Table 2.

Comparison of the Baseline Demographic and Disease Characteristics Between the External-Control Arm Derived From the IMblaze370 and the MORPHEUS-CRC Control and Experimental Arms.

	IMblaze370	MORPHEUS-CRC		P value (EC vs Atezo + Isa)	SMD (EC vs Atezo + Isa)
	Regorafenib (EC)	Atezo + Isa	Regorafenib
Total Sample size	28	15	13
Age at baseline, mean (SD)	57.0 (9.6)	52.2 (12.0)	59.5 (10.5)	0.178	0.445
Sex, No. (%)				0.859	0.058
Female	12 (42.9)	6 (40.0)	7 (53.8)
Male	16 (57.1)	9 (60.0)	6 (46.2)
Race, No. (%)				0.362	0.306
White	21 (84.0)	10 (71.4)	8 (66.7)
Non-White	4 (16.0)	4 (28.6)	4 (33.3)
Unknown	3	1	1
Region, No. (%)				0.002	1.498
North America	6 (21.4)	11 (73.3)	6 (46.2)
Europe	17 (60.7)	1 (6.7)	2 (15.4)
Asia-Pacific	5 (17.9)	3 (20.0)	5 (38.5)
Time from metastatic diagnosis to baseline, No. (%)				0.161	0.464
<18 months	7 (25.0)	7 (46.7)	4 (30.8)
≥18 months	21 (75.0)	8 (53.3)	8 (61.5)
Unknown	0	1	0
ECOG, No. (%)				0.417	0.27
0	13 (46.4)	5 (33.3)	6 (46.2)
1	15 (53.6)	10 (66.7)	7 (53.8)
RAS, No. (%)				0.924	0.032
Wild type	10 (38.5)	6 (40.0)	8 (61.5)
Mutant	16 (61.5)	9 (60.0)	5 (38.5)
Unknown	2	0	0
Liver metastases, No. (%)				0.786	0.088
No	10 (35.7)	6 (40.0)	4 (30.8)
Yes	18 (64.3)	9 (60.0)	9 (69.2)

Statistical differences between the external-control and the MORPHEUS experimental arm (atezolizumab + isatuximab) were assessed using (1) P values calculated via the 2-tailed χ2 (or Fisher exact) test for all categorical variables or the Wilcoxon rank-sum test for the age variable, and (2) standardized mean difference.

Atezo atezolizumab, EC external control, ECOG Eastern Cooperative Oncology Group, Isa isatuximab, RAS Rat Sarcoma proto-oncogene.