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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%
Published date:
06/29/2023
Excerpt:
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%....The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone when administered before surgery.
Secondary therapy:
Chemotherapy
Title:
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%
Published date:
05/26/2023
Excerpt:
Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%....The positive opinion is based on results from the CheckMate -816 trial...
Secondary therapy:
Chemotherapy
Source:
Title:
Real-World Effectiveness of Nivolumab Monotherapy After Prior Systemic Therapy in Advanced Non-Small-Cell Lung Cancer in the United States
Published date:
07/29/2020
Excerpt:
In both cohorts, programmed death ligand 1 expression ≥ 1% and ECOG PS 0-1 were associated with longer OS (P < .05);…
DOI:
10.1016/j.cllc.2020.07.009
Source:
Title:
Two-year survival with nivolumab in previously treated, advanced non-small cell lung cancer: A pooled analysis of real-world patients from France, Germany and Canada.
Published date:
05/28/2020
Excerpt:
...PD-L1 positivity (HR 0.75; 95%CI 0.60-0.93; P= < .0001) were associated with prolonged survival...real-world overall survival at 2-years was consistent with pivotal nivolumab trials overall and in subgroups.
DOI:
10.1200/JCO.2020.38.15_suppl.e21714
Source:
Title:
NIVORAD - A randomised phase 2 trial of nivolumab and stereotactic ablative body radiotherapy in advanced non-small cell lung cancer, progressing after first or second line chemotherapy.
Excerpt:
...These may include biomarkers which are often studied amongst patients with non-small cell lung cancer such as PD-L1 expression, EGFR and KRAS mutational status but also novel biomarkers relating to effects of radiation on the immune response. ...
Trial ID:
Source:
Title:
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
Excerpt:
...Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). ...
More C2 evidence
Source:
Title:
A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy
Excerpt:
...Overall survival (OS)`Progression-free survival (PFS)`Time to next therapy (TTNT)`Best overall response rate (BORR)`Distribution of participant demographics characteristics: Age`Distribution of participant demographics characteristics: Sex`Distribution of clinical characteristics: Smoking status`Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation`Distribution of clinical characteristics: Histology`Distribution of clinical characteristics: TNM classification`Distribution of clinical characteristics: Location of metastases`Distribution of clinical characteristics: EGFR mutation`Distribution of clinical characteristics: ALK translocation`Distribution of clinical characteristics: HER2 mutation`Distribution of clinical characteristics: BRAF mutation`Distribution of clinical characteristics: KRAS mutation`Distribution of clinical characteristics: ROS1 mutation`Distribution of clinical characteristics: MET mutation`Distribution of clinical characteristics: PD-L1 expression`Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells`Incidence of Adverse Drug Reactions`Incidence of Seriousness criteria`Incidence of Intensity/ Grade`Incidence of AE duration`Incidence of Action taken regarding the BMS treatment`Incidence of Incidence rate...
Trial ID:
Source:
Title:
Immunotherapy by Nivolumab for HIV+ Patients
Excerpt:
...Progression Free Survival`Overall Survival`Tolerance`Responses rate according to tissue PD-L1 expression`Quality of life measured by LCSS questionnaire`Duration of response`impact on HIV control and immunological, other associated chronic infection susceptible of reactivation and potential occurrence of autoimmunity...
Trial ID:
Source:
Title:
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC
Excerpt:
...Objective Response Rate (ORR)`Time To Objective Response (TTOR)`Duration of Objective Response (DOOR)`Progression-Free Survival (PFS)`Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12`Overall Survival (OS) by PD-L1 Expression at Baseline`Objective Response Rate (ORR) by PD-L1 Expression at Baseline...
Trial ID:
Source:
Title:
Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases
Excerpt:
...Maximum response rate of distant non-irradiated disease`Progression-free survival`Correlation between tumor PD-L1 expression and clinical outcomes`Patient quality of life`Neurocognitive function, as measured by the HVLT-R`Neurocognitive function, as measured by TMT`Neurocognitive function, as measured by COWA`Acute and late toxicity of SRS + Nivolumab`Imaging indicators of response...
Trial ID:
Source:
Title:
SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung Effects
Excerpt:
...Impact on lung function`OS rates in PD-L1 expressers (≥ 1%) and non-expressers (< 1%)`DFS rates in PD-L1 expressers (≥ 1%) and non-expressers (< 1%)`OS rates (squamous and non-squamous)`DFS rates (squamous and non-squamous)`Measuring immune cell responses with treatment...
