Safety analysis showed grade 3–4 treatment-related adverse events (TRAEs) in 47% of the immunotherapy plus chemotherapy arm versus 38% of the chemotherapy only arm, most commonly neutropenia (7 vs 9%), anaemia (6 vs 14%), diarrhoea (4 vs 1%), elevated liapse (6 vs 1%) and asthenia (1 vs 2%). “Notably, a survival benefit was observed across various patient subgroups, including populations with a high unmet medical need, such as those with CNS metastases”, report Luis Paz-Ares, from Hospital Universitario 12 de Octubre in Madrid, Spain, and co-workers in The Lancet Oncology. This compared with the median OS of 10.7 months achieved by the 358 patients who instead received four cycles of chemotherapy, giving a significant hazard ratio (HR) for death of 0.69 in favour of immunotherapy use.Īfter a further 3.5 months of median follow-up, median OS continued to be significantly better with immunotherapy plus chemotherapy than chemotherapy alone, at 15.6 versus 10.9 months and a HR of 0.66.įorest plot analysis of OS favoured the immunotherapy regimen across the prespecified subgroups, including by PD–L1 expression, with the exceptions of patients aged at least 75 years and never smokers. When combined with the combination’s “favourable risk–benefit profile”, the investigators say their “data support this regimen as a new first-line treatment option for patients with advanced NSCLC.”įollowing positive phase II study results, the researchers further investigated the hypothesis that use of chemotherapy could “provide rapid disease control” while the benefits of immunotherapy can take hold.Īt the prespecified interim analysis, after a median follow-up of 9.7 months, the primary endpoint of OS was a median 14.1 months for the 361 patients who were randomly assigned to receive nivolumab 360 mg every 3 weeks plus ipilimumab 1 mg/kg every 6 weeks, combined with two cycles of a histology-driven regimen of platinum-based doublet chemotherapy. ![]() ![]() MedwireNews: Use of nivolumab plus ipilimumab alongside chemotherapy significantly improved overall survival (OS) for treatment-naïve, stage IV or recurrent non-small-cell lung cancer (NSCLC) patients in the CheckMate 9LA trial compared with chemotherapy alone. Author: By Lynda Williams, Senior medwireNews Reporter
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