![]() Of note, the tolerability of nivolumab in older patients aged 70 years and above and those with a poor performance status was comparable to that in the overall population. In this open-label study – the results of which were presented at the 2017 ESMO Congress – no new safety signals were observed with nivolumab monotherapy. Patient population: Previously treated stage IIIB/IV squamous NSCLC Related news story: No PFS advantage with nivolumab in advanced NSCLC patients selected by PD-L1 expression CheckMate 171: Ongoing Overall survival was also comparable, but nivolumab had better tolerability. Patient population: Treatment-naïve stage IV or recurrent NSCLC with ≥1% PD-L1-positive tumor cellsĬomparator: Investigator’s choice of platinum-based chemotherapyĪs reported in The New England Journal of Medicine in June 2017, nivolumab treatment did not significantly prolong the primary endpoint of PFS relative to chemotherapy in the primary efficacy analysis population of patients with a PD-L1 expression level of at least 5%. Related news story: First-line nivolumab promising in advanced NSCLC CheckMate 026: Ongoing In December 2016, The Lancet Oncology published a report on the subcohort of patients with previously untreated disease who were given nivolumab alongside the CTLA-4 inhibitor ipilimumab at a dose of 1 mg/kg every 6 or 12 weeks, with high response rates and durable responses in both groups. The second set of results showed that nivolumab could be combined with standard platinum-based doublet chemotherapy in the first line to promising effect, although discontinuation as a result of toxicities tended to be greater than would be expected with either nivolumab or chemotherapy alone. Two sets of results from this study were published in the Journal of Clinical Oncology in June 2016, with the first showing durable responses and a tolerable safety profile with nivolumab monotherapy in treatment-naïve patients. This multicohort study is evaluating the safety and efficacy of nivolumab, at a range of doses, as first-line or maintenance therapy, alone and in combination with other regimens. Similar to CheckMate 017, nivolumab was associated with improved HRQoL, as reported in the European Journal of Cancer in August 2018.Īdditionally, researchers have pooled data from CheckMate 057 and 017, and reported the 2- and 3-year outcomes (in the Journal of Clinical Oncology and Annals of Oncology, respectively), showing sustained OS improvement with the PD-1 inhibitor versus the taxane. The response rate was also higher with nivolumab, but PFS was longer with docetaxel. ![]() Treatment with nivolumab significantly prolonged OS relative to docetaxel in patients who had progressed during or after platinum-based chemotherapy, according to the report published in The New England Journal of Medicine in October 2015. Patient population: Previously treated stage IIIB/IV or recurrent nonsquamous NSCLC Nivolumab offers durable survival benefits in advanced NSCLC.Nivolumab vs docetaxel updated results for nonsquamous, squamous NSCLC.CheckMate for nivolumab in untreated melanoma, squamous NSCLC.Around 15% of study participants achieved an objective response, the median duration of which had not been reached at the time of analysis. This single-arm study showed that nivolumab was active in patients who had received at least two prior lines of therapy and had a manageable safety profile. Patient population: Previously treated advanced or metastatic squamous NSCLC The drug manufacturer Bristol-Myers Squibb (New York, USA) is the main sponsor of all trials and the nivolumab dose used in the trials is 3 mg/kg given every 2 weeks as an intravenous infusion unless otherwise specified. For trials consisting of multiple solid tumor cohorts, we focus on just the NSCLC and SCLC cohorts in this guide. Here we round up the 21 trials focusing on non-small-cell lung cancer (NSCLC) and the three small-cell lung cancer (SCLC) trials, with top-line results outlined where available. Nivolumab – an anti-PD-1 agent – is being evaluated in the CheckMate trials for the treatment of various malignancies, either as a single agent or in combination with the CTLA-4 inhibitor ipilimumab.
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