Trial ID:
Source:
Title:
18F-PD-L1 PET/CT in Nivolumab Treated Patients With NSCLC
Excerpt:
...The outcome measures of 18F-PD-L1 PET/CT related to the date of the first documented tumor progression as determined by modified RECIST, or death due to any cause`The outcome measures of 18F-PD-L1 PET/CT related to the date of death due to any cause`Correlation between PD-L1 expression measured by 18F-PD-L1 PET/CT and PD-L1 expression measured by IHC...
Trial ID:
Source:
Title:
A Single Arm Prospective Trial of Combining CyberKnife Fractionated Radiosurgery and PD-1 Inhibitor Nivolumab in the Treatment of Limited Number (≤4) of Symptomatic Non-small-cell Lung Cancer Brain Metastases without Driver Mutations
Excerpt:
...PFS - PFS; LC - LC; DBF - DBF; OS - OS; relationship of PD-L1 expression and the clinical outcome - relationship of PD-L1 expression and the clinical outcome; QOL - QOL; Cognitive Function - Cognitive Function; Safety - Safety...
Trial ID:
Source:
Title:
Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads
Excerpt:
...Overall survival`Progression Free Survival as determined by RECIST 1.1`Mutation load as determined by FoundationOne testing`Incidence of adverse events (AEs) graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03`PD-L1 expression as determined by immunohistochemistry...
Trial ID:
Source:
Title:
Evaluation of Efficacy and Toxicity of Nivolumab Monotherapy for Advanced Non-small Cell Lung Cancer After First-line Treatment Failure Based on Second-generation Sequencing and Liquid Chip Platform
Excerpt:
...The positive rate of PD-L1 expression in tumor tissues was detected by immunohistochemistry`PD-L1 expression levels`PD-1 expression levels`Detection of the average number of mutations per megabyte in tumor tissues by NGS`tumor mutation burden`Detect the expression level of cytokines in serum`Serum cytokine levels`Objective Response Rate (ORR) by irRC and RECIST 1.1`Number of participants with treatment-related adverse events as assessed by CTCAE v4.0...
Trial ID:
Source:
Title:
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)
Excerpt:
...Objective Response Rate (ORR) in All Randomized Participants`Time To Response (TTR) in Months for All Confirmed Responders`Duration of Objective Response (DOR) in Months for All Confirmed Responders`Progression Free Survival Rate (PFSR)`Progression-Free Survival (PFS) Time in Months for All Randomized Participants`Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12`Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants`Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants`Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants...
Trial ID:
Source:
Title:
Stereotactic body radiotherapy with immunotherapy in early stage non-small cell lung cancer: tolerability and lung effects
Excerpt:
...Secondary Endpoints- Frequency of treatment related adverse events of all grades and grade ≥ 3 as per CTCAE v. 4- The proportion of patients receiving at least 1, 2, 3, 4, 5 and 6 doses within 16 weeks of commencing nivolumab after SBRT - Local, loco-regional and distant rates of relapse at 3, 6, 12 and 24 months- Overall survival rate (OS) of the 31 patients at 6, 12 and 24 months- Disease Free Survival (DFS) rate of the 31 patients at 6, 12 and 24 months- Estimation of the health related quality of life (HRQoL) score at each time point of analysis Exploratory Endpoints- Assessment of rates of toxicity within percentage of predicted FEV1 bands- Assessment of rates of toxicity within percentage of predicted DLCO bands- OS and DFS rates in PD-L1 expressers (≥ 1%) and non-expressers (< 1%)- OS and DFS rates in squamous and non-squamous subgroups Analysis of research blood and biopsy samples...
Trial ID:
Source:
Title:
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Excerpt:
...Progression-Free Survival in Participants With PD-L1 Expression >= 5%...
Trial ID:
Source:
Title:
Evaluation for efficacy and toxicity of Nivolumab monotherapy for advanced non-small cell lung cancer after first-line treatment failure based on second-generation sequencing and liquid chip platform
Excerpt:
...PD-L1 expression levels - PD-L1 expression levels; PD-L1 expression levels - PD-L1 expression levels; tumor mutation burden - tumor mutation burden; Serum cytokine levels - Serum cytokine levels; Immunotherapy efficacy - Immunotherapy efficacy...
