Table 4.

Summary of PFS and overall survival by subgroups (mITT RP2D population)

Subgroup	PFS				Overall survival
	N a	mPFS (months)	90% CIb	P-value	Nc	mOS (months)	90% CIb	P-value
Whole	52	6.7	(4.5, 11.5)		53	13.1	(11.5, 24.5)	–
Age group
18–64 years	39	6	(4.5, 12.4)	0.440	40	14	(12.3, NE)	0.063
65+ years	13	10	(2.7, 11.5)		13	11	(4.3, 24.5)	–
Extent of surgery
Complete resection	23	6	(4.2, 12.3)	0.699	23	14	(9.9, 24.5)	0.969
Partial resection	26	9	(4.5, 15.4)		27	13	(7.9, NE)	–
Baseline KPS score
70–89	18	4	(2.6, 4.5)	0.003	18	8	(6.9, 12.4)	<0.001
90–100	34	11	(6.2, 14.7)		35	24	(13.1, NE)	–
MGMT statusd
Methylated	23	10	(5.2, 15.4)	0.201	23	15	(9.7, NE)	0.501
Unmethylated	27	4	(3.9, 10.2)		27	12	(7.9, 20.7)	–

Abbreviations: CI = confidence interval; KPS = Karnofsky Performance Scale; MGMT = O₆-methylguanine-DNA methyltransferase; mITT = modified intention-to-treat; mPFS = median progression-free survival; mOS = median overall survival; N = number of patients with data that apply or data available; NE = not estimable; RP2D = recommended Phase 2 dose.

^aSubject 026_010 voluntarily withdrew after 29 days on study and did not have an MRI after screening, so was not evaluable for PFS.

^b90% CI is calculated based on Kaplan–Meier methodology.

^cSubject 020_011 continues to participate in the study but was censored on November 03, 2017.

^dMGMT methylation status was known for 50 patients.