. 2022 Nov 17;9(1):40–50. doi: 10.1001/jamaoncol.2022.5228

Table 2. Best Overall Response, Confirmed Objective Response, and Progression-Free Survival in the Dose-Finding Phase and Dose-Expansion Cohorts.

Outcome	Patients, No. (%)
Outcome	Dose-finding phase (n = 12)	NSCLC (n = 42)	DDR+ NSCLC (n = 5)	TNBC (n = 22)	HR+, ERBB2−, DDR+ BC (n = 23)	OC (n = 20)	BRCA-alt OC (n = 11)	UC (n = 40)	mCRPC (n = 21)	DDR+ mCRPC (n = 18)	BRCA/ATM alt (n = 9)
Best overall response^a
CR	1 (8.3)	0	0	1 (4.5)	1 (4.3)	0	2 (18.2)	1 (2.5)	0	0	0
PR	1 (8.3)	7 (16.7)	1 (20.0)	3 (13.6)	7 (30.4)	4 (20.0)	5 (45.5)	5 (12.5)	0	2 (11.1)	1 (11.1)
Stable disease	3 (25.0)	24 (57.1)	1 (20.0)	8 (36.4)	8 (34.8)	15 (75.0)	4 (36.4)	15 (37.5)	7 (33.3)	5 (27.8)	1 (11.1)
Non-CR or non-PD	1 (8.0)	0	0	0	0	0	0	0	8 (38.1)	2 (11.1)	0
PD	5 (41.7)	7 (16.7)	3 (60.0)	10 (45.5)	7 (30.4)	1 (5.0)	0	14 (35).0	6 (28.6)	6 (33.3)	3 (33.3)
Not evaluable	1 (8.3)	4 (9.5)	0	0	0	0	0	5 (12.5)	0	3 (16.7)	4 (44.4)
Patients with OR, % (95% CI)	16.7 (2.1-48.4)	16.7 (7.0-31.4)^a	20.0 (0.5-71.6)^a	18.2 (5.2-40.3)^a	34.8 (16.4-57.3)^a	20.0 (5.7-43.7)^a	63.6 (30.8-89.1)^a	15.0 (5.7-29.8)^a	0 (0-16.1)^b	11.1 (1.4-34.7)^b	11.1 (0.3-48.2)^a^,^b
Time to response, median (range), mo	NA (1.8-1.8)^c	3.7 (1.7-11.3)	1.8 (1.8-1.8)^d	1.8 (1.6-2.0)	1.9 (1.6-3.6)	3.6 (1.7-17.9)	1.7 (1.6-3.7)	2.1 (1.4-5.9)	NA	NA (5.4-5.6)^c	1.8 (1.8-1.8)^d
Duration of response, median (95% CI), mo	NE (3.7-31.9)^c	17.5 (5.4-17.5)	NE (11.1)^d	11.1 (3.4-20.4)	15.7 (3.9-NE)	3.9 (3.7-5.5)	NR (5.6-NE)	NR	NA	NA (4.3-5.5)^c	NE (9.13)^d
PFS, median (95% CI), months^a	NA (NC)	4.7 (3.7-7.4)	1.9 (1.8-NE)	3.6 (1.9-5.6)	5.3 (2.0-12.8)	7.2 (4.0-9.1)	NR (7.2-NE)	3.6 (1.9-5.4)	4.1 (1.9-NE)	4.6 (1.7-9.8)	1.8 (1.4-5.9)
Probability of no disease progression, % (95% CI)
At 4 mo	NA	53.2 (36.2-67.5)^a	20.0 (0.8-58.2)^a	45.0 (23.9-64.1)^a	52.2 (30.5-70.0)^a	79.7 (54.5-91.9)^a	90.9 (50.8-98.7)^a	36.5 (21.6-51.6)^a	33.3 (7.8-62.3)^b	58.8 (32.0-78.1)^b	53.3 (26.3-74.4)^a^,^b
At 6 mo	NA	42.0 (26.1-57.1)^a	20.0 (0.8-58.2)^a	20.0 (6.3-39.1)^a	33.8 (15.6-53.1)^a	53.1 (29.2-72.3)^a	90.9 (50.8-98.7)^a	25.0 (12.4-39.8)^a	16.7 (1.1-49.3)^b	35.3 (10.1-62.3)^b	40.0 (16.5-62.8)^a^,^b
