IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC

Spigel, David R.; Marinis, Filippo de; Giaccone, Giuseppe; Reinmuth, Niels; Vergnenègre, A.; Barrios, CH; Morise, Masahiro; Felip, Enriqueta; Andrić, Zoran; Geater, Sarayut Lucien; Özgüroǧlu, Mustafa; Mocci, Simonetta; McCleland, Mark L.; Enquist, Ida; Komatsubara, Kimberly M.; Deng, Yu; Kuriki, Hiroshi; Wen, Xiaohui; Jassem, Jacek; Herbst, Roy S.

doi:10.1093/annonc/mdz293

Cited by 132 publications

(118 citation statements)

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confidence: 62%

“…Similar findings were echoed by atezolizumab in IMpower 110, 9 where a benefit in terms of OS was again driven by high PD-L1 expressors. 9 In this trial, nearly 40% of the patients in both arms had a PD-L1 ≥50%. Unlike other trials in which the importance of high PD-L1 expression was known, the Checkmate 026 trial set a 5% cut-off for PD-L1 and did not stratify for PD-L1 ≥50%.…”

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confidence: 62%

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Tracking the tail

Friedlaender¹,

Liu

Addeo³

2020

J Immunother Cancer

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Immune-checkpoint inhibitors have deeply changed the therapeutic landscape of advanced non-small cell lung cancer without actionable genomic alterations. Immune-checkpoint inhibitors have become standard front-line therapy, especially among patients with tumours expressing high levels of programmed death ligand-1; yet, many patients do not respond to therapy. This has led to the adoption of front-line combination therapies, administering programmed death-1 inhibitors concomitantly either with other checkpoint inhibitors, chemotherapy or both. Today’s approved standard of care includes options with chemoimmunotherapy or dual checkpoint blockade, but each combination has only been compared to chemotherapy alone and no head-to-head trials exist. In cross-trial comparisons, combinations trials appear to show numerically superior responses to single-agent checkpoint inhibitors but the question is whether they ultimately offer a survival advantage. In this manuscript, we summarize and analyse all currently available front-line immune-checkpoint inhibitor trials in non-small cell lung cancer, whether as monotherapy or in combination with chemotherapy, second immunotherapy agents or both. Should standards of care change given the current data? While we ponder this question, we illustrate current data and conclude that the answer lies in tracking the tail of the survival curves.

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supporting

confidence: 62%

supporting

confidence: 62%

Tracking the tail

Friedlaender¹,

Liu

Addeo³

2020

J Immunother Cancer

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“…The three year follow-up in the Keynote 024 trial shows a significant overall survival (OS) benefit, with a median OS of 26.3 months in the pembrolizumab group compared to 14.2 months in the chemotherapy group [14]. These results were recently mirrored with atezolizumab, an anti-PD-L1 antibody [15]. Unfortunately, none of the trials include patients with a PS of 2.…”

Section: Introductionmentioning

confidence: 99%

Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab

et al. 2020

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Objectives: We retrospectively analysed patients with advanced non-small-cell lung cancer (NSCLC) harbouring high PD-L1 expression (>50%) and treated with front-line pembrolizumab, comparing outcomes of patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 to those with PS 0-1. Methods: Data were collected by 16 participating centres. All patients with NSCLC and high PD-L1, treated with first-line pembrolizumab were included. We collected medical data from patient files, pathology and laboratory reports. Patient characteristics, comorbidities, PS, and tumour characteristics were reported. Overall survival (OS), progression-free survival (PFS) and response rate (RR) were calculated. Results: 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. Median OS was 7.8 months (95% CI: 2.5-10.7) in the PS2 group, not reached in the PS 0-1 group. PS 2 remained predictive of poor outcomes in multivariate analysis. Conclusion: PS 2 is a strong independent predictor of poor response and survival in NSCLC patients with high PD-L1, treated with front-line pembrolizumab. Prospective randomised trials comparing immunotherapy to chemotherapy in this population would be welcome.

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“…Nivolumab plus ipilimumab is now approved in the US for first-line treatment of PD-L1-expressing NSCLC [12]. Based on interim results from the Phase III Impower110 trial [17], atezolizumab monotherapy has also been granted US approval for first-line treatment of NSCLC tumors with high PD-L1 expression [18]. Recent clinical practice guidelines recommend these immunotherapies as first-line treatment options in line with regulatory approvals and/or Phase III trial data [5].…”

Section: Introductionmentioning

confidence: 99%

Non-interventional LUME-BioNIS study of nintedanib plus docetaxel after chemotherapy in adenocarcinoma non-small cell lung cancer: A subgroup analysis in patients with prior immunotherapy

et al. 2020

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To evaluate the effectiveness and safety of nintedanib plus docetaxel in patients with advanced adenocarcinoma non-small cell lung cancer (NSCLC) previously treated with both chemo-and immunotherapy. Materials and methods: LUME-BioNIS is a European, prospective, multicenter, non-interventional study of patients with advanced adenocarcinoma NSCLC, who initiated nintedanib plus docetaxel after first-line chemotherapy in routine practice according to the approved nintedanib EU label. The primary objective is to explore whether molecular biomarkers can predict overall survival (OS). Information on clinical or radiologic progression and death, and adverse drug reactions (ADRs)/fatal adverse events (AEs) was collected during follow-up. Here, we report a subgroup analysis evaluating outcomes in immunotherapy-pretreated patients. Results: Of 260 enrolled patients, 67 (25.8%) had prior immunotherapy and were included in this subgroup analysis. Prior immunotherapy was administered in first-line in 20 patients (29.9%; combined with chemotherapy in 4 patients [6.0%]) and later-lines in 47 patients (70.1%), and most commonly comprised nivolumab (39 patients; 58.2%), atezolizumab (14 patients; 20.9%) and pembrolizumab (11 patients; 16.4%). Nintedanib plus docetaxel was given in second-line in 10 patients (14.9%) and in later-lines in 57 patients (85.1%). Median OS was 8.8 months (95% confidence interval [CI]: 7.0-11.5) and median progression-free survival (PFS) was 4.6 months (95% CI: 3.5-5.7). Among 55 patients with available data, rates of objective response and disease control were 18.2% and 78.2%, respectively. In 65 patients evaluable for safety, the most common on-treatment ADRs/ AEs were malignant neoplasm progression (19 patients; 29.2%), diarrhea (21 patients; 32.3%) and nausea (10 patients; 15.4%). Conclusions: Used according to the approved nintedanib label in routine practice, nintedanib plus docetaxel demonstrated clinical effectiveness, with no unexpected safety findings, in patients with prior chemotherapy and

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IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC

Cited by 132 publications

References 0 publications

Tracking the tail

Tracking the tail

Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab

Non-interventional LUME-BioNIS study of nintedanib plus docetaxel after chemotherapy in adenocarcinoma non-small cell lung cancer: A subgroup analysis in patients with prior immunotherapy

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