ASCO 2018: Safety Analysis of First-Line Nivolumab Plus Ipilimumab for Advanced NSCLC
Posted: Friday, June 29, 2018
Nivolumab plus ipilimumab seems to be well tolerated as a first-line treatment among patients with advanced non–small cell lung cancer (NSCLC), according to an updated safety analysis and patient-reported outcomes from Checkmate 227, a phase III study led by Martin Reck, MD, PhD, of Lung Clinic Grosshansdorf, Germany. Toxicities were reported to be manageable using previously established treatments, including corticosteroids. These results were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9020).
Eligible patients (n = 1,739) had stage IV recurrent NSCLC without known EGFR or ALK mutations and no prior chemotherapy treatment. The investigators randomized patients 1:1:1 to three arms. Patients with greater than or equal to 1% tumor PD-L1 expression were treated with nivolumab plus ipilimumab, nivolumab monotherapy, or chemotherapy. Those with less than 1% tumor PD-L1 expression were randomly assigned to receive nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy.
The median duration of therapy was 4.2 months for patients treated with the combination therapy versus 2.6 months for patients treated with chemotherapy alone. The rate of any grade treatment-related adverse event was 75% in the nivolumab-plus-ipilimumab group versus 81% for those receiving chemotherapy. Severe adverse events occurred in 36% and 31% of patients, respectively. Frequent grade 3 or 4 adverse events in patients receiving the combination therapy were hepatic (8%), gastrointestinal (3%), endocrine (3%), and skin (3%).
The authors noted that more detailed future analyses may help inform the management of immune-related adverse events.
