CheckMate 057 Update Supports Nivolumab Over Docetaxel for NonSquamous NSCLC

Nivolumab is superior to docetaxel for overall survival after 18 months of follow-up in patients with nonsquamous non-small-cell lung cancer

medwireNews: Updated CheckMate 057 results favouring nivolumab over docetaxel for most patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) were reported this week at the European Cancer Congress in Vienna, Austria.

Leora Horn, from Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, USA, presented at the European Cancer Congress in Vienna, Austria, the 18-month subgroup analysis and patient-reported outcomes (PROs) from the trial of patients with stage III or IV nonsquamous NSCLC who were randomly assigned to receive programmed cell death protein 1 (PD-1) inhibitor (n=292) or chemotherapy (n=290).

Overall survival (OS) was previously reported at 12 months and showed a significant benefit for nivolumab over docetaxel, at a median 12.2 versus 9.4 months and a 1-year OS rate of 51% versus 39%. At the 18-month update, the median OS was unchanged but the 18-month OS rate was 39% in the nivolumab-treated patients versus 23% for the docetaxel group, giving a significant hazard ratio of 0.72.

Moreover, the overall response rates in the nivolumab and docetaxel groups were 19% versus 12% with a median duration of response of 17.2 versus 5.6 months.

Discussing patient subgroups, including those based on age, gender and baseline ECOG status, Leora Horn commented: “[F]or the majority of patients, the response rate favoured nivolumab with the exception of never smokers, where response rates were 15% for patients treated with docetaxel compared to 9% for nivolumab, and for patients with EGFR-positive disease, where response rates are 16% for docetaxel and 11% for nivolumab.”

And the updated analysis continued to show a significant difference in overall survival when patients were stratified by programed death-ligand 1 (PD-L1) expression, she reported, with greater OS, progression-free survival and objective response rate results in patients whose PD-L1 expression met the thresholds of 1% or above, 5% or above and 10% or above than those with lower levels.

Moreover, the PROs, as measured on the Lung Cancer Symptom Scale, showed the average symptom burden index improvement was similar in the nivolumab and docetaxel treatment groups at 12 weeks (17.8 vs 19.7%) and stable over time for both treatment groups.

And nivolumab-treated patients had a lower rate of grade 3 and 4 serious treatment-related adverse events than docetaxel-treated patients (5 vs 18%) and fewer adverse events of this grade that led to discontinuation (4 vs 7%); adverse event rates were independent of PD-L1 expression.

“Although there was no difference in overall survival between nivolumab and docetaxel among patients whose tumors did not express PD-L1, the improved safety profile and durability of responses to nivolumab suggest that it might be a reasonable option for patients regardless of PD-L1 expression”, Leora Horn and co-workers write in The New England Journal of Medicine, where the results were simultaneously reported.

The researchers add that while progression-free survival was not statistically superior for nivolumab versus docetaxel, the curves crossed at 1 year, at a rate of 19% versus 8%, which they believe may represent “a delay in benefit with nivolumab that may be typical with immunotherapy”.


Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cáncer. N Engl J Med 2015; Advance online publication 27 September. DOI: 10.1056/NEJMoa1507643

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