Long-term survival in patients (pts) with advanced NSCLC in the KEYNOTE-010 study overall and in pts who completed two years of pembrolizumab (pembro)

Herbst, Roy S.; Garon, Edward B.; Kim, D.-W.; Cho, B. Chul; Gracia, J.L. Pérez; Han, Ji‐Youn; Arvis, Catherine Dubos; Majem, Margarita; Förster, Martin; Monnet, I.; Novello, Silvia; Szalai, Zsuzsanna; Gubens, Matthew A.; Su, Wu Chou; Ceresoli, Giovanni Luca; Samkari, Ayman; Jensen, Erin; Lubiniecki, Gregory M.; Baas, Paul

doi:10.1093/annonc/mdy424.075

Cited by 24 publications

(38 citation statements)

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“…All authors had full access to all of the data in the analyses, and the corresponding author had final responsibility for the decision to submit for publication. , and the estimated 4-year overall survival was 14% (95% CI 11-17; figure 1) The estimated 4-year overall survival was higher in patients with at least 1% PD-L1 expression (19% [95% CI [15][16][17][18][19][20][21][22][23][24]) than in those with less than 1% PD-L1 expression (11% [7][8][9][10][11][12][13][14][15][16]; appendix p 16), but was similar between patients with squamous and non-squamous tumour histology (appendix p 17). Baseline characteristics of nivolumab-treated patients who survived for at least 4 years are shown in the appendix (p 7).…”

Section: Role Of the Funding Sourcementioning

confidence: 97%

Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis

Antonia

Borghaei

Ramalingam

et al. 2019

The Lancet Oncology

285

243

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Background-Phase 3 clinical data has shown higher proportions of patients with objective response, longer response duration, and longer overall survival with nivolumab versus docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC). We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival. Methods-We pooled data from four clinical studies of nivolumab in patients with previously treated NSCLC (CheckMate 017, 057, 063, and 003) to evaluate survival outcomes. Trials of nivolumab in the second-line or later setting with at least 4 years follow-up were included. Comparisons of nivolumab versus docetaxel included all randomised patients from the phase 3 CheckMate 017 and 057 studies. We did landmark analyses by response status at 6 months to determine post-landmark survival outcomes. We excluded patients who did not have a radiographic tumour assessment at 6 months. Safety analyses included all patients who received at least one dose of nivolumab. Findings-Across all four studies, 4-year overall survival with nivolumab was 14% (95% CI 11-17) for all patients (n=664), 19% (15-24) for those with at least 1% PD-L1 expression, and 11% (7-16) for those with less than 1% PD-L1 expression. In CheckMate 017 and 057, 4-year overall survival was 14% (95% CI 11-18) in patients treated with nivolumab, compared with 5% (3-7) in patients treated with docetaxel. Survival subsequent to response at 6 months on nivolumab or docetaxel was longer than after progressive disease at 6 months, with hazard ratios for overall survival of 0•18 (95% 0•12-0•27) for nivolumab and 0•43 (0•29-0•65) for docetaxel; for stable disease versus progressive disease, hazard ratios were 0•52 (0•37-0•71) for nivolumab and 0•80 (0•61-1•04) for docetaxel. Long-term data did not show any new safety signals. Interpretation-Patients with advanced NSCLC treated with nivolumab achieved a greater duration of response compared with patients treated with docetaxel, which was associated with a long-term survival advantage. Funding-Bristol-Myers Squibb.

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Section: Role Of the Funding Sourcementioning

confidence: 97%

Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis

Antonia

Borghaei

Ramalingam

et al. 2019

The Lancet Oncology

285

243

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“…A fixed duration of 2 years of treatment vs. continuing ICI resulted in a similar 3-year survival in nivolumab and pembrolizumab treated patients, but number of patients reaching the 2 year of treatment was low (15,31,89). It is currently unclear whether re-challenge ICI in patients relapsing after ICI discontinuation is a good treatment strategy as results for pembrolizumab (79% of rechallenged patients had clinical benefit) and nivolumab (59% clinical benefit) are somewhat conflicting (88,89). Type of response is associated with outcome (responders have a better outcome than those with stable disease) (66), but in contrast to melanoma (suggested that in those with a complete response ICI can be stopped) (90), it is in NSCLC not clear whether type of response can be used in the decision whether to discontinue the ICI.…”

