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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Bladder Cancer |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
Pembrolizumab (only for patients whose tumors express PD-L1…
Excerpt:
Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Source:
Title:
Neoadjuvant Pembrolizumab for Muscle-invasive Urothelial Bladder Carcinoma
Excerpt:
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for testing at the study sponsor site and determined to be evaluable for tumor PD-L1 expression prior to study enrolment; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Merck representatives.
Trial ID:
Source:
Title:
1738P - Three-year follow-up update and survival outcomes of the PURE-01 study
Published date:
09/05/2022
Excerpt:
After a median [interquartile range (IQR)] follow-up of 39 (30-47) months, 3-year EFS was 74.4% [95% confidence interval (CI): 67.8-81.7] in ITT population. 36-month OS in the ITT population was 83.8% (95% CI: 77.8- 90.2)...Updated follow-up confirms initial findings from PURE-01, and strengthen the role of single-agent pembrolizumab before RC in PD-L1+ pts.
Trial ID:
Source:
Title:
Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Urothelial Bladder Carcinoma (PURE-01): An Open-Label, Single-Arm, Phase II Study
Published date:
10/20/2018
Excerpt:
pT0 was achieved in 19 patients (54.3%) with PD-L1 CPS ≥ 10% compared with only two patients (13.3%) with CPS < 10% (P = .011; Table 3 and Data Supplement)
DOI:
10.1200/JCO.18.01148
Trial ID:
Source:
Title:
Neoadjuvant Pembrolizumab and Radical Cystectomy in Patients with Muscle-Invasive Urothelial Bladder Cancer: 3-Year Median Follow-Up Update of PURE-01 Trial
Excerpt:
The PURE-01 study (NCT02736266) pioneered the neoadjuvant immune-checkpoint inhibitor (ICI) therapy before radical cystectomy (RC) in patients with muscle-invasive urothelial bladder carcinoma (MIBC)....36-month EFS and OS were 74.4% [95% confidence interval (CI): 67.8-81.7] and 83.8% (95% CI: 77.8- 90.2) in ITT population, respectively….EFS was significantly stratified among PD-L1 tertiles (lower tertile: 59.7% vs medium tertile: 76.7% vs higher tertile: 89.8%, p=0.0013)....At a median follow-up of three-years, PURE-01 results further confirm the sustained efficacy of neoadjuvant pembrolizumab before RC. PD-L1 expression was the strongest predictor of sustained response post-RC.
DOI:
https://doi.org/10.1158/1078-0432.CCR-22-2158
Trial ID:
Source:
Title:
247 Assessment of sensitivity to a PD-1 check point inhibitor and cisplatin in bladder cancer patient-derived xenografts with various levels of PD-L1 expression in HuCD34NCG mice
Published date:
11/09/2020
Excerpt:
CONTRADICTING EVIDENCE: Three bladder PDX models PNX0428, PNX0434 and PNX1028 have been established under informed consent from the patients at the Fox Chase Cancer Center, Philadelphia. These models have been profiled for the levels of PD-L1 protein using immunohistochemical...Despite the presence of ~70% PD-L1 positive cells in the PNX0428 model, these tumors produced minor responses to pembrolizumab in HuCD34NCG mice that correspond to progressive disease in patients.
Secondary therapy:
cisplatin
DOI:
10.1136/jitc-2020-SITC2020.0247
