMATCH REPAIR DEFICIENT SOLID TUMORS, TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

Results from our Phase 2 trial demonstrated that tislelizumabs treatment effect was consistent and durable across tumor types and endpoints.

Key Points: 
  • Results from our Phase 2 trial demonstrated that tislelizumabs treatment effect was consistent and durable across tumor types and endpoints.
  • We are encouraged by the data and plan to continue our communications with the CDE, hoping to bring this medicine to more patients.
  • Patients received tislelizumab 200 mg intravenously every three weeks until disease progression, unacceptable toxicity, or withdrawal.
  • Radiological imaging was performed at nine weeks and then every six weeks for the first year of therapy and every 12 weeks thereafter.

BeiGene Presents Clinical Data from Two Pivotal Trials of Tislelizumab at the 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Health sciences, Health, BeiGene, Clinical trial, Mapatumumab, Pelareorep, Tislelizumab, the Tislelizumab Clinical Program, BeiGene, TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

We hope that, with a growing body of clinical evidence, tislelizumab can become a meaningful immunotherapy that can potentially benefit more patients worldwide.

Key Points: 
  • We hope that, with a growing body of clinical evidence, tislelizumab can become a meaningful immunotherapy that can potentially benefit more patients worldwide.
  • In addition, tislelizumab demonstrated a favorable safety profile compared to chemotherapy, with no new safety signals identified.
  • In this pivotal Phase 2 trial, we observed consistent responses across tumor types with tislelizumab and it was generally well tolerated.
  • BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

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.