^
    Back
    Association details:
    Biomarker:PD-L1 expression
    Cancer:Non Small Cell Lung Cancer
    Drug:Tevimbra (tislelizumab-jsgr) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    IASLC-WCLC 2021
    Title:

    P19.01 - RATIONALE-303 Phase 3 Tislelizumab vs Docetaxel in Previously Treated Advanced NSCLC: China Subgroup Analysis

    Published date:
    08/18/2021
    Excerpt:
    Stratification factors included histology...PD-L1 expression...The primary endpoint was OS (ITT and PD-L1)….OS was significantly longer for tislelizumab vs docetaxel (median OS: 17.8 vs 11.5 months; HR=0.62; P<0.0001). OS improvement with tislelizumab was observed in most subgroups...PFS, ORR and DoR were also improved for tislelizumab vs docetaxel....Consistent with the ITT analysis, clinical improvement was shown with tislelizumab in Chinese patients with advanced NSCLC...
    Trial ID:
    RATIONALE-303
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2020
    Title:

    Phase III study of tislelizumab plus chemotherapy vs chemotherapy alone as first-line (1L) treatment for advanced squamous non-small cell lung cancer (sq NSCLC).

    Published date:
    05/13/2020
    Excerpt:
    Chinese pts with histologically confirmed stage IIIB or IV sq NSCLC were randomized (1:1:1) to receive IV Q3W: tislelizumab (200 mg, D1) + paclitaxel (P; 175 mg/m2, D1) and carboplatin (carb; AUC 5, D1) (Arm A); tislelizumab + nab-P (100 mg/m2; D1, 8, and 15) and carb (AUC 5, D1) (Arm B); or P (175 mg/m2, D1) and carb (AUC 5, D1) (Arm C)....median PFS was significantly improved with tislelizumab plus chemotherapy (Arms A and B) compared with chemotherapy alone (Arm C)....
    Secondary therapy:
    carboplatin + paclitaxel; carboplatin + albumin-bound paclitaxel
    DOI:
    10.1200/JCO.2020.38.15_suppl.9554
    Trial ID:
    RATIONALE-307
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous NSCLC

    Excerpt:
    ...Objective Response Rate (ORR) assessed by Independent Review Committee(IRC)`Duration Of Response (DOR) assessed by Independent Review Committee(IRC)`Overall Survival`Progression Free Survival (PFS) as assessed by the investigator`Objective response rate (ORR) as assessed by the investigator`Duration of response (DOR) as assessed by the investigator`health-related quality of life (HRQoL)- measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ LC13) as presented in participants-reported outcomes`health-related quality of life (HRQoL)- measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Core 30 (EORTC QLQ-C30) as presented in participants-reported outcomes`Incidence and severity of treatment-emergent AEs (TEAEs) graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03`PD-L1 expression by IHC...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)

    Excerpt:
    ...Participants must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells....
    Trial ID:
    RATIONALE-303
    More C2 evidence