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First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): An international, randomised, open-label, phase 3 trial

The Lancet Oncology Jan 22, 2021

Paz-Ares L, Ciuleanu TE, Cobo M, et al. - Given that improved overall survival with first-line nivolumab plus ipilimumab has been observed in patients suffering from advanced non-small-cell lung cancer (NSCLC), researchers conducted this randomized, open-label, phase 3 trial to determine if the clinical benefit would be further enhanced by adding a limited course (two cycles) of chemotherapy to this combination. Eligible patients were randomized (1:1) to nivolumab (360 mg intravenously every 3 weeks) plus ipilimumab (1 mg/kg intravenously every 6 weeks) combined with histology-based, platinum doublet chemotherapy (intravenously every 3 weeks for two cycles; experimental group), or chemotherapy alone (every 3 weeks for four cycles; control group). There were 1,150 patients enrolled, with 719 (62·5%) randomly assigned to nivolumab plus ipilimumab with two cycles of chemotherapy (n=361 [50%]) or four cycles of chemotherapy alone (n=358 [50%]). Overall survival in all randomized patients was significantly longer in the experimental group vs the control group (median 14.1 months vs 10.7 months) at the pre-planned interim analysis. Median overall survival was 15.6 months in the experimental group vs 10.9 months in the control group, with 3.5 months longer median follow-up.  According to findings, not only a favorable risk–benefit profile but also a significant improvement in overall survival was conferred by nivolumab plus ipilimumab with two cycles of chemotherapy when compared with chemotherapy alone. In light of these observations, this regimen was supported as a new first-line therapy choice for patients suffering from advanced NSCLC.

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