Table 4 Intracranial ORR, DCR, and PFS by independent review committee among patients with intracranial target lesions at baseline

From: Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial

Efficacy

Efficacy-evaluable patients (N = 11)

Best overall response, n (%)

CR

1 (9.1)

PR

7 (63.6)

SD

2 (18.2)

PD

0 (0.0)

NE

1 (9.1)

ORR, %

72.7

95% CI

39.0, 94.0

DCR, %

90.9

95% CI

58.7, 99.8

PFS, months

Median

10.1

95% CI

1.4, 27.0

3 months % (95% CI)

81.8 (44.7, 95.1)

6 months, % (95% CI)

71.6 (35.0, 89.9)

12 months, % (95% CI)

30.7 (7.3, 58.6)

  1. Intracranial responses were assessed by the independent review committee per RANO-BM
  2. The Clopper–Pearson method was used for 95% CI
  3. PFS was calculated using the Kaplan–Meier method
  4. CR complete response, DCR disease control rate, DOR duration of response, NE not evaluable, ORR objective response rate, PD progressive disease, PR partial response, SD stable disease, PFS progression free survival, CI confidence interval
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