PD-L1 expression positive (≥50%)…Adenocarcinoma, large cell, NSCLC NOS…Preferred…(Carboplatin or cisplatin) + pemetrexed + Pembrolizumab (category 1)

Pembrolizumab is considered a standard first-line option for patients with advanced NSCLC and PD-L1 expression ≥ 50% who do not have contraindications to use of immunotherapy…

PD-L1 expression positive (≥50%)...First-line therapy...Preferred...pembrolizumab (category 1)

For patients with high PD-L1 expression (TPS ≥ 50%), non-SCC, and performance status (PS) 0 to 1, clinicians should offer single-agent pembrolizumab…

Among 52 pts vs 71 pts initially treated with pembro + ipi vs pembro + pbo who completed 35 cycles of pembro, ORR was 88.5% vs 87.3%, respectively; OS and PFS rates 1 y from completing pembro were 86.3% vs 87.6% and 72.8% vs 83.5%, respectively...results do not show a survival benefit with ipi+ pembro; 2-y OS rates were similar between groups and safety favored pembro alone....Pembro monotherapy remains a standard of care therapy for metastatic NSCLC with PD-L1 TPS >/= 50%.

The high group was overrepresented by patients high for PD-L1 by both IHC and RNA-seq. OS HRs were better for RNA-seq high versus moderate (HR=0.05, CI 0.00-0.63, p=.02), and RNA-seq high versus low (HR=0.16, CI 0.03-0.86, p=.03) groups...PD-L1 expression by RNA-seq demonstrated improved clinical sensitivity in predicting OS versus standard of care PD-LI IHC in a pembrolizumab treated NSCLC patient cohort.

Merck (NYSE: MRK)...today announced that the Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival (DFS) for the adjuvant treatment of patients with stage IB-IIIA non-small cell lung cancer (NSCLC) following surgical resection....At the interim analysis, there was also an improvement in DFS for patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%) treated with KEYTRUDA compared to placebo...

Pembrolizumab improved overall survival versus chemotherapy in patients with or without baseline brain metastases: benefit was seen in patients with PD-L1 TPS ≥50% (0.67 [95% confidence intervals (CI): 0.44‒1.02] and 0.66 [95% CI: 0.58‒0.76], respectively) and PD-L1 TPS ≥1% (0.83 [95% CI: 0.62‒1.10] and 0.78 [95% CI: 0.71‒0.85], respectively). Progression-free survival was improved, objective response rates were higher, and duration of response was longer with pembrolizumab versus chemotherapy regardless of brain metastasis status. 

Five-year OS rates for pembrolizumab versus docetaxel were 25.0% versus 8.2% in patients with PD-L1 TPS≥50% and 15.6% versus 6.5% with PD-L1 TPS≥1%....Pembrolizumab continued to provide long-term benefit over docetaxel in patients with previously treated advanced NSCLC with PD-L1 TPS ≥50% and ≥1%.

...1181 Korean patients with programmed death-1 ligand 1 (PD-L1)-positive...R/M-NSCLC treated with pembrolizumab or nivolumab...In multivariable analysis, concordance of TPS ≥ 50% in both PD-L1 assays and the development of immune-related adverse events (irAEs) were two significant predictors of better ORR, PFS, and OS. EGFR mutation could also predict significantly worse OS outcomes.

...ORR, n (%)a….32 (82.1)….Pembro continues to show improvements in OS vs chemo as 1L treatment for metastatic NSCLC with PD-L1 TPS ≥50%...Long-term OS and durable responses were observed with pembro monotherapy.

Eligible pts (≥18 y) were randomized to pembro 2 mg/kg Q3W (35 cycles) or doce 75 mg/m2 Q3W (per local standard of care), stratified by TPS (≥50% vs 1–49%)….HRs for OS and PFS numerically favored pembro and ORR was higher with pembro in both the PD-L1 TPS ≥50% and ≥1% groups...These data support the value of pembro for previously treated advanced NSCLC in China.

In this open-label, phase 3 trial, we randomly assigned 305 patients who had previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells...Median progression-free survival was 10.3 months (95% confidence interval [CI], 6.7 to not reached) in the pembrolizumab group versus 6.0 months (95% CI, 4.2 to 6.2) in the chemotherapy group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.37 to 0.68; P<0.001).The estimated rate of overall survival at 6 months was 80.2% in the pembrolizumab group versus 72.4% in the chemotherapy group (hazard ratio for death,0.60; 95% CI,0.41 to 0.89; P=0.005)....In patients with advanced NSCLC and PD-L1 expression on at least 50% of tumor cells, pembrolizumab was associated with significantly longer progression-free and overall survival...  

