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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

Durvalumab granted Breakthrough Therapy designation by US FDA for treatment of patients with PD-L1 positive urothelial bladder cancer

Published date:
02/17/2016
Excerpt:
AstraZeneca and MedImmune...announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based regimen.
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Non Small Cell Lung Cancer)
New
Title:

Imfinzi approved in the EU for less-frequent, fixed-dose use in unresectable non-small cell lung cancer

Excerpt:
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union and the UK for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells...New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder

Excerpt:
...Complete Remission`Overall Survival`Correlate the expression of PD-L1 on immunohistochemistry at pre-treatment and post- durvaRT treatment with DCR...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Identification of characteristics predictive of long-term survival with durvalumab or durvalumab plus tremelimumab in metastatic urothelial carcinoma

Published date:
09/29/2023
Excerpt:
Identification of characteristics predictive of long-term survival with durvalumab or durvalumab plus tremelimumab in metastatic urothelial carcinoma...Among 360 patients, 88 (24.4%) had OS ≥ 2 years and 272 (75.6%) had OS < 2 years...In multivariable analysis, LTS was significantly associated with ECOG PS, PD-L1 expression...Several baseline clinical characteristics and laboratory measurements were associated with LTS for patients with platinum-refractory mUC treated with durvalumab or durvalumab plus tremelimumab.
DOI:
10.1186/s12885-023-11380-6
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

An adaptive, biomarker directed platform study in metastatic urothelial cancer (BISCAY) with durvalumab in combination with targeted therapies

Published date:
09/28/2019
Excerpt:
PD-L1+ve patients are 41% in durvalumab arm, 38% (Vistusertib + durvalumab arm), 29% (AZD4547 + durvalumab) and 20% (AZD4547). Durvalumab monotherapy (n = 29) had an ORR of 28%, Vistusertib + durvalumab (21%), AZD4547 + durvalumab (39%), and AZD4547 (20%) (table).
Evidence Level:
Sensitive: C3 – Early Trials
New
Source:
Title:

Optimal PD-L1-high cutoff for association with overall survival in patients with urothelial cancer treated with durvalumab monotherapy

Excerpt:
...PD-L1 expression was significantly associated with OS, PFS, and objective response rate (P < 0.001 for each)…
DOI:
10.1371/journal.pone.0231936
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Evaluation of PD-L1 biomarker for immune checkpoint inhibitor (PD-1/PD-L1 inhibitors) treatments for urothelial carcinoma patients: A meta-analysis

Excerpt:
Only one year overall survival of durvalumab was significantly associated with PD-L1 expression.