Georgina V. Long, BSc, PhD, MBBS, FRACP, discusses the long-term data from the phase II ABC study , in which investigators are comparing the efficacy of nivolumab in combination with ipilimumab versus single-agent nivolumab in patients with melanoma brain metastases.
Georgina V. Long, BSc, PhD, MBBS, FRACP, co-medical director of Melanoma Institute Australia (MIA), chair of Melanoma Medical Oncology and Translational Research at MIA and Royal North Shore Hospital, University of Sydney, discusses the long-term data from the phase II ABC study (NCT02374242), in which investigators are comparing the efficacy of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) versus single-agent nivolumab in patients with melanoma brain metastases.
For the trial, patients with asymptomatic brain metastases with no prior local brain treatment were randomized to either cohort A or cohort B. Patients in cohort A received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks with a maximum of 4 doses, then nivolumab 3 mg/kg every 2 weeks. Those in cohort B were given nivolumab 3 mg/kg every 2 weeks. Patients in cohort C had brain metastases, failed local therapy, had neurological symptoms, and/or had leptomeningeal disease, received nivolumab 3 mg/kg every 2 weeks. Prior treatment with a BRAF inhibitor was permitted.
When patients who were previously treated with BRAF or MEK inhibitors were excluded, response rates were much higher at 59% with the combination immunotherapy versus 21% with nivolumab monotherapy, says Long. Of the 8 patients who had received prior treatment with BRAF or MEK inhibitors, only 2 responded to the combination immunotherapy regimen. As such, the take-home message is that the combination of nivolumab plus ipilimumab is highly active in patients with multiple untreated asymptomatic melanoma brain metastases, but efficacy diminishes if patients had prior treatment with BRAF or MEK inhibitors, she concludes.