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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Tevimbra (tislelizumab-jsgr) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
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:
Source:
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:
Source:
Title:
Dose Escalation/Expansion Study of PT199 (an Anti-CD73 mAb) Administered Alone and in Combination With a PD-1 Inhibitor (the MORNINGSTAR Study)
Excerpt:
...To be assessed for CD73 and other biomarkers (PD-L1) expression....
Trial ID:
Source:
Title:
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
Excerpt:
...Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy....
Trial ID:
More C2 evidence
Source:
Title:
Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With 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:
Source:
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...
Trial ID:
Source:
Title:
A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC
Excerpt:
...Must have positive PD-L1 expression in tumor tissue....
Trial ID:
Source:
Title:
Tislelizumab in Addition to BACE in Patients With NSCLC
Excerpt:
...Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells...
Trial ID:
Source:
Title:
Low-dose nab-paclitaxel plus tislelizumab in elderly patients with previously treated advanced non-small cell lung cancer
Excerpt:
...progression free survival - progression free survival; safety - safety; objective response rate - objective response rate; disease control rate - disease control rate; overall survival - overall survival; expression of PD-L1 - expression of PD-L1; IL - IL...
Trial ID:
Source:
Title:
Tislelizumab combined with recombinant human adenovirus type 5 injection in patients with advanced NSCLC who failed prior immunotherapy: an exploratory single-arm study
Excerpt:
...PD-L1 expression >= 1% (post-line patients do not need mandatory testing); 7. ...
Trial ID:
Source:
Title:
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
Excerpt:
...- Participant must have tumor PD-L1 expression ≥ 1% determined by a local laboratory with an approved assay...
Trial ID:
Source:
Title:
A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
Excerpt:
...Overall Survival (OS)`Objective Response Rate (ORR) by IRC and Investigator Assessment`Duration of Response (DOR) by IRC and Investigator Assessment`Progression-free Survival (PFS) by Investigator Assessment`PFS Based on Programmed Death Ligand 1 (PD-L1) Expression`European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13)`European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status`Number of Participants With Adverse Events...