This prespecified subanalysis of the global, randomized controlled phase III KEYNOTE-024 study of pembrolizumab vs chemotherapy in previously untreated metastatic non-small-cell lung cancer without EGFR/ALK alterations and a programmed death-ligand 1 (PD-L1) tumor proportion score of 50% or greater evaluated clinical outcomes among patients enrolled in Japan....Consistent with results from KEYNOTE-024 overall, first-line pembrolizumab improved progression-free survival and overall survival vs chemotherapy with manageable safety among Japanese patients with metastatic non-small-cell lung cancer without EGFR/ALK alterations and a PD-L1 tumor proportion score of 50% or greater.

The combination of pembrolizumab with chemotherapy is suitable for advanced NSCLC patients who have not received any systematic treatments before, and pembrolizumab monotherapy should also be considered, especially for patients with highly-expressed PD-L1 (≥50%). 

...Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Positive (Tumor Proportion Score [TPS] ≥50%) ...Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 Positive (TPS ≥50%) Tumors...

This study aimed to analyze and explore the efficacy and safety of pembrolizumab combined with chemotherapy as a neoadjuvant treatment….ORR was 90.5% (19/21), 3 patients achieved CR, and ORR in CPS≥20 was 100%, while 62.5% in CPS＜20….Patients with high CPS expression and long cycles of treatment can see higher pCR.

We performed a multicenter retrospective study in 8 Spanish hospitals to evaluate clinical outcomes according to several factors in patients with stage IV high PD-L1 expression NSCLC treated with first-line pembrolizumab in clinical practice....With a median follow-up of 12.6 months (m), the median overall survival (OS) and the progression-free-survival (PFS) were 16.9m (95% CI 12.9-19.2) and 9.9m (95% CI 7.7-12.1), respectively, and the overall response rate (ORR) was 43.3%.

At a median follow-up of 43.7 months (95% CI: 42.6-45.7), patients with PD-L1 TPS ≥90% had a significantly longer median PFS (9.0 versus 5.4 months, HR 0.69, P<0.001) and median OS (30.4 versus 18.6 months, HR 0.70, P<0.01)...Pembrolizumab monotherapy continues to demonstrate a meaningful long-term survival benefit in patients with advanced NSCLC and a PD-L1 TPS ≥90%.

This is a Phase 2, international, multicenter (US and Europe), non-comparative, open-label, multi-cohort (basket) trial (EudraCT No. 2021-003026-69; ClinicalTrials.gov No. NCT05077709). Patients with metastatic adenocarcinoma NSCLC (Cohort A), with a PD-L1 tumor proportion score (TPS) ≥50% and no prior treatments for metastatic disease are being enrolled in Cohort A. Patients receive 3-week cycles of IO102-IO103 (85-85 μg on Day [D] 1 and 8 of Cycle 1 and 2, and D1 thereafter) subcutaneously plus pembrolizumab (200 mg on D1) intravenously, for up to 2 years....Of these, 8 patients (61.5%) had a partial response (4 of the responses have been confirmed), while 4 had stable disease; 1 patient had progressive disease.

This was a retrospective cohort study considering stage IV NSCLC patients diagnosed with BC Cancer between 2018 and 2021 with PD-L1 ≥ 50% who received first-line single agent pembrolizumab... the OS from the treatment initiation date was 14.0 months....The median OS from the date of treatment initiation was 14.0 months (95% CI 11.8–16.2) in the entire population. Median OS was 5.6 months (95% CI 4.8–6.5) in patients who did not receive additional therapy after progression and 22.2 months (95% CI 18.3–26.2) in patients who received subsequent therapy (p < 0.001) (Figure 2).

Real-world data confirm that Pem is an effective, tolerable option for mNSCLC pts with PD-L1 ≥ 50%. PS≥2 pts were not included in the Keynote-024 trial and this subgroup showed significantly shorter mPFS and mOS. The role of Pem in PS≥2 needs to be validated in a prospective phase III trial.

