PD-L1 ≥50%....The following continuation maintenance regimens added...Durvalumab ± pemetrexed.

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.

PD-L1 high expression

...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))...

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.

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.

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.

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.

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.

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). 

...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.

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...

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).

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.

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.