. Author manuscript; available in PMC: 2023 Dec 1.

Published in final edited form as: Clin Cancer Res. 2023 Jun 1;29(11):2020–2024. doi: 10.1158/1078-0432.CCR-22-2400

Table 3:

Efficacy Results

EFFICACY PARAMETER	RIPRETINIB (N = 85)	PLACEBO (N = 44)	P-VALUE	HR (95% CI)
PROGRESSION FREE SURVIVAL [MEDIAN, MONTHS (95% CI)]	6.3 (4.6-6.9)	1.0 (0.9-1.7)	<0.0001^a	0.15 (0.09-0.25)
OBJECTIVE RESPONSE RATE [% (95% CI)]	9.4^b (4.2-17.7)	0	0.0504^c	n/a
OVERALL SURVIVAL [MEDIAN, MONTHS (95% CI)]	15.1 (12.3-15.1)	6.6 (4.1-11.6)	n/a	0.36 (0.21-0.62)

Source: FDA Analysis

^a–

p-value is based on 2-sided stratified log rank test

^b–

8 patients had a partial response

^c–

p-value is based on Fisher’s exact test

Abbreviations: HR: Hazard Ratio, CI: Confidence Interval, n/a: Not applicable