NSCLC patients with more higher PDL1 expression (PD-L1 ≧ 80%) had longer progression-free survival (PFS) PD-L1 ≧ 80% v.s. PD-L1 < 80%, PFS, median, 11.2 v.s 7.0 months, hazard ratio [HR]: 0.52, p = 0.03).

The descriptive analysis of first-line non-small cell lung cancer treatment with pembrolizumab in tumors expressing PD-L1 ≥ 50% in patients...is a non-interventional, retrospective study that was conducted....At the end of the follow-up period on 29 February 2020, 76 patients (27.2%) were still receiving ongoing treatment with pembrolizumab. The median PFS and OS were 9.4 months (95% CI, 6.6 to 11.2) and 17.3 months (95% CI, 12.9 to not reached), respectively (Figure 1)....At 6, 12, and 24 months, the estimated percentages of patients who had no disease progression and were still alive were 57.4% and 70.1% at 6 months, 41.7% and 59.1% at 12 months, and 29.4% and 42.0% at 24 months, respectively.

We performed a retrospective, multicenter study of 300 patients with NSCLC having high PD-L1 expression who received MONO or COMB as first-line treatment between December 2018 and January 2020….With a median follow-up time of 10.6 months (range: 0.1–20.6), the median progression-free survival was 7.1 months with MONO and 13.1 with COMB. The objective response rate was 42.2% with MONO and 67.9% with COMB....In conclusion, COMB may be a suitable first-line treatment for NSCLC with high PD-L1 expression.

7.7% had complete response (CR) as best response, 43.3% had partial response (PR), 15.2% had stable disease (SD), 22.1% had progression disease (PD). Overall Response Rate (ORR): 51%. The median OS and PFS in the overall population were 22.1 m (95% CI, 11.2-33.0) and 11.84 m (95% CI, 4.49-19.19), respectively....CR/PR as best response and receiving treatment beyond progression were predictive of better outcome to pembrolizumab in advanced NSCLC patients with high PD-L1 expression.

...for the pembrolizumab alone group. After a median follow up of 15.7 months, median (95% CI) OS was not reached in the pembrolizumab-chemotherapy group versus 15.6 (9.5-21.7) months in the pembrolizumab alone group (HR OS 0.57, 95% CI 0.28-1.16, p=0.12). Median PFS was 12.4 (6.5-18.3) versus 9.5 (6.3-12.6) months in pembrolizumab-chemotherapy vs pembrolizumab alone groups respectively (HR PFS 0.62, CI 0.32-1.18, p=0.18). Objective response rate (ORR) was higher in the pembrolizumab-chemotherapy group (60% vs 30.3%). Younger patients who received pembrolizumab-chemotherapy had longer OS. There were more hospitalisations in the pembrolizumab-chemotherapy group vs pembrolizumab alone group, 28% vs 18.6%, but immune-related adverse events were similar (32% vs 32.6%).In patients with PD-L1≥50% advanced NSCLC, addition of chemotherapy to first-line pembrolizumab yielded a higher ORR with no additional benefit in PFS or OS. Whilst improved OS was observed in younger patients who received combination treatment, the higher rates of hospitalisations should warrant caution.

In this multicenter retrospective analysis, clinicopathologic and genomic data were collected from patients with metastatic NSCLC....A total of 1200 patients treated with first-line pembrolizumab in combination with platinum-doublet chemotherapy were identified....With increasing PD-L1 TPS levels from <1%, to 1-49%, to 50-89%, to ≥90% there was, respectively, a progressive improvement in ORR (33.6% vs 38.8% vs 50.6% vs 60.3%, P<0.001), mPFS (5.2 vs 6.1 vs 6.9 vs 13.0 months, P<0.001), and mOS (13.1 vs 14.6 vs 34.7 vs 23.1 months, P=0.01)....Patients with better performance status, a low dNLR level, and increasing levels of PD-L1 expression are more likely to benefit from first-line chemoimmunotherapy.

Kaplan-Meier estimates of the 3-year PFS and OS were 24.9% and 47.0% in the PD-L1 TPS ≥90% groups, and 9.4% and 27.7% in the PD-L1 TPS 50-89% group, respectively. A PD-L1 TPS ≥90% was confirmed to be an independent predictor of improved PFS (HR 0.68, p < 0.01) and OS (HR 0.67, p < 0.01) in multivariable analysis....Pembrolizumab monotherapy continues to demonstrate a meaningful long-term survival benefit in pts with advanced NSCLC and a PD-L1 TPS ≥90%.

