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    Association details:
    Biomarker:No biomarker
    Cancer:Esophageal Squamous Cell Carcinoma
    Drug:Tevimbra (tislelizumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Korea Biomedical Review
    Title:

    BeiGene’s tislelizumab wins nod in Korea to treat esophageal cancer

    Published date:
    11/21/2023
    Excerpt:
    BeiGene Korea...obtained the Ministry of Food and Drug Safety’s approval for Tevimbra Inj. 100mg (ingredient: tislelizumab) to treat esophageal squamous cell carcinoma (ESCC)...Specifically, anti-PD-1 immunotherapy Tevimbra has been authorized as monotherapy in adults with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) who are unable to continue prior platinum-based chemotherapy or who have relapsed or progressed since its administration.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    BeiGene Press Release
    Title:

    China NMPA Approves Tislelizumab for Patients with Second-Line Esophageal Squamous Cell Carcinoma

    Published date:
    04/15/2022
    Excerpt:
    BeiGene...announced that the China National Medical Products Administration (NMPA) has granted approval to BeiGene’s anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    BeiGene Press Release
    Title:

    BeiGene Announces Positive CHMP Opinion for Tislelizumab as a Treatment for Advanced or Metastatic ESCC

    Published date:
    07/21/2023
    Excerpt:
    BeiGene...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy...The Marketing Authorization Application (MAA) for ESCC is based on results from BeiGene’s RATIONALE 302, a global, randomized, open-label, Phase 3 study (NCT03430843) to investigate the efficacy and safety of tislelizumab when compared with investigator’s choice chemotherapy as a second-line treatment for patients with unresectable, locally advanced or metastatic ESCC.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Lancet Oncol
    Title:

    Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study

    Published date:
    04/17/2023
    Excerpt:
    Tislelizumab plus chemotherapy as a first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma provided superior overall survival with a manageable safety profile versus placebo plus chemotherapy.
    Secondary therapy:
    Chemotherapy
    DOI:
    10.1016/S1470-2045(23)00108-0
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    BeiGene Press Release
    Title:

    Global Phase 3 Trial of BeiGene’s PD-1 Inhibitor, Tislelizumab, in Combination with Chemotherapy Meets Primary Endpoint in First-Line Advanced Esophageal Squamous Cell Carcinoma

    Published date:
    04/27/2022
    Excerpt:
    BeiGene...announced the Independent Data Monitoring Committee (IDMC) determined at a pre-planned interim analysis that RATIONALE 306, a global Phase 3 trial of tislelizumab in combination with chemotherapy, had met the study’s primary endpoint of overall survival (OS) in patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma (ESCC). The safety and tolerability profile for tislelizumab in combination with chemotherapy at this interim analysis was consistent with previous trials and no new safety signals were identified.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    BeiGene Press Release
    Title:

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

    Published date:
    01/27/2021
    Excerpt:
    ...the global Phase 3 RATIONALE 302 trial of its anti-PD-1 antibody tislelizumab versus investigator’s choice chemotherapy in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior systemic treatment met its primary endpoint of overall survival (OS). In the trial results, tislelizumab demonstrated a statistically significant and clinically meaningful improvement in OS in the intention-to-treat (ITT) population...