The following article features coverage from the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

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.


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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.

RELATED: Q&A With Keith Flaherty, MD: Dabrafenib and Trametinib for Melanoma

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.

Reference

  1. 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).