We conducted a phase II trial to investigate the efficacy and safety of pembrolizumab as first-line therapy for non-small-cell lung cancer (NSCLC) patients with PSs of 2–3 and programmed cell death ligand 1 (PD-L1) expression ≥ 50%....The median progression-free survival (PFS) and 1-year PFS rates were 5.8 months and 20.0%, respectively....Pembrolizumab was effective for the treatment of NSCLC patients with a poor PS and PD-L1 level ≥ 50%.

We performed a retrospective, multicenter study of 300 patients with NSCLC exhibiting high PD-L1 expression who received MONO or COMB as first-line treatment...the median progression-free survival was 7.1 months with MONO and 13.1 months with COMB. The objective response rate was 42.2% with MONO and 67.9% with COMB...COMB may be a promising option for first-line treatment for NSCLC with high PD-L1 expression and good performance status.

This retrospective two-cohort study used technology-enabled abstraction of deidentified electronic health records (EHR cohort) plus enhanced manual chart review (spotlight cohort) to study adult patients with stage IV NSCLC, PD-L1 expression ≥50%...Median OS was 19.6 months (95% CI, 16.6–24.3) and 21.1 months (95% CI, 16.2–28.9), respectively; 3-year OS rates were 36.2% and 38.2% in EHR and spotlight cohorts, respectively. In the spotlight cohort, median rwPFS was 7.3 months (95% CI, 5.7–9.2); 88 patients (38.6%; 95% CI, 32.2–45.2) experienced rwTR of complete or partial response....Real-world outcomes remain consistent with outcomes observed in clinical trials, supporting long-term benefits of first-line pembrolizumab monotherapy for patients with metastatic NSCLC, PD-L1 expression ≥50%

...tumor PD-(L)L1 expression ≥50% treated with pembrolizumab monotherapy had statistically significantly better real world overall survival...mmunotherapy may provide an important survival benefit in individuals with high PD-(L)1 expressing tumors...

...we studied patients with ECOG performance status (PS) of 0–2 who initiated pembrolizumab (1 November 2016 to 31 March 2020) for advanced NSCLC with programmed death-ligand 1 (PD-L1) expression ≥ 50% and without EGFR/ALK/ROS1 genomic alterations….The Kaplan–Meier median rwToT with first-line pembrolizumab monotherapy was 7.4 months (95% CI, 6.3–8.1) for 807 patients with PS 0–1, which was consistent with the median treatment duration in the KEYNOTE-024 trial (7.9 months)....Our findings suggest long-term benefit of first-line pembrolizumab monotherapy for advanced NSCLC with PD-L1 expression ≥ 50% in real-world settings in the US, particularly for patients with good performance status at the start of therapy, irrespective of KRAS status.

This retrospective case series reports adult patients with PD-L1-expressing stage III NSCLC….Four cases of stage IIIA squamous cell carcinoma were disease-controlled by this approach, with two partial and one complete response....This case series suggests that pembrolizumab with sequential CXRT may be beneficial for stage III NSCLC patients with high PD-L1 expression...

Patients with stage IV EGFR/ALK wild type NSCLC and PD-L1 TPS ≥50% who received 1st-line pembrolizumab monotherapy at Dana-Farber Cancer Institute were included….A PD-L1 TPS ≥90% was confirmed to be an independent predictor of improved PFS (HR 0.58, P=0.02) and OS (HR 0.57, P=0.01) at multivariable analysis.

Here we aim to explore the above TCR repertoire features in peripheral blood of NSCLC patients (with PDL1≥50%) treated with single agent pembrolizumab in the first line setting; and correlate them with overall response rate (ORR), PFS and OS….We observed a trend towards increased pre-treatment TCR clonality in patients with objective response to pembrolizumab and statistically significant reduced Shannon diversity (P = 0.042)....Increased pre-treatment TCR clonality and reduced diversity are associated with improved ORR and PFS, but not OS in NSCLC patients with high PD-L1 treated with pembrolizumab monotherapy.