Section: Perspectivesmentioning

confidence: 98%

“…In contrast, in stage IV NSCLC the results of the CheckMate153 trial suggest that discontinuing treatment after 1 year results in a shorter survival compared to continuing nivolumab (88). A fixed duration of 2 years of treatment vs. continuing ICI resulted in a similar 3-year survival in nivolumab and pembrolizumab treated patients, but number of patients reaching the 2 year of treatment was low (15,31,89). It is currently unclear whether re-challenge ICI in patients relapsing after ICI discontinuation is a good treatment strategy as results for pembrolizumab (79% of rechallenged patients had clinical benefit) and nivolumab (59% clinical benefit) are somewhat conflicting (88,89).…”

Section: Perspectivesmentioning

confidence: 99%

Immunotherapy: From Advanced NSCLC to Early Stages, an Evolving Concept

et al. 2020

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Immunotherapy in lung cancer treatment is a long history paved with failures and some successes. During the last decade, the discovery of checkpoints inhibitors led to major advances in treating advanced and metastatic non-small cell lung cancer (NSCLC). Impressive data from early phase I-II studies were subsequently confirmed in large prospective randomized trials and meta-analyses (High-level of evidence). Three anti-programmed death-1 (PD1) (pembrolizumab, nivolumab) or antiPD-ligand(L)1 (atezolizumab) antibodies showed clinically significant improved survival compared to second-line docetaxel. Then, first-line pembrolizumab monotherapy demonstrated its superiority over platinum-doublet in high PD-L1 NSCLC. The addition of pembrolizumab or atezolizumab to chemotherapy derived the same results regardless of the PD-L1 status. On the opposite, antiCTLA4 (Cytotoxic T-Lymphocyte Associated 4) results are currently disappointing in unselected patients while recent development suggest that the combination of antiPD1 and antiCTLA4 (nivolumab-ipilimumab) positively impact on overall survival. Some secondary analyses also showed that immunotherapy has a positive impact on quality of life and that the clinical improvement can be done at an acceptable incremental cost per QALY. A lot of questions remain unresolved: which is the best treatment duration and is it the same for all patients, how to choose the patients that will have the highest benefit of immunotherapy, how to identify the patients who will have rapid progression, how to improve the current data (new targets, new combinations)…

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“…It was con rmed ~ as for surgically resectable non-small cell lung cancer, neoadjuvant immunotherapy, high safety does not affect surgery, and the pathological signi cant remission rate is 45%, and the 18-month relapse-free survival rate is 73% [33]. Studies have also shown that early non-small cell cancer administration of immune drugs to block multiple molecular tags can kill cancer cells with fewer side effects [34]. Therefore, in addition to the traditional treatment of lung cancer patients, taking immunotherapy can improve the survival rate of patients [35].…”

Section: A B 4 Discussionmentioning

confidence: 97%

Development of Prognostic Nomogram Based on Immune Scores in Lung Adenocarcinoma Patients

Xie¹,

Zhang²,

Li³

2020

Preprint

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Background: Immunotherapy has significantly altered the treatment landscape for non-small cell lung cancer (NSCLC).However, there is no report on the prediction of overall survival (OS) of lung adenocarcinoma (LDAC) based on immune score. In this study,we aim to investigate the immune scores of the LADC and the prognosis-related factors and construct a nomogram for prognosis prediction.Methods:A total of 407 cases were included in the study.And the clinicopathological characteristics of patients with LADC and immune scores were download from TCGA database.We used Cox proportional hazards regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).Nomograms were framed from Cox models and internally validated by use of 1000 bootstrap.Model discrimination was assessed by using the concordance index (c-index) and the calibration curve.Results：Patients were divided into groups with low, moderate, or high Subgroups based on immune scores.This study shows that compared with patients with low and intermediate immune scores, only those with high immune scores had significantly improved OS (HR and 95% confidence interval[CI]:0.488 [0.327‐0.730]).The C‐index for OS prediction was 0.707(95% CI, 0.664‐0.750) .The calibration curves for prediction of 3-years and 5-years OS probabilities demonstrated good calibration and discrimination.Conclusions：High immune scores Subgroup is very significantly correlated with better OS in patients with LADC. Moreover, the nomograms for predicting prognosis may help to assess the survival of patients with LADC.

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Long-term survival in patients (pts) with advanced NSCLC in the KEYNOTE-010 study overall and in pts who completed two years of pembrolizumab (pembro)

Cited by 24 publications

References 0 publications

Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis

Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis

Immunotherapy: From Advanced NSCLC to Early Stages, an Evolving Concept

Development of Prognostic Nomogram Based on Immune Scores in Lung Adenocarcinoma Patients

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