Table 3.

OS and PFS in RECOURSE by KRAS status overall and in geographical subregions (ITT population).

ITT	USA		EU		Japan		Overall
	FTD/TPI	Placebo	FTD/TPI	Placebo	FTD/TPI	Placebo	FTD/TPI	Placebo
Wild-type KRAS, n	35	17	123	68	94	40	262	131
Median OS, months	6.7	4.3	8.8	5.5	9.0	6.8	8.0	5.7
OS HR (95% CI)	0.44 (0.22–0.87)		0.56 (0.38–0.81)		0.65 (0.44–0.96)		0.58 (0.45–0.74)
P value	0.0152		0.0019		0.0309		<0.0001
Median PFS, months	2.8	1.7	2.0	1.7	2.1	1.8	2.1	1.7
PFS HR (95% CI)	0.51 (0.26–1.02)		0.40 (0.28–0.56)		0.58 (0.39–0.84)		0.48 (0.38–0.60)
P value	0.0533		<0.0001		0.0041		0.0001
Mutant KRAS, n	29	18	148	64	84	48	272	135
Median OS, months	6.3	4.2	6.0	4.7	7.1	6.2	6.5	4.9
OS HR (95% CI)	0.77 (0.35–1.70)		0.68 (0.48–0.97)		0.87 (0.59–1.28)		0.80 (0.63–1.02)
P value	0.5209		0.0345		0.4730		0.0712
Median PFS, months	3.1	1.7	1.9	1.8	1.9	1.8	1.9	1.8
PFS HR (95% CI)	0.35 (0.17–0.70)		0.43 (0.31–0.59)		0.58 (0.40–0.84)		0.49 (0.39–0.61)
P value	0.0021		<0.0001		0.0037		<0.0001

Abbreviations: FTD/TPI, trifluridine/tipiracil; HR, hazard ratio; ITT, intention-to-treat; OS, overall survival; PFS, progression-free survival.