Immunotherapy Shows Promise in Patients With Melanoma Brain Metastases
Nivolumab alone or in combination with ipilimumab were reported to show activity in patients with melanoma and asymptomatic brain metastases.
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Nivolumab alone or in combination with ipilimumab were reported to show activity in patients with melanoma and asymptomatic brain metastases (mets), according to data from the Anti-PD1 Brain Collaboration (ABC) study presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
The Australian investigator-led study was presented by Georgina V, Long, MD, chair of melanoma medical oncology & translational research at the University of Sydney in Australia.
Between 20% and 25% of patients with stage IV melanoma have brain mets at diagnosis. The ABC study was an open-label, phase 2 study that enrolled 3 cohorts of patients (76) with melanoma and brain mets.
Cohorts A (33 patients) and B (27 patients) enrolled patients with asymptomatic brain mets with no prior local brain therapy. Patients in cohort A received induction therapy with the combination of nivolumab (1 mg/kg) and ipilimumab (3 mg/kg) every 3 weeks for 4 cycles and then nivolumab 3 mg/kg every 3 weeks. Patients in cohort B received nivolumab 3 mg/kg every 2 weeks.
Patients in cohort C (16) had brain mets that had failed local therapy and had neurologic symptomatic brain mets with leptomeningeal disease.
The data cut-off (May 8, 2017) included 67 patients (Cohort A: 26 patients; Cohort B: 25 patients; Cohort C: 16 patients) who were on the study drug for more than 16 weeks. Median follow up was 16.4 months.
The primary endpoint of intracranial response was reported for 42%, 20%, and 6% of patients in cohorts A, B, and C, respectively, with complete responses reported for 15%, 12% and 0% of patients. For treatment-naïve patients, intracranial responses were 50%, 21%, and 25% of patients in cohorts A, B, and C, respectively.
Best extracranial responses were 48%, 30%, and 25% for patients in cohorts A, B, and C, respectively.
Intracranial median progression-free survival (PFS) was 4.8, 2.7, and 2.5 months for patients in cohorts A, B, and C, respectively; the corresponding 6-month PFS was 46%, 28%, and 13%, respectively.
Extracranial median PFS was 5.3, 2.7, and 2.7 months for patients in cohorts A, B, and C, respectively; the corresponding 6-month PFS was 47%, 40%, and 10%, respectively.
Treatment-related grade 3 to 4 toxicity was seen in 46%, 24%, and 19% of patients in cohorts A, B, and C, respectively.
“Nivolumab combined with ipilimumab may be considered as upfront therapy in melanoma brain metastases,” Dr Long said.
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The investigators concluded, however, that “[patients] with symptomatic brain mets, leptomeningeal mets, or previous local therapy responded poorly to [nivolumab] alone.”
Read more of Cancer Therapy Advisor's coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.
- Long GV, Atkinson V, Menzies AM, et al. A randomized phase II study of nivolumab or nivolumab combined with ipilimumab in patients (pts) with melanoma brain metastases (mets): The Anti-PD1 Brain Collaboration (ABC). J Clin Oncol. 2017;34(suppl; abstr 9508).