Pooled long-term data from the phase 3 CheckMate-017 and CheckMate-057 studies showed that treatment with nivolumab was associated with a 5-fold increase in overall survival compared with chemotherapy, in patients with previously treated non-small cell lung cancer (NSCLC). Study findings were presented by Dr Scott Gettinger of Yale Comprehensive Cancer Center at the IASLC 2019 World Conference on Lung Cancer.
The CheckMate-017 and CheckMate-057 studies evaluated the overall survival of nivolumab compared with docetaxel in 854 patients with advanced NSCLC, ECOG performance status 0 to 1, and progression during or after first-line platinum-based chemotherapy. Patients were randomized 1:1 to receive nivolumab 3mg/kg intravenous (IV) once every 2 weeks or docetaxel 75mg/m2 IV once every 3 weeks until disease progression or unacceptable toxicity. After completion of the primary analysis, patients in the docetaxel arm could cross over to receive nivolumab if they were no longer receiving benefit. The primary end point for both studies was overall survival.
Results showed that at 5-year follow up, 50 nivolumab patients and 9 docetaxel patients were alive. Overall survival rates at 5 years were 13.4% for nivolumab and 2.6% for docetaxel; progression-free survival rates were 8% and 0%, respectively. Moreover, nivolumab demonstrated an overall survival benefit across subgroups, including patients with tumor PD-L1 expression <1%, compared with docetaxel.
Regarding safety, no new treatment-emergent adverse events were seen with nivolumab. The most common adverse events with a potential immunological cause were related to skin, in 13% of patients, none of which were grade 3 or 4.
“CheckMate 017 and 057 are the first phase 3 trials to report 5-year outcomes for a PD-1 inhibitor in previously treated advanced NSCLC, demonstrating a greater than 5-fold increase in 5-year OS rates with nivolumab (13.4%) compared with docetaxel (2.6%). Nivolumab remained well tolerated with no new safety signals,” according to Dr Gettinger.
Nivolumab (Opdivo; Bristol-Myers Squibb) is a human programmed death receptor-1 (PD-1)-blocking antibody. It is currently indicated to treat HCC in patients previously treated with sorafenib, lung cancer, head and neck cancer, renal cancer, urothelial cancer, colorectal cancer, lymphoma, and melanoma.
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