One hundred and sixty-six pts (55%) received MONO and 134 pts (45%) received COMB….In selected subgroup analysis, the PFS benefit of COMB was observed in the population with PD-L1 TPS of ≥90% and age <75 years….Based on this real-world cohort, we believe that COMB may be a suitable first-line treatment for highly PD-L1 expressing NSCLC...

We identified pts initiating 1L pembro with PD-L1 TPS ≥50%....For 240 (54%) pts with PS 0–1, median OS was NR and median rwPFS was 10.0 mo (95% CI 7.2–14.0)….Real-world clinical outcomes with 1L pembro monotherapy for high PD-L1–expressing (TPS ≥50%), advanced NSCLC were consistent with KN024 clinical trial data...

...NSCLC patients (with PDL1≥50%) treated with first line single agent pembrolizumab...Moreover, there was a significantly longer PFS in patients with reduced number of unique clones...reduced diversity are associated with improved RR and PFS...

133 patients with high PD-L1 expression undergoing first-line pembrolizumab monotherapy for NSCLC at 6 Japanese centers...patients with high PD-L1 expression undergoing first-line pembrolizumab monotherapy for NSCLC, PPS was more strongly correlated with OS, relative to the relationship between PFS and OS.

...PD-L1 ≥50%, advanced NSCLC without EGFR or ALK mutations, the addition of pembrolizumab to standard platinum-based chemotherapy seems to be the preferred treatment,...

The aim of this trial is to perform such a comparison as first-line treatment in patients not eligible for locally advanced treatment who have expression of PD-L1 on ≥50% of tumor cells….A higher objective tumor response is also expected with the combination of chemotherapy and pembrolizumab compared with pembrolizumab alone.

...stage IV NSCLC patients treated with either ChT plus pembrolizumab or pembrolizumab monotherapy...Median PFS was 8.1 months (IO alone group) vs 9.9 months (ChT/IO group)...Median OS was 13.7 months (IO alone group) vs 19 months (ChT/IO group)...analysis revealed that although there was no statistically significant difference between high PD-L1 NSCLC patients receiving ChT/IO vs IO alone with respect to survival...

...stage IV NSCLC patients treated with either ChT plus pembrolizumab or pembrolizumab monotherapy...Median PFS was 8.1 months (IO alone group) vs 9.9 months (ChT/IO group)...Median OS was 13.7 months (IO alone group) vs 19 months (ChT/IO group)...analysis revealed that although there was no statistically significant difference between high PD-L1 NSCLC patients receiving ChT/IO vs IO alone with respect to survival...

...patients with PD-L1 TPS ≥50% metastatic NSCLC without known EGFR/ALK aberrations and good performance status treated with 1L pembro monotherapy experienced median OS of 23 months, similar to the OS observed in phase III pivotal clinical trials, supporting the long-term OS benefits of 1L pembro monotherapy in this patient population.

Eligible patients were randomly assigned (1:1) to pembrolizumab (200 mg once every 3 weeks for up to 35 cycles) or platinum-based chemotherapy....Median OS was 26.3 months (95% CI, 18.3-40.4) for pembrolizumab and 13.4 months (9.4- 8.3) for chemotherapy (hazard ratio, 0.62; 95% CI, 0.48-0.81)....Pembrolizumab provides a durable, clinically meaningful long-term OS benefit versus chemotherapy as first-line therapy for metastatic NSCLC with PD-L1 tumor proportion score of at least 50%.

...we compared the clinical efficacy of PM and PC as first-line treatment in NSCLC patients with a PD-L1 ≥50%...The median progression-free survival (PFS) of PC and PM were 12.37 and 9.60 months (HR:0.44, p <0.001), respectively….The 1-year overall survival rate of PC and PM were 89.0% and 78.3%, respectively. The ORR were 61.7% and 46.9% (p = 0.040), respectively....the addition of pembrolizumab to standard platinum-based chemotherapy should be recommended as the preferred treatment.

...we included adult patients with pathologically confirmed advanced, PD-L1 TPS ≥50% NSCLC who initiated first-line pembrolizumab monotherapy...Approximately 23% received at least 2 years of treatment, suggesting long-term benefit of pembrolizumab monotherapy for PD-L1 TPS ≥50% advanced NSCLC in a real-world setting.

