Survival of U.S. Medicare patients with advanced non-small cell lung cancer by line of therapy.

Summary Background Patients with squamous non-small-cell lung cancer that is refractory to multiple treatments have poor outcomes. We assessed the activity of nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for patients with advanced, refractory, squamous non-small-cell lung cancer. Methods We did this phase 2, single-arm trial at 27 sites (academic, hospital, and private cancer centres) in France, Germany, Italy, and USA. Patients who had received two or more previous treatments received intravenous nivolumab (3 mg/kg) every 2 weeks until progression or unacceptable toxic effects. The primary endpoint was the proportion of patients with a confirmed objective response as assessed by an independent radiology review committee. We included all treated patients in the analyses. This study is registered with ClinicalTrials.gov, number NCT01721759. Findings Between Nov 16, 2012, and July 22, 2013, we enrolled and treated 117 patients. 17 (14·5%, 95% CI 8·7–22·2) of 117 patients had an objective response as assessed by an independent radiology review committee. Median time to response was 3·3 months (IQR 2·2–4·8), and median duration of response was not reached (95% CI 8·31–not applicable); 13 (77%) of 17 of responses were ongoing at the time of analysis. 30 (26%) of 117 patients had stable disease (median duration 6·0 months, 95% CI 4·7–10·9). 20 (17%) of 117 patients reported grade 3–4 treatment-related adverse events, including: fatigue (five [4%] of 117 patients), pneumonitis (four [3%]), and diarrhoea (three [3%]). There were two treatment-associated deaths caused by pneumonia and ischaemic stroke that occurred in patients with multiple comorbidities in the setting of progressive disease. Interpretation Nivolumab has clinically meaningful activity and a manageable safety profile in previously treated patients with advanced, refractory, squamous non-small cell lung cancer. These data support the assessment of nivolumab in randomised, controlled, phase 3 studies of first-line and second-line treatment. Funding Bristol-Myers Squibb.

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“…Patient selection was not based on estimated survival; typical median survival in this population is 4·0–6·5 months. 12–14 …”

Section: Methodsmentioning

confidence: 99%

“…9–11 Prognosis for refractory squamous non-small-cell lung cancer is very poor, with median overall survival of between 4·0–6·5 months, 1-year survival of 6–18%, and 2-year survival of 3%. 12–14 …”

Section: Introductionmentioning

confidence: 99%

Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial

Rizvi

Mazières

Planchard

et al. 2015

The Lancet Oncology

1,273

917

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“…The median OS was 8 months (median follow-up: 8; range 0-17 months), and 1-year survival rate was 41%. Historically, the expected ORR for third-line treatment in patients with squamous cell NSCLC is approximately 2%, and 1-year survival rate is 6-18% [33,34]. Grade 3-4 drugrelated AEs were reported in 17% of patients and included fatigue (4%), pneumonitis (4%) and diarrhea (3%).…”

Section: Clinical Efficacymentioning

confidence: 98%

Nivolumab: Targeting PD-1 to Bolster Antitumor Immunity

2015

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Nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, blocks PD-1 and can restore anticancer immune responses by abrogating PD-1 pathway-mediated T-cell inhibition. Nivolumab is approved in Japan and the USA for the treatment of patients with advanced melanoma. A Phase I trial reported overall objective response rates of 17, 32 and 29% in patients with advanced non-small-cell lung cancer, melanoma and renal cell carcinoma, respectively, which included many heavily pretreated patients. 1-/2-year overall survival rates were 42%/24%, 63%/48% and 70%/50% for non-small-cell lung cancer, melanoma and renal cell carcinoma, respectively. Nivolumab significantly improved survival versus dacarbazine in previously untreated patients with metastatic melanoma in a Phase III trial. Nivolumab is associated with a manageable adverse event profile. Numerous clinical trials are investigating nivolumab alone or in combination with other therapies in multiple cancer settings. This article summarizes the development of nivolumab as of November 2014.

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“…Chez les patientes ayant un cancer du sein avec atteinte ganglionnaire, une chimiothérapie dose-dense à base de EC et P améliore significativement la DFS et l'OS à cinq ans, au prix d'une augmentation modérée des toxicités, confirmant ainsi les résultats obtenus dans les méta-analyses récentes [2,3]. Toutefois, la part du bénéfice observé lié à l'EC dose-dense de celui connu lié au P dose-dense [4,5] n'est pas élucidée.…”

Section: Commentaires Et Conclusionunclassified

“…Quatre-vingt-cinq pour cent sont des cancers non à petites cellules, dont un tiers sont des épidermoïdes. Le pronostic des patients ayant un carcinome épidermoïde réfractaire est sombre, avec une médiane de survie de 4 à 6,5 mois, et une survie à un an de 6 à 18 % [2]. Le traitement standard des carcinomes épi-dermoïdes reste la chimiothérapie, les avancées récentes sur les thérapies ciblées concernant essentiellement les adénocarcinomes pulmonaires.…”

Section: Activity and Safety Of Nivolumab An Anti-pd-1 Immune Checkpunclassified

AERIO news in brief

Cochereau¹,

Delaloge

Colle³

et al. 2015

Oncologie

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Survival of U.S. Medicare patients with advanced non-small cell lung cancer by line of therapy.

Cited by 14 publications

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Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial

Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial

Nivolumab: Targeting PD-1 to Bolster Antitumor Immunity

AERIO news in brief

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