Trial ID:
Source:
Title:
Treatment with immunotherapy before and after surgery for the non small cell lung cancer Tratamiento con immunoterapia antes y después de la cirugía en pacientes con cáncer de pulmón no microcítico
Excerpt:
...-toxicity profile of the combination, the down-staging rate, complete resection rate, time to progression and overall survival, surgical outcome and surgical complications.- Explore the expression of other biomarkers, such as PD-L1, in tumor tissue: at screening and after surgery (resected tumor sample), free DNA and circulating tumor cells in liquid biopsy, describe whether PD-L1 expression is a predictive biomarker for ORR- Describe Progression Free Survival (PFS) in PD-L1+ (>=1%) population- Report imaging response vs pathological response rate El perfil de toxicidad de la combinación, la tasa de estadificación descendente, la tasa de resección completa, el tiempo hasta la progresión y la supervivencia global, el resultado quirúrgico y las complicaciones quirúrgicas.- Explorar la expresión de otros biomarcadores, como PD-L1, en el tejido tumoral: en el cribado y después de la cirugía (muestra de tumor resecada), el ADN libre y las células tumorales circulantes en biopsia líquida, describen si la expresión de PD-L1 es un biomarcador predictivo para ORR- Describa la supervivencia libre de progresión (PFS) en la población PD-L1 + (> = 1%)- Informe de la respuesta de imagen vs tasa de respuesta patológica...
Trial ID:
Less C2 evidence
Source:
Title:
Multi-Center Real-World Outcomes of Nivolumab Plus Ipilimumab and Chemotherapy in Patients with Metastatic Non-Small-Cell Lung Cancer
Published date:
08/31/2023
Excerpt:
All patients were treated with a regimen of platinum-based chemotherapy combined with immunotherapy of nivolumab every three weeks and ipilimumab every 6 weeks....Patients whose programmed death ligand-1 (PD-L1) tumor expression level was ≥1% showed a higher median OS than those with PD-L1 expression of less than 1%.
Secondary therapy:
Chemotherapy
DOI:
https://doi.org/10.3390/biomedicines11092438
Source:
Title:
Final results from a phase II trial of CIMAvax-EGF and nivolumab as second-line (2L) therapy after platinum-based chemotherapy in advanced non-small cell lung cancer (NSCLC).
Published date:
05/25/2023
Excerpt:
Pts with previously treated, immunotherapy-naive advanced NSCLC received 2.4 mg C-E IM every 2 weeks(w) for 4 doses (loading phase) in combination with N 240mg IV every 2 w, then continued monthly maintenance C-E combined with N 240mg IV every 2 w....Pts with PD-L1 expression ≥1% had higher 3-yr OS [38% (90% CI 12, 63)] and 3-year PFS [38% (90% CI 12, 63)] compared to pts with no PD-L1 expression (3-yr OS 23% [90% CI 8, 44] and 3-yr PFS 8% [90% CI 1, 25]).
Secondary therapy:
EGF-PTI
DOI:
10.1200/JCO.2023.41.16_suppl.9135
Trial ID:
Source:
Title:
Five-Year Clinical Outcomes after Neoadjuvant Nivolumab in Resectable Non–Small Cell Lung Cancer
Published date:
02/16/2023
Excerpt:
Two doses of nivolumab (3 mg/kg) were administered for 4 weeks before surgery to 21 patients with Stage I–IIIA NSCLC....The presence of MPR and pre-treatment tumor PD-L1 positivity (TPS ≥1%) each trended toward favorable RFS; HR, 0.61 [95% confidence interval (CI), 0.15–2.44] and HR, 0.36 (95% CI, 0.07–1.85), respectively.
DOI:
https://doi.org/10.1158/1078-0432.CCR-22-2994
Trial ID:
Source:
Title:
PL03.12 - Progression Free Survival and Overall Survival in NADIM II Study
Published date:
07/12/2022
Excerpt:
In the experimental arm, PDL1 expression (≥1%) significantly identified patients with improve PFS (HR: 0.26; 95%CI: 0.08-0.77; P = 0.015). Pathological complete response (pCR) rate was 36.2% in the experimental arm versus 6.8% in the control arm (P = 0.007). None of the patients showing a pCR has progressed or deceased (P LogRank <0.001 and P LogRank= 0.013 for PFS and OS, respectively)....The efficacy of nivolumab in combination with platinum-based chemotherapy in patients with resectable stage IIIA NSCLC is supported by survival data. The benefit is especially observed in patients with tumors with positive PD-L1 expression and in those patients achieving pCR.
Secondary therapy:
Chemotherapy
Trial ID:
Source:
Title:
P78.06 Dynamic Risk Prediction for Disease Control With Nivolumab in Advanced or Recurrent Non-Small Cell Lung Cancer Patients (NewEpoch)
Published date:
01/12/2021
Excerpt:
...patients with advanced or recurrent NSCLC who received nivolumab every 2 weeks as second or third-line treatment...66% had PD-L1 1% or more expression...disease control rate (DCR) and the objective response rate (ORR) at week 25 were 41.2% (95% CI, 34.9%–47.6%) and 18.5% (95% CI, 13.8–24.0), respectively. Median progression-free survival (PFS) was 3.9 months (95% CI, 3.3–5.5) and overall survival (OS) was 13.0 months (95% CI, 11.4–16.5).
