Intracranial response rate to ipilimumab–nivolumab (I–N)
| Intracranial response, no. (%) | First-line I–N (n=16) | Second-line and third-line I–N (n=21) | P value |
| Complete response | 5 (31.3) | 0 (0.0) | |
| Partial response | 7 (43.8) | 1 (4.8) | |
| Stable disease | 0 (0.0) | 0 (0.0) | |
| Progressive disease | 4 (25.0) | 20 (96.2) | |
| Disease control rate | 13 (81.2) | 1 (4.8) | <0.0001 |
| Objective response rate | 12 (75.0) | 1 (4.8) |
Assessments as per modified intracranial RECIST using gadolinium enhanced thin slice MRI for patients with at least one non-irradiated melanoma brain metastasis (MBM). For the first-line ipilimumab-nivolumab (I-N) group, 9 out of 25 patients were excluded from response evaluation as they had a solitary MBM that was treated with stereotactic radiosurgery within 12 weeks of commencement of I–N (n=5), whole brain radiotherapy within 12 weeks of commencement I–N (n=3) and did not have measurable intracranial lesions (n=1). In the second/third line I–N group, 9 out of 30 patients were excluded from response evaluation as they received whole brain radiotherapy within 12 weeks of commencement of I–N (n=5) and non-measurable MBMs (n=2), stereotactic radiosurgery to solitary MBM within 12 weeks of commencement of ipilimumab–nivolumab (n=2). Patients who were excluded for objective response assessment were included in the intracranial progression-free survival analysis.
RECIST, Response Evaluation Criteria in Solid Tumours.