TISLELIZUMAB

China NMPA Approves Tislelizumab for Patients with Microsatellite Instability-High or Mismatch Repair-Deficient Solid Tumors

Retrieved on: 
Friday, March 11, 2022
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, 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 the clinical trial of tislelizumab in patients with MSI-H and dMMR solid tumors demonstrated that tislelizumabs treatment effect was consistent and durable across tumor types and endpoints.

Key Points: 
  • Results from the clinical trial of tislelizumab in patients with MSI-H and dMMR solid tumors demonstrated that tislelizumabs treatment effect was consistent and durable across tumor types and endpoints.
  • Todays approval is a great step for patients in China with MSI-H and dMMR solid tumors.
  • The NMPAs approval of tislelizumab is welcoming news to patients with MSI-H and dMMR solid tumors, which are particularly prevalent among the many patients with cancers of the gastrointestinal tract.
  • We are pleased to have a tissue-agnostic treatment approach with tislelizumab now available to those patients in need.

BeiGene Announces Positive Findings from Phase 3 Trial of Tislelizumab in Combination with Chemotherapy in First-Line Gastric or Gastroesophageal Junction Cancer

Retrieved on: 
Monday, January 24, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Gastric Cancer, Tislelizumab, the Tislelizumab Clinical Program, BeiGene, GASTRIC CANCER, TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

The safety profile of tislelizumab was consistent with that observed in previous trials, with no new safety signals identified with the addition of chemotherapy.

Key Points: 
  • The safety profile of tislelizumab was consistent with that observed in previous trials, with no new safety signals identified with the addition of chemotherapy.
  • The addition of tislelizumab to chemotherapy significantly extended the overall survival for previously untreated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumor expressed PD-L1.
  • Secondary endpoints include progression-free survival (PFS), overall response rate (ORR), duration of response (DoR), and safety.
  • 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.

China NMPA Approves Tislelizumab as Second- or Third-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, January 6, 2022
Biotechnology, Health, Genetics, Pharmaceutical, Oncology, Non-Small Cell Lung Cancer, Tislelizumab, the Tislelizumab Clinical Program, BeiGene, NON-SMALL CELL LUNG CANCER, TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

A supplemental biologics license application for tislelizumab in this indication was previously accepted for review by the China NMPA in March 2021.

Key Points: 
  • A supplemental biologics license application for tislelizumab in this indication was previously accepted for review by the China NMPA in March 2021.
  • This latest approval for tislelizumab demonstrates BeiGenes commitment to bringing innovative, impactful treatments to patients in need.
  • As its third approved lung cancer indication in China, todays approval represents an important milestone, with tislelizumab now available in both front-line and second- or third-line care of NSCLC.
  • The NMPAs approval of tislelizumab is welcoming news to the lung cancer community in China, and we hope this immunotherapy will help address the unmet needs in second- or third-line treatment of NSCLC.

BeiGene Presents Results from Phase 3 Trial of Tislelizumab in Nasopharyngeal Cancer at ESMO Immuno-Oncology Congress 2021

Retrieved on: 
Friday, December 10, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Nasopharyngeal Cancer, Tislelizumab, the Tislelizumab Clinical Program, BeiGene, NASOPHARYNGEAL CANCER, TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

A filing based on these results is currently under review in China, where NPC as an endemic disease remains a significant unmet medical need.

Key Points: 
  • A filing based on these results is currently under review in China, where NPC as an endemic disease remains a significant unmet medical need.
  • Safety results in both arms remained similar to known risks and no new safety signals were identified.
  • The safety profile of tislelizumab and chemotherapy combination was manageable, consistent with known risks of each treatment agent.
  • 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 Inclusion in the China National Reimbursement Drug List (NRDL) of Tislelizumab in Three New Indications, BRUKINSA® (Zanubrutinib) in One New Indication, and the First Listing for Pamiparib

Retrieved on: 
Friday, December 3, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Tislelizumab, BRUKINSA® (zanubrutinib), Pamiparib, TISLELIZUMAB, BRUKINSA® (ZANUBRUTINIB), PAMIPARIB

Since its establishment, the NHSA has accelerated the frequency of adjustment to the NRDL, forming a dynamic mechanism for annual updates.

Key Points: 
  • Since its establishment, the NHSA has accelerated the frequency of adjustment to the NRDL, forming a dynamic mechanism for annual updates.
  • We look forward to working with the NHSA to fulfill the demand for these treatments across China as soon as possible.
  • Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcR on macrophages.
  • Discovered by BeiGene scientists, pamiparib was the first PARP inhibitor approved in both platinum-sensitive and platinum-resistant relapsed ovarian cancer in China.

BeiGene Announces U.S. FDA Acceptance of Biologics License Application for Tislelizumab in Esophageal Squamous Cell Carcinoma

Retrieved on: 
Monday, September 13, 2021
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Esophageal Squamous Cell Carcinoma (ESCC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States, said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.

Key Points: 
  • This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment for these patients in the United States, said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene.
  • Tislelizumab is already approved in five indications in China and has the potential to become a preferred immunotherapy option there.
  • We look forward to continued collaboration with Novartis to work to bring access to tislelizumab to patients around the world.
  • The submission also included safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials.

BeiGene Announces Acceptance of a Supplemental Biologics License Application in China for Tislelizumab in Nasopharyngeal Cancer

Retrieved on: 
Monday, August 23, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Nasopharyngeal Cancer (NPC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, NASOPHARYNGEAL CANCER (NPC), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified with the addition of chemotherapy.

Key Points: 
  • The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified with the addition of chemotherapy.
  • BeiGene expects to present results from the RATIONALE 309 trial at an upcoming medical conference.
  • 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.
  • In January 2021, BeiGene and Novartis entered into a collaboration and license agreement 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 Esophageal Squamous Cell Carcinoma (ESCC)

Retrieved on: 
Thursday, July 8, 2021
Oncology, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Clinical medicine, Gastrointestinal cancer, Medicine, Cancer, Esophageal cancer, ESCC, Squamous cell carcinoma, Breakthrough therapy, Pembrolizumab, Esophageal Squamous Cell Carcinoma (ESCC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene, ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC), TISLELIZUMAB, THE TISLELIZUMAB CLINICAL PROGRAM, BEIGENE

We are excited to submit the eighth marketing application for tislelizumab, of which five have been approved in China.

Key Points: 
  • We are excited to submit the eighth marketing application for tislelizumab, of which five have been approved in China.
  • We look forward to further communication with CDE and hope this medicine will benefit Chinese patients with locally advanced or metastatic ESCC soon.
  • In China, more than 95% of patients are esophageal squamous cell carcinomaii.
  • https://gco.iarc.fr/today/explore
    ii Guidelines for diagnosis and treatment of esophageal cancer in 2018, Health Commission of the people's Republic of China.

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.