Less Frequent Dosing of Nivolumab in NSCLC
Posted: Wednesday, April 3, 2019
Patients with non–small cell lung cancer (NSCLC) experienced similar efficacy and safety results when taking 4- versus 2-week regimens of nivolumab, according to the interim analysis of the CheckMate 384 trial, presented at the 2019 American Society of Clinical Oncology–Society for Immunotherapy of Cancer (ASCO-SITC) Clinical Immuno-Oncology Symposium (Abstract 100) in San Francisco. Edward B. Garon, MD, of David Geffen School of Medicine, University of California, Los Angeles, and colleagues suggest these findings may support a more convenient dosing option in the second-line treatment setting.
Researchers conducted an international, open-label randomized phase IIIb/IV trial in 329 patients with advanced NSCLC who had received prior treatment with nivolumab every 2 weeks for up to 12 months. Patients were randomly assigned to receive a 30-minute infusion of nivolumab at 480 mg every 4 weeks (166 patients) or 240 mg every 2 weeks (163 patients).
Patients on the 4-week regimen had a similar progression-free survival as patients on the 2-week regimen (12.1 months vs. 12.2 months, respectively). The safety profile was also similar, with 48% of the 4-week regimen group reporting any-grade treatment-related adverse events (vs. 61% of the 2-week regimen group). Also, 6% of the 4-week group reported any-grade treatment-related adverse events that led to therapy discontinuation (vs. 9% of the other group). No treatment-related deaths were reported in either group.
In the United States and Canada, nivolumab is approved at 240 mg every 2 weeks or 480 mg every 4 weeks, in the second-line treatment of patients with advanced NSCLC. A final analysis is planned once all study participants have at least 12 months of follow-up.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
