Table 3.
Best Overall Intracranial Response per BIRC Assessment
| Parameter | Ceritinib 750 mg N = 25 | Chemotherapy N = 22 |
|---|---|---|
| OIRR, n (%) [95% CI] | 11 (44.0) [24.4–65.1] | 5 (22.7) [7.8–45.4] |
| BOIR, n (%) | ||
| CR | 7 (28.0) | 2 (9.1) |
| PR | 4 (16.0) | 3 (13.6) |
| Stable disease | 0 | 2 (9.1) |
| PD | 3 (12.0) | 1 (4.5) |
| Non-CR or non-PD | 9 (36.0) | 10 (45.5) |
| Unknown | 2 (8.0) | 4 (18.2) |
| IDCR, n (%) [95% CI] | 20 (80.0) [59.3–93.2] | 17 (77.3) [54.6–92.2] |
Note: N is the total number of patients with measurable and/or nonmeasurable disease in the brain at baseline as per BIRC neuroradiology review. It is the denominator for percentage calculation. The n is the number of patients who are in the corresponding category. OIRR is CR plus PR. IDCR is CR plus PR plus stable disease plus non-CR or non-PD. Non-CR or non-PD refers to BOIRs that are neither CR nor PD per the modified RECIST v1.1 criteria for patients with nonmeasurable disease only at baseline.
BIRC, Blinded Independent Review Committee; BOIR, best overall intracranial response; CI, confidence interval; CR, complete response; IDCR, intracranial disease control rate; OIRR, overall intracranial response rate; PD, progressive disease; PR, partial response; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1.