PD-L1 (SP263) ESCC CDx Sty_BeiGene Phase II Sty BGB-A317-A1217-203
Research type
Research Study
Full title
Performance of VENTANA PD-L1 (SP263) CDx Assay with OptiView DAB IHC Detection on the BenchMark ULTRA Instrument for Determining the PD-L1 Expression Level in Esophageal Squamous Cell Carcinoma (ESCC) Specimens for BeiGene Phase II Study BGB-A317-A1217-203
IRAS ID
296178
Contact name
Reena Merard
Contact email
Sponsor organisation
Roche Tissue Diagnostics
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
BGB-A317-A1217-203 EudraCT number, 2020-004658-32
Duration of Study in the UK
1 years, 6 months, 18 days
Research summary
Summary of Reserch
Drug study BGB-A317-A1217-203 is investigating the clinical efficacy of a new therapy combination in patients with recurrent or metastatic esophageal squamous cell carcinoma. Patients with this disease have a median survival of only 8-10 months and an expected 5-year survival rate <5%. The investigational drugs target biomarkers called TIGIT and PD-1. Research shows that high expression of PD-L1 may predict which patients benefit most from drugs that target these biomarkers. In order to ethically prevent including patients in this trial who may not derive therapeutic benefit due to low PD-L1 expression and thereby delay an alternative treatment, this trial has included PD-L1 expression status as an inclusion criteria (besides other inclusion/exclusion criteria provided in 17-1 and 17-2). As there is no Health Authority approved diagnostic test for PD-L1 expression for this therapeutic combination in this patient population, PD-L1 expression will be determined using the investigational VENTANA PD-L1 (SP263) CDx Assay. The results of the BGB-A317-A1217-203 study will be used to support the market approval of both the drug therapies and the investigational CDx assay in this patient population. Roche Tissue Diagnostics (hereafter IVD manufacturer), has performed numerous analytical verification studies to ensure the assay is accurate and reproducible, and has trained pathologists in assay interpretation (described further in A-22) in order to limit patient risk as best as possible. Diagnostic study D163079 protocol provides instructions to the testing laboratory on how to perform staining and interpretation of the investigational CDx assay in the context of this drug study. Samples used for testing are collected and consented for under the BeiGene clinical study protocol BGB-A317-A1217-203 and all aspects of patient management are covered under the pharmaceutical protocol. These samples are collected per standard of care medical procedure and would be a normal component of a patient’s medical journey.
Summary of results
The sponsor of the pharmaceutical trial (Study BGB-A317-A1217-203) would not pursue CDx filing and
data from this study will not be used to support a regulatory submission. No diagnostic data analyses
were performed for the diagnostic study objectives; therefore, this CDx study did not meet its
objectives. No adverse events were reported during this study, and no safety risks associated with the
investigational product were identified.REC name
West of Scotland REC 3
REC reference
21/WS/0041
Date of REC Opinion
31 Mar 2021
REC opinion
Favourable Opinion