Source:
Title:
P78.01 Nivolumab in Second Line Non-Small Cell Lung Cancer – Comparing Real-World Outcomes in England to CheckMate (CM) 017 and 057
Published date:
01/12/2021
Excerpt:
...patients of squamous histology and non-squamous histology patients with PD-L1 expression ≥1%...For squamous-NSCLC...Median OS was 8.4 months (95% CI, 7.2‑9.7 months) compared with a median OS of 9.2 months (95% CI: 7.3-12.6 months) in CM017 (Figure 1). The median DOT in SACT was 3.5 months.For non-squamous...Median OS was 9.2 months (CIs not available) compared with 12.21 months (95% CI: 9.7-15.1 months) in CM057 (Figure 2). Median DOT was 4.1 months
Source:
Title:
Relationship Between Progression-Free Survival, Objective Response Rate, and Overall Survival in Clinical Trials of PD-1/PD-L1 Immune Checkpoint Blockade: A Meta-Analysis
Published date:
06/21/2020
Excerpt:
In a patient-level analysis, data were extracted from available trials of durvalumab...Moderate correlations were observed between ΔORR and OS HR: ITT, -0.63; PD-L1-enriched, -0.53. At the patient level, a positive association was observed between PFS and OS in non-small-cell lung cancer (Kendall's Tau=0.793; 95% confidence interval, 0.789-0.797), head-and-neck squamous-cell carcinoma (0.794; 0.789-0.798), and bladder cancer (0.872; 0.869-0.875).
DOI:
10.1002/cpt.1956
Source:
Title:
Abstract 775: Longitudinal investigation of PD-L1 expression on circulating tumor cells (CTCs) in non-small cell lung cancer (NSCLC) patients treated with nivolumab
Published date:
05/15/2020
Excerpt:
Progression free survival was significantly longer in the patients with 7% or more of PD-L1 positivity rates (n = 8) than in those with less than 7% (n = 8) (p < 0.01) at week 8, suggesting the predictive significance of early evaluation of PD-L1 expression on CTCs after nivolumab treatment.
DOI:
10.1158/1538-7445.AM2020-775
Source:
Title:
RAD51Bme Levels as a Potential Predictive Biomarker for PD-1 Blockade Response in Non-Small Cell Lung Cancer
Published date:
04/08/2020
Excerpt:
The median PFS was significantly higher in RAD51Bme+ patients (p = 0.0216; Figure 3A). Furthermore, patients with RAD51Bme+ disclosed a lower risk of disease progression (HR 0.37; 95% CI: 0.15–0.88; p = 0.025) compared with RAD51Bme-….PD-L1+ and RAD51Bme+ are promising biomarkers to predict response to PD-1 blockade rather than overall prognostic factors in NSCLC’s patients.
Source:
Title:
Efficacy of immune checkpoint inhibitors in lung sarcomatoid carcinoma: Data from a French multicentric cohort
Published date:
10/01/2018
Excerpt:
Pts received by nivolumab (87.2%), pembrolizumab (7.7%) or atezolizumab (5.1%)….PD-L1 status was assessed in 18 tumours (46.1%). In PDL1+ pts, ORR was 53.3% (8/15) and DCR was 66.7% (10/15).
DOI:
10.1093/annonc/mdy288.015
Source:
Title:
Differential Activity of Nivolumab, Pembrolizumab and MPDL3280A according to the Tumor Expression of Programmed Death-Ligand-1 (PD-L1): Sensitivity Analysis of Trials in Melanoma, Lung and Genitourinary Cancers
Excerpt:
Overall, the three antibodies provide a significant differential effect in terms of activity according to PD-L1 expression on tumor cells. The predictive value of PD-L1 on tumor cells seems to be more robust for anti-PD-1 antibody (nivolumab and pembrolizumab), and in the context of advanced melanoma and NSCLC.
DOI:
10.1371/journal.pone.0130142
Source:
Title:
Stage IV Non-small Cell Lung Adenocarcinoma in Complete Response for 5 Years Post-first-line Nivolumab Immunotherapy: Are We Talking about a Cure?
Published date:
10/13/2022
Excerpt:
Our case report demonstrated a full response to first-line Nivolumab in a patient with PD-L1-positive NSCLC having visceral and brain metastases.
