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Association details:
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
PD-L1 ≥50%....The following continuation maintenance regimens added...Durvalumab ± pemetrexed.
Secondary therapy:
pemetrexed
Evidence Level:
Sensitive: B - Late Trials
Title:

Update on PEARL Phase III trial of Imfinzi monotherapy in Stage IV non-small cell lung cancer

Published date:
12/19/2022
Excerpt:
The PEARL Phase III trial for AstraZeneca’s Imfinzi (durvalumab) did not achieve statistical significance for the primary endpoints of improving overall survival (OS) versus platinum-based chemotherapy as a monotherapy treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC) whose tumour cells express high levels (25% or more) of PD-L1, or in a subgroup of patients at low risk of early mortality. There was an improvement in OS with Imfinzi monotherapy, which was clinically meaningful in the subset of patients with PD-L1 tumour expression greater than 50%, a secondary endpoint.
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)

Excerpt:
PD-L1 high expression
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ATLANTIC)

Excerpt:
...Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Korean Real-world Data on Unresectable Stage III Non-Small Cell Lung Cancer Patients Treated with Durvalumab after Chemoradiotherapy

Published date:
08/08/2023
Excerpt:
This study aimed to investigate real-world evidence for efficacy and safety of durvalumab consolidation (DC) after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC)….High PD-L1 expression (≥50%) and development of RP requiring steroid treatment were significantly associated with longer and shorter rwPFS, respectively.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-world Survival with CRT+durvalumab for Unresectable, Stage III NSCLC in Canada: the RELEVANCE Study

Published date:
08/08/2023
Excerpt:
A total of 342 patients received CRT+ durvalumab and 144 patients received CRT alone (Table 1). Median OS was 44.6 months for CRT+ durvalumab and 21.3 months for CRT alone. In patients who received CRT+ durvalumab, significantly longer median OS was observed in patients with PD-L1 ≥50% vs. PD-L1 <1% (hazard ratio 0.24; 95% confidence interval 0.12, 0.51; P<0.001). Median rwPFS was 24.6 months for patients who received CRT+ durvalumab and 9.6 months for patients who received CRT alone...These real-world Canadian data support the efficacy and safety of CRT+durvalumab in patients with unresectable stage III NSCLC identified in the PACIFIC trial.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Impact of TMB/PD-L1 expression and pneumonitis on chemoradiation and durvalumab response in stage III NSCLC

Published date:
07/15/2023
Excerpt:
Here, in a multi-institutional retrospective cohort study of 328 patients treated with CRT and durvalumab, we identify that very high PD-L1 tumor proportion score (TPS) expression ( ≥ 90%) and increased tumor mutational burden (TMB) are independently associated with prolonged disease control.
DOI:
https://doi.org/10.1038/s41467-023-39874-8
Evidence Level:
Sensitive: C3 – Early Trials
Title:

EP05.01-018 - Chemoradiotherapy Followed by Durvalumab in Unresectable Locally Advanced NSCLC- A Single Institution Experience in Croatia

Published date:
07/12/2022
Excerpt:
We here present the real world data and outcomes of our patients diagnosed with unresectable locally advanced NSCLC and treated with concurrent or sequential chemoradiotherapy, followed by consolidation durvalumab….Patients with PDL1 >/= 50% had singificantly longer PFS (8.13 months vs NR)....Our data support the survival benefit and safety of durvalumab consolidation in patients with locally advanced NSCLC in the real- life setting.
Secondary therapy:
Chemotherapy
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Prognostic and Predictive Role of PD-L1 Expression in Stage III Non-small Cell Lung Cancer Treated With Definitive Chemoradiation and Adjuvant Durvalumab

