Table 3 Summary of efficacy endpoints

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 = 111)

Best overall response, n (%)

CR

1 (0.9)

PR

88 (79.3)

SD

9 (8.1)

PD

11 (9.9)

NE

2 (1.8)

ORR, %

80.2

95% CI

71.5, 87.1

DOR, months

Median

20.3

95% CI

11.0, 26.1

DCR, %

88.3

95% CI

80.8, 93.6

PFS, months

Median

16.5

95% CI

10.2, 27.0

3 months, % (95% CI)

89.8 (82.4, 94.2)

6 months, % (95% CI)

83.2 (74.6, 89.0)

12 months, % (95% CI)

53.8 (42.7, 63.6)

  1. Responses were evaluated per RECIST version 1.1. The Clopper–Pearson method was used for 95% CI. PFS was calculated using the Kaplan–Meier method
  2. CR complete response, DCR disease control rate, 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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