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    Association details:
    Biomarker:PD-L1 expression
    Cancer:Esophageal Squamous Cell Carcinoma
    Drug:Tevimbra (tislelizumab-jsgr) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Businesswire
    Title:

    TEVIMBRA Approved in U.S. for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy

    Published date:
    03/04/2025
    Excerpt:
    TEVIMBRA® (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1)
    Trial ID:
    RATIONALE 306
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2021
    Title:

    RATIONALE 302: Randomized, phase 3 study of tislelizumab versus chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma.

    Published date:
    05/19/2021
    Excerpt:
    Of these, 157 pts (tisle [n=89], ICC [n=68]) had vCPS ≥10% (PD-L1+ population)...The study met its primary endpoint: tisle clinically and significantly improved OS vs ICC in the ITT population (median OS: 8.6 vs 6.3 m; HR 0.70, 95% CI 0.57-0.85, p=0.0001). Tisle also demonstrated significant improvement in OS vs ICC in the PD-L1+ population...Tisle demonstrated statistically significant and clinically meaningful improvement in OS vs ICC in pts with advanced or metastatic ESCC who had disease progression during or after first-line systemic therapy.
    DOI:
    10.1200/JCO.2021.39.15_suppl.4012
    Trial ID:
    RATIONALE 302
    Test:
    VENTANA PD-L1 (SP263) Assay
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

    Excerpt:
    ...Overall survival (OS) in the PDL-1 Positive Analysis Set`Overall response rate (ORR)`Progression-free survival (PFS)`Duration of response (DOR)`Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30)`HRQoL as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophagus Cancer Module (EORTC QLQ-OES18)`HRQoL as Assessed by European Quality of Life 5-Dimensions Version (EQ-5D-5L Version)`Number of participants experiencing adverse events (AEs)`Number of participants experiencing immune-related AEs`Number of participants experiencing serious adverse events (SAEs)...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Combination of Tislelizumab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-002)

    Excerpt:
    ...PD-L1 expression`ctDNA at baseline, during, and after treatment`CD8 expression at baseline`Tumor mutational burden at baseline...
    Trial ID:
    EC-CRT-002
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Chemoradiation in Combination With Tislelizumab as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

    Excerpt:
    ...PD-L1 expression (CPS) is less than 10....
    Trial ID:
    NCT05919030
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Adjuvant Immunotherapy for Resected Esophageal Squamous Cell Carcinoma with High Risk for Recurrence: a Open-Label, Randomized, Controlled Phase III Trial

    Excerpt:
    ...Sufficient tissue for PD-L1 expression assessment. ...
    Trial ID:
    ChiCTR2100045651