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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Esophageal Squamous Cell Carcinoma |
| Drug: | Tevimbra (tislelizumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
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:
Source:
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)...
Source:
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:
More C2 evidence
Source:
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:
Source:
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:
