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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Urothelial Cancer |
| Drug: | Loqtorzi (toripalimab-tpzi) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Safety and Efficacy of Toripalimab for Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma
Excerpt:
...Providing with tumor specimen (for testing the expression of PD -L1 and the infiltrating lymphocytes)...
Trial ID:
Source:
Title:
Safety, Efficacy, and Biomarker Analysis of Toripalimab in Patients with Previously Treated Advanced Urothelial Carcinoma: Results from a Multicenter Phase II Trial POLARIS-03
Published date:
02/01/2022
Excerpt:
Both PD-L1+ and TMB-high (10 mutations/Mb as the cutoff) patients had better ORR than PD-L1− patients (42% vs. 17%, P = 0.002) and TMB-low patients (48% vs. 22%, P = 0.014), respectively. The TMB-high group also showed better PFS (12.9 vs. 1.8 months, P < 0.001) and OS (not reached versus 10.0 months, P = 0.018) than the TMB-low group....Toripalimab has demonstrated encouraging clinical activity in the second-line treatment of mUC with a manageable safety profile. PD-L1 expression and TMB were two independent biomarkers in the study.
DOI:
10.1158/1078-0432.CCR-21-2210
Source:
Title:
Safety, Efficacy and Biomarker Analysis of Toripalimab in Patients with Previously Treated Advanced Urothelial Carcinoma: Results from a Multicenter Phase II Trial POLARIS-03
Published date:
11/05/2021
Excerpt:
Among the intention-to-treat population (n = 151), 85% of the patients experienced treatment-related adverse event (TRAE) and 20% experienced grade 3 and above TRAE. The objective response rate (ORR) was 26% with a disease control rate (DCR) of 45%. The median duration of response, progression-free survival (PFS) and overall survival (OS) were 19.7 months (95% CI: 13.9 to NE), 2.3 months (95% CI: 1.8 to 3.6) and 14.4 months (95% CI: 9.3 to 23.1), respectively. Both PD-L1+ and TMB-high (10 mutations/Mb as the cut off) patients had better ORR than PD-L1- patients (42% versus 17%, p = 0.002) and TMB low patients (48% versus 22%, p = 0.014), respectively. The TMB-high group also showed better PFS (12.9 versus 1.8 months, p < 0.001) and OS (not reached versus 10.0 months, p = 0.018) than the TMB-low group.Toripalimab has demonstrated encouraging clinical activity in the second-line treatment of mUC with a manageable safety profile. PD-L1 expression and TMB were two independent biomarkers in the study.
Source:
Title:
Recombinant humanized anti-PD-1 monoclonal antibody toripalimab in patients with metastatic urothelial carcinoma: Results of an open-label phase II clinical study Polaris-03.
Published date:
05/13/2020
Excerpt:
PD-L1 expression results were obtained from 141 patients. PD-L1+ patients (n=46) had significant better ORR than PD-L1- patients (n=95), 41.3% versus 16.8% (p<0.01).
DOI:
10.1200/JCO.2020.38.15_suppl.5040
Trial ID:
Source:
Title:
Recombinant humanized anti-PD-1 monoclonal antibody toripalimab in patients with metastatic urothelial carcinoma: Preliminary results of an open-label phase II clinical study (POLARIS-03).
Published date:
02/14/2020
Excerpt:
PD-L1+ patients (n = 39, 32.2%) had significant better ORR than PD-L1- patients (n = 82), 38.5% versus 13.4%...Toripalimab elicited a favorable 38.5% ORR in PD-L1+ patients.
Trial ID:
