Excerpt:Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):...after prior platinum containing chemotherapy, or...who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%.
Excerpt:TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Urothelial Carcinoma....for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area), as determined by an FDA-approved test.
Evidence Level:Sensitive: A2 - Guideline
New
Title:
BLADDER CANCER: ESMO CLINICAL PRACTICE GUIDELINE FOR DIAGNOSIS, TREATMENT AND FOLLOW-UP†
Excerpt:Atezolizumab or pembrolizumab are alternatives for patients with PD-L1 biomarker-positive tumours who are not eligible for cisplatin-based combination ChT.
DOI:https://doi.org/10.1016/j.annonc.2021.11.012
Evidence Level:Sensitive: A2 - Guideline
New
Excerpt:...the NCCN Panel recommends pembrolizumab, atezolizumab, nivolumab, durvalumab, avelumab, or erdafitinib as preferred second-line systemic therapy options after platinum-based therapy. Atezolizumab and pembrolizumab are also recommended as preferred first-line therapy options for patients who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or in patients who are not eligible for any platinum containing chemotherapy regardless of PD-L1 expression for locally advanced or metastatic disease.
Evidence Level:Sensitive: A2 - Guideline
New
Title:
Atezolizumab for untreated PD-L1-positive advanced urothelial cancer when cisplatin is unsuitable
Excerpt:Atezolizumab is recommended, within its marketing authorisation, as an option for untreated locally advanced or metastatic urothelial cancer in adults whose tumours express PD-L1 at a level of 5% or more and when cisplatin-containing chemotherapy is unsuitable.
Evidence Level:Sensitive: B - Late Trials
Title:
658MO - Cisplatin (cis)-related immunomodulation and efficacy with atezolizumab (atezo) + cis- vs carboplatin (carbo)-based chemotherapy (chemo) in metastatic urothelial cancer (mUC)
Excerpt:PD-L1 IC 2/3 status is associated with longer OS in cis- but not carbo-treated pts with mUC...cis/gem induces immunogenic cell death and enhances antitumour immunity, particularly when combined with atezo.
Evidence Level:Sensitive: B - Late Trials
Title:
CT040 - Updated overall survival (OS) analysis of atezolizumab (atezo) monotherapy vs chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (mUC) in IMvigor130
Excerpt:...in pts with PD-L1-expressing immune cells on ≥5% of the tumor area (IC2/3 per VENTANA SP142 IHC assay….Pts were randomized 1:1:1 to Arm A (atezo + plt/gem [not reported here]), B or C....Exploratory subgroup analyses suggested that OS for IC2/3 pts may be higher in Arm B vs C. In ITT pts, ORR was higher in Arm C, but median DOR was longer in Arm B....benefit of atezo monotherapy as first-line treatment for PD-L1 IC2/3 cisplatin-ineligible mUC..
Evidence Level:Sensitive: B - Late Trials
Title:
Tumor, immune, and stromal characteristics associated with clinical outcomes with atezolizumab (atezo) + platinum-based chemotherapy (PBC) or atezo monotherapy (mono) versus PBC in metastatic urothelial cancer (mUC) from the phase III IMvigor130 study.
Excerpt:PD-L1 IC2/3 was associated with significantly longer OS for atezo mono vs placebo + PBC and a combination of PD-L1 IC2/3, and high TMB (> 10 muts/Mb) identified a pt subset (≈ 14% of BEP) with particularly favorable outcomes with atezo mono vs placebo + PBC; similar results for PD-L1 and TMB were not seen with atezo + PBC vs placebo + PBC.
DOI:10.1200/JCO.2020.38.15_suppl.5011
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma (IMvigor130)
Excerpt:...Representative formalin-fixed paraffin embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD L1 expression prior to study enrollment...
Evidence Level:Sensitive: C3 – Early Trials
Title:
Atezolizumab Plus Magrolimab, Niraparib, or Tocilizumab in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Randomized Umbrella Study
Excerpt:The phase Ib/II MORPHEUS-UC trial (NCT03869190) is evaluating atezolizumab plus magrolimab, niraparib, or tocilizumab in platinum-refractory locally advanced or metastatic (mUC)....Trends were observed for shrinkage of PD-L1+ tumors (atezolizumab, atezolizumab plus magrolimab, atezolizumab plus tocilizumab)…
DOI:10.1158/1078-0432.CCR-23-0798
Evidence Level:Sensitive: C3 – Early Trials
Title:
Updated results of phase II trial using escalating doses of neoadjuvant atezolizumab for cisplatin-ineligible patients with nonmetastatic urothelial cancer (NCT02451423).
Excerpt:PD-L1 positive pts had superior OS (logrank p=0.06) and RFS (p=0.10) relative to PD-L1 negative pts.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Safety and Efficacy of Atezolizumab in Understudied Populations with Pretreated Urinary Tract Carcinoma: Subgroup Analyses of the SAUL Study in Real-World Practice
Excerpt:Patients with metastatic urinary tract carcinoma received atezolizumab 1,200 mg every 3 weeks until disease progression...Patients with PD-L1 expression on ≥5% of tumor-infiltrating immune cells tended to have better outcomes than those with <5% PD-L1 expression...
DOI:10.1097/JU.0000000000001768
Evidence Level:Sensitive: C3 – Early Trials
New
Title:
Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial
Excerpt:Patients were given 1200 mg intravenous atezolizumab every 21 days until progression…119 received one or more doses of atezolizumab. At 17·2 months' median follow-up, the objective response rate was 23% (95% CI 16 to 31), the complete response rate was 9% (n=11), and 19 of 27 responses were ongoing...Responses occurred across all PD-L1 and poor prognostic factor subgroups...Atezolizumab showed encouraging durable response rates, survival, and tolerability, supporting its therapeutic use in untreated metastatic urothelial cancer.
DOI:https://doi.org/10.1016/S0140-6736(16)32455-2