TABLE 2.

PFS rate in total population by biomarker stratification group (tumor tissue) and by PIK3CA cfDNA mutation status (mITT population)

Biomarker stratification group	PIK3CA mut (N = 8)	PTEN loss (N = 2)	Wild‐type (N = 11)	Total population (N = 21)
6‐mo PFS rate, n (%)	5 (62.5)	0 (0.0)	2 (18.2)	7 (33.3)
One‐sided 95% CI	28.9‐100	0.00‐100	3.3‐100	16.8‐100
One‐sided P‐value	0.174	1.000	0.970	0.800

PIK3CA cfDNA mutation status	PIK3CA cfDNA mutation (N = 4)	PIK3CA cfDNA wild‐type (N = 11)	Total population (N = 15)
6‐mo PFS rate, n (%)	2 (50.0)	4 (36.4)	6 (40.0)
One‐sided 95% CI	9.8‐100	13.5‐100	19.1‐100

PFS rate in the total population, in the prespecified subgroups: PIK3CA mut = “PIK3CA mut/ PTEN preserved”; PTEN loss = “PIK3CA mut or wt/ PTEN loss”; wild‐type = “PIK3CA wt/ PTEN preserved” and by PIK3CA cfDNA mutation status. P‐values refer to a one‐sided exact binomial test testing the null hypothesis 6‐mo PFS rate ≤ 0.4.

Abbreviations: CI, confidence interval; mITT, modified intention‐to‐treat; mut, mutant; PFS, progression‐free survival; PI3K, Phosphatidylinositol‐4,5‐bisphosphate 3‐kinase; PIK3CA, Phosphatidylinositol‐4,5‐bisphosphate 3‐kinase, catalytic subunit alpha; PTEN, Phosphatase and tensin homolog; wt, wild‐type