Our aim was to estimate overall survival (OS) and real-world progression-free survival (rwPFS) in France for pembrolizumab monotherapy as first-line treatment for patients with metastatic NSCLC and PD-L1 tumor proportion score (TPS) ≥50%....Clinical outcomes among metastatic NSCLC patients with high PD-L1 expression were consistent with those of KEYNOTE-024, supporting the effectiveness of pembrolizumab...

Upfront pembrolizumab showed efficacy in selected patients with PD-L1 ≥ 50% non-oncogene addicted NSCLC and asymptomatic BMs.

In our large, real-world series18,19 of patients with PD-L1 ≥ 50% (assessed by different IHC assays) aNSCLC treated with first-line pembrolizumab....The PD-L1 tumour cells expression level cut-off of 77.5% was significant by ROC curves on CR/PR (AUC 0.56, P = 0.036...OS was significantly associated with disease response, with 1-year OS of 90.6% in patients with CR/PR, 71.5% in SD and 17.4% in PD (P < 0.001...

CONTRADICTING EVIDENCE: In the real-world scenario NSCLC patients with PD-L1 expression ≥50% treated with first-line single-agent pembrolizumab achieve worse outcomes as compared to the Keynote-024 trial.

...we report the clinical stories of four NSCLC patients with PD-L1 tumor proportion score ≥50% and good performance status, sharing high tumor burden including serosal involvement. After having rapidly progressed on first-line PD-1/PD-L1 inhibitors, they achieved major clinical and radiological response to pembrolizumab-chemotherapy combination. 

A total of 29 patients (88%) had a PD-L1 greater than or equal to 50%. Five patients (15%) started pembrolizumab in the intensive care unit. The median OS was 4.3 months (95% confidence interval [CI]: 0.9-not reached), and the 6-month and 1-year OS rates were 41.5% (95% CI: 27.5%-62.6%) and 32.6% (95% CI: 19.0%-55.9%), respectively....Even when initiated in patients hospitalized for a life-threatening clinical deterioration, pembrolizumab seems to prolong the survival of certain patients with high PD-L1 NSCLC.

In this single-institution retrospective study conducted from May 2017 to October 2019, pembrolizumab was administered to 72 Japanese patients with treatment-naïve advanced NSCLC with PD-L1 tumor proportion score (TPS) ≥50%....The ORR was 70.0% and DCR was 90.0% in the ILD group, while the ORR was 41.9% and DCR was 72.6% in the non-ILD group.

In NSCLC patients with PD-L1 expression ≥50%, pembrolizumab improved progression-free and overall survival compared to chemotherapy.

Patients with higher PD-L1 expression (≥ 75%; n = 90) had a higher objective response rate (ORR) and longer progression-free survival (PFS) compared with those with lower expression (50%-74%; n = 55; ORR, 51% vs. 33%; P = .0305; median PFS, 13.9 months vs. 5.2 months; P = .0111).

Among 33 advanced NSq NSCLC patients with tumor PD-L1 scores ≥ 50% receiving pembrolizumab as first-line therapy, a biopsy diagnosis of NSCC was associated with a significantly longer progression-free survival [median 16.8 vs. 2.3 months; hazard ratio (HR) 0.26; 95% CI 0.10-0.62, P = 0.01] and overall survival (median NR vs. 10.1 months; HR 0.35; 0.12-0.97, P = 0.04) as compared to that of morphological adenocarcinoma.

P and PCT in the real-world setting are associated with similar outcomes; with the limitations of the retrospective study design and short follow-up, P emerges as a preferable 1st-line treatment option for aNSCLC with PD-L1 TPS ≥50%.

CONTRADICTING EVIDENCE: All patients with NSCLC and high PD-L1, treated with first-line pembrolizumab were included... 302 patients were included, 246 with PS 0-1, 56 with PS 2. RR was 72% among patients with PS 0-1 compared to 45% with PS2 (odds ratio (OR) 0.31 (95% CI: 0.17-0.57), p < .001). Median PFS was 2.6 months (95% CI: 1.9-5.1) among patients with PS2 and 11.3 months (95% CI: 8.5-14.4) among those with PS 0-1...

...positive for PD-L1 expression when treated with immune checkpoint inhibitors (ICI), including pembrolizumab (Pb) and nivolumab (Nb)....Results suggest OS benefit for real-world ICI-treated aNSCLC patients with PD-L1 TPS ≥50%, consistent with observations in clinical trials.