Published date:
04/19/2022
Excerpt:
Increasing PD-L1 expression was associated with longer PFS (adjusted hazard ratio [aHR], 0.84 per 25% absolute increase in expression; 95% confidence interval [CI], 0.75-0.94; P = .003) and OS (aHR, 0.86 per 25% absolute increase in expression; 95% CI, 0.74-0.99; P = .036). Compared with the no-durvalumab group, PFS was longer for PD-L1 50% to 100% (aHR, 0.44; 95% CI, 0.32-0.60; P < .001) and PD-L1 1% to 49% (aHR, 0.64; 95% CI, 0.47-0.86; P = .003) but not PD-L1 <1% (aHR, 0.84; 95% CI, 0.64-1.10; P = .19)....Increasing tumor PD-L1 expression is prognostic for PFS and OS among patients with stage III NSCLC treated with adjuvant durvalumab, and patients with PD-L1 expression <1% may have limited benefit from adjuvant durvalumab.
DOI:
10.1016/j.ijrobp.2022.03.015
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Consolidative durvalumab outcomes in stage III non-small cell lung cancer in a multi-centre study

Published date:
11/27/2021
Excerpt:
This retrospective, ethics board approved, multi-centre study included all patients with histologically and/or cytologically confirmed unresectable stage III NSCLC, EGFR/ALK wild-type patients who completed concurrent chemoradiation therapy...With the median follow-up of 17.0 months, our multivariable Cox analysis suggested PD-L1≥50% was independently associated with improved OS compared to PD-L1<1% group (HR 0.18, 95%CI 0.04-0.86, P = 0.03). 
DOI:
10.1016/j.ctarc.2021.100496
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Outcomes of patients with unresectable stage III non-small cell lung cancer treated with durvalumab and subsequent therapies after disease progression.

Published date:
05/19/2021
Excerpt:
...89% with PDL-1>50%....A total of 13 patients (29%) progressed on durvalumab; the 12-month PFS was 65.9% (49-79.7) and the 18-month PFS was 59.1% (36.7-76.1). The median PFS observed was 38.4 months (Table 1)....durvalumab in patients with locally advanced NSCLC finds PFS in clinical practice to be consistent with trial data.
DOI:
10.1200/JCO.2021.39.15_suppl.e20531
Evidence Level:
Sensitive: C3 – Early Trials
Title:

P21.05 - Overall Survival by PD-L1 Status in Stage III NSCLC Following Implementation of Durvalumab: The Real-World Application of PACIFIC

Published date:
01/12/2021
Excerpt:
196 patients were identified...Median radiotherapy dose was 60 Gy, 38% received cisplatin, 62% carboplatin...In a real-world population, durvalumab was associated with higher OS in patients with unresectable stage III NSCLC following concurrent chemoradiotherapy. There was a trend for improved overall survival in patients with high expression of PD-L1 (≥50%) from durvalumab...
Secondary therapy:
cisplatin + carboplatin
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Final overall survival and safety update for durvalumab in third- or later-line advanced NSCLC: The phase II ATLANTIC study

Published date:
06/30/2020
Excerpt:
Patients with higher PD-L1 expression (TC ≥ 25 % and ≥90 %) had numerically longer median OS than those with TC < 25 %, regardless of EGFR/ALK status (Fig. 1).
DOI:
10.1016/j.lungcan.2020.06.032
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

PD-L1 expression and progression risk of stage III NSCLC patients on durvalumab consolidation.

Published date:
05/28/2020
Excerpt:
Patients with high PD-L1 (50-100%) expression had significantly lower odds of disease progression and longer PFS compared to those who were negative for PD-L1.
DOI:
10.1200/JCO.2020.38.15_suppl.e21070
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Durvalumab in ≥ 3rd-line advanced NSCLC: Updated results from the phase 2 ATLANTIC study.

Published date:
05/16/2018
Excerpt:
Median OS was 13.3/13.2 months, with a 1-year OS rate of up to 53%, in pts with higher PD-L1 expression….These findings demonstrate durable efficacy and a promising effect on OS with durvalumab in a subset of heavily pretreated, advanced NSCLC pts.
DOI:
10.1200/JCO.2018.36.15_suppl.9058
Trial ID: