Table 1 Open in new tab The efficacy...

Endpoint	Simtuzumab 700 mg/FOLFIRIn = 84	Simtuzumab 200 mg/FOLFIRIn = 85	Placebo/FOLFIRIn = 80
PFS
KM estimate, months, median (95% CI)	5.5 (4.0, 7.1)	5.4 (3.4, 5.6)	5.8 (4.9, 9.0)
Adjusted HR versus placebo (95% CI)	1.32 (0.92, 1.89)	1.45 (1.01, 2.06)	—
p value versus placebo	.1042	.0395	—
OS
KM estimate, months, median (95% CI)	11.4 (9.7, 15.6)	10.5 (9.2, 12.6)	16.3 (12.0, 19.5)
Adjusted HR versus placebo (95% CI)	1.23 (0.80, 1.91)	1.50 (0.98, 2.30)	—
p value versus placebo	.2451	.0607	—
ORR
CR + PR, n (%)	10 (11.9)	5 (5.9)	8 (10.0)
Difference in ORR from placebo (95% CI), %	2.0 (−8.1, 11.9)	−4.1 (−13.3, 4.6)	—
p value versus placebo	.6904	.3311	—

Endpoint	Simtuzumab 700 mg/FOLFIRIn = 84	Simtuzumab 200 mg/FOLFIRIn = 85	Placebo/FOLFIRIn = 80
PFS
KM estimate, months, median (95% CI)	5.5 (4.0, 7.1)	5.4 (3.4, 5.6)	5.8 (4.9, 9.0)
Adjusted HR versus placebo (95% CI)	1.32 (0.92, 1.89)	1.45 (1.01, 2.06)	—
p value versus placebo	.1042	.0395	—
OS
KM estimate, months, median (95% CI)	11.4 (9.7, 15.6)	10.5 (9.2, 12.6)	16.3 (12.0, 19.5)
Adjusted HR versus placebo (95% CI)	1.23 (0.80, 1.91)	1.50 (0.98, 2.30)	—
p value versus placebo	.2451	.0607	—
ORR
CR + PR, n (%)	10 (11.9)	5 (5.9)	8 (10.0)
Difference in ORR from placebo (95% CI), %	2.0 (−8.1, 11.9)	−4.1 (−13.3, 4.6)	—
p value versus placebo	.6904	.3311	—

Table 1

The efficacy endpoints (FAS analysis set)

Endpoint	Simtuzumab 700 mg/FOLFIRIn = 84	Simtuzumab 200 mg/FOLFIRIn = 85	Placebo/FOLFIRIn = 80
PFS
KM estimate, months, median (95% CI)	5.5 (4.0, 7.1)	5.4 (3.4, 5.6)	5.8 (4.9, 9.0)
Adjusted HR versus placebo (95% CI)	1.32 (0.92, 1.89)	1.45 (1.01, 2.06)	—
p value versus placebo	.1042	.0395	—
OS
KM estimate, months, median (95% CI)	11.4 (9.7, 15.6)	10.5 (9.2, 12.6)	16.3 (12.0, 19.5)
Adjusted HR versus placebo (95% CI)	1.23 (0.80, 1.91)	1.50 (0.98, 2.30)	—
p value versus placebo	.2451	.0607	—
ORR
CR + PR, n (%)	10 (11.9)	5 (5.9)	8 (10.0)
Difference in ORR from placebo (95% CI), %	2.0 (−8.1, 11.9)	−4.1 (−13.3, 4.6)	—
p value versus placebo	.6904	.3311	—

Endpoint	Simtuzumab 700 mg/FOLFIRIn = 84	Simtuzumab 200 mg/FOLFIRIn = 85	Placebo/FOLFIRIn = 80
PFS
KM estimate, months, median (95% CI)	5.5 (4.0, 7.1)	5.4 (3.4, 5.6)	5.8 (4.9, 9.0)
Adjusted HR versus placebo (95% CI)	1.32 (0.92, 1.89)	1.45 (1.01, 2.06)	—
p value versus placebo	.1042	.0395	—
OS
KM estimate, months, median (95% CI)	11.4 (9.7, 15.6)	10.5 (9.2, 12.6)	16.3 (12.0, 19.5)
Adjusted HR versus placebo (95% CI)	1.23 (0.80, 1.91)	1.50 (0.98, 2.30)	—
p value versus placebo	.2451	.0607	—
ORR
CR + PR, n (%)	10 (11.9)	5 (5.9)	8 (10.0)
Difference in ORR from placebo (95% CI), %	2.0 (−8.1, 11.9)	−4.1 (−13.3, 4.6)	—
p value versus placebo	.6904	.3311	—

^aStratified primary analysis per investigator assessment. The results per Independent Review Committee were similar to those obtained by investigator assessment.

^bp values based on stratified two‐sided log‐rank test.

^cp values based on Cochran–Mantel–Haenszel test adjusted for stratification factors.

Abbreviations: CI, confidence interval; CR, complete response; FAS, full analysis set (all patients randomized and treated with ≥1 dose of study drug); HR, hazard ratio; KM, Kaplan–Meier; ORR, objective response rate; OS, overall survival; PFS, progression‐free survival; PR, partial response.

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