CONTRADICTING EVIDENCE: Patients with HER2-positive locally advanced/metastatic breast cancer (LA/MBC) previously treated with pertuzumab (P)-containing regimens have few therapeutic options. The efficacy of P re-treatment combined with trastuzumab (T)+chemotherapy was examined...PFS and OS events were 178 (82.0%) and 84 (38.7%), respectively. Median follow-up time was 14.3 months (mo). Investigator –assessed PFS was significantly better in the PTC group (median PFS 5.7 vs . 4.3 mo; HR=0.713 [95%CI, 0.529-0.961]; log-rank test p=0.025...

In the PD-L1 TPS ≥50% subgroup, PFS HRs were lower for pembrolizumab (HR 0.81; 95% CrI 0.67, 0.98) and pemetrexed + pembrolizumab + platinum (HR 0.36; 95% CrI 0.25, 0.52) vs pemetrexed + platinum. Among all IO-based therapies in this analysis, pemetrexed + pembrolizumab + platinum had the highest PFS and OS benefit vs pemetrexed + platinum in the first-line treatment until progression for advanced nsqNSCLC for both the overall population and high PD-L1 subgroup....Among all IO-based therapies in this analysis, pemetrexed + pembrolizumab + platinum had the highest PFS and OS benefit vs pemetrexed + platinum in the first-line treatment until progression for advanced nsqNSCLC for both the overall population and high PD-L1 subgroup.

1181 patients, No. of treatment was 10.5 and 7.9 for nivolumab and pembrolizumab separately...Factors associated with response were Smoking (+), Previous RT (-), irAE(+) and PD-L1 over 50%(+), for OS were PS(+), EGFR(-), Previous RT(-) and irAE(+)…

...PD-L1 TPS (50-89% vs. 90-100%: HR: 0.65, 95.0% CI: 0.43-1.00; p = 0.04984) were significantly and independently correlated with PFS of pembrolizumab... First-line pembrolizumab particularly benefits patients with PD-L1 TPS ≥90% or low inflammatory states (CRP/ALB<0.3).

Preliminary IHC staining of paired biopsies from evaluable CPK naïve pts with neg/low baseline PD-L1 revealed a notable increase in PD-L1+ tumor cells at Day 15 of 62% (8/13) of pts following treatment with CVA21 and pembro. The current median OS for CPK naïve NSCLC and bladder cancer pts is 9.5 and 11.2 mos, respectively. Prolonged SD was the best ORR observed in pts previously treated with CKP (n = 17)...Systemic CVA21 with pembro has been well tolerated and has mediated encouraging clinical signals of activity in parallel with notable increases in PD-L1 tumor levels within these pt populations.

A total of 221 patients treated with first-line pembrolizumab were included in this study….PD-L1 distribution (50%-89% vs ≥90%), a dNLR <2.6 was confirmed to be an independent predictor of longer mPFS (HR 0.47, 95% CI 0.33 to 0.67, p<0.001) and mOS (HR 0.32, 95% CI 0.21 to 0.49, p<0.001)....Among patients with NSCLC and a PD-L1 TPS ≥50%, a low dNLR has a distinct immune tumor microenvironment and more favorable outcomes to first-line pembrolizumab.

In conclusion, the addition of chemotherapy to pembrolizumab further improves the outcomes of patients with advanced NSCLC and a PD-L1 TPS of at least 50%.

In patients with NSCLC treated with PD-1 blockade with long-term follow up, TMB, PD-L1, and CD8 were each associated with benefit from PD-1 blockade....PD-L1 expression was significantly higher in the responders compared with those with SD/PD group (median 66% vs. 15%, P = 0.002).

50-year-old male, stage IVA non-small cell lung cancer, high expression of PD-L1…. At present, 27 months have passed since the last administration of pembrolizumab, and the disease is under control and the patient is undergoing follow-up observation.

In this report, we describe a 55-year-old male with metastasized programmed death ligand 1 (PD-L1)-high NSCLC...The patient was treated with first-line 200 mg pembrolizumab every 3 weeks.... The patient achieved therapeutic exposure and had an impressive clinical response...a radiological partial tumor response...

When testing anti-PD-1 agents, such as dostarlimab and pembrolizumab, in a cohort of NSCLC explants from stage I-III treatment-naïve patients...Interestingly, responsive tumors presented with a high level of PD-L1 expression (high TPS), had elevated TMB...