At 8 mo	NA	27.0 (137-42.1)^a	20.0 (0.8-58.2)^a	15.0 (3.8-33.3)^a	33.8 (15.6-53.1)^a	37.2 (16.7-57.8)^a	72.7 (37.1-90.3)^a	17.8 (7.1-32.5)^a	16.7 (1.1-49.3)^b	35.3 (10.1-62.3)^b	33.3 (12.2-56.4)^a^,^b
At 10 mo	NA	18.0 (7.4-32.3)^a	20.0 (0.8-58.2)^a	15.0 (3.8-33.3)^a	33.8 (15.6-53.1)^a	26.6 (9.7-47.1)^a	63.6 (29.7-84.5)^a	17.8 (7.1-32.5)^a	16.7 (1.1-49.3)^b	35.3 (10.1-62.3)^b	26.7 (8.3-49.6)^a^,^b
At 12 mo	NA	18.0 (7.4-32.3)^a	20.0 (0.8-58.2)^a	10.0 (1.7-27.1)^a	33.8 (15.6-53.1)^a	21.3 (6.6-41.3)^a	54.5 (22.9-78.0)^a	17.8 (7.1-32.5)^a	NE (NE-NE)	17.6 (1.2-50.4)^b	13.3 (2.2-34.6)^a^,^b
At 18 mo	NA	10.8 (3.0-24.3)^a	NE (NE-NE)	5.0 (0.3-20.5)^a	18.8 (4.3-41.0)^a	15.9 (4.0-35.2)^a	54.5 (22.9-78.0)^a	NE (NE-NE)	NE (NE-NE)	NE (NE-NE)	NE (NE-NE)
Duration of treatment, median, (IQR) [range], mo
Avelumab	4.8 (2.4-7.7) [0.9-35.0]	4.6 (2.8-9.2) [0.5-24.4]	1.9 (1.8-10.6) [1.8-16.1]	3.9 (2.0-6.6) [1.4-21.4]	5.5 (2.7-13.8) [0.9-23.2]	7.0 (5.5-9.8) [1.8-23.2]	12.6 (9.2-21.2) [3.2-23.8]	3.6 (1.8-8.7) [0.5-18.3]	3.7 (1.8-4.1) [0.5-12.4]	3.2 (1.8-9.9) [0.5-17.0]	2.7 (1.1-5.9) [0.5-11.4]
Talazoparib	3.9 (1.7-7.6) [0.9-34.7]	4.1 (2.1-7.8) [0.3-24.8]	1.8 (1.8-10.5) [1.8-16.0]	3.5 (1.9-6.6) [1.3-21.4]	5.3 (2.3-13.8) [0.9-22.9]	7.0 (5.5-10.9) [1.6-23.0]	12.2 (9.2-21.1) [3.2-23.6]	3.8 (1.6-7.9) [0.4-18.3]	3.4 (1.9-4.1) [0.4-12.4]	3.5 (1.8-9.9) [0.0-16.8]	2.3 (0.9-6.0) [0.3-11.5]

Abbreviations: −, negative; +, positive; alt, altered; BC, breast cancer; CR, complete response; DDR, DNA damage repair deficient; ERBB2, human epidermal growth factor receptor 2; HR, hormone receptor; mCRPC, metastatic castration-resistant prostate cancer; NA, not available; NC, not calculable; NE, not estimable; NR, not reached; NSCLC, non–small-cell lung cancer; OC, ovarian cancer; OR, objective response; PD, progressive disease; PFS, progression-free survival; PR, partial response; TNBC, triple-negative BC; UC, urothelial carcinoma.

^{^a}

Assessed by investigators per Response Evaluation Criteria in Solid Tumors version 1.1 for patients with BRCA1/2- or ATM-altered solid tumors without mCRPC.

^{^b}

Assessed by investigators per Response Evaluation Criteria in Solid Tumors version 1.1 and Prostate Cancer Working Group 3 patients with BRCA1/2- or ATM-altered solid tumors with mCRPC.

^{^c}

Raw values for the 2 responders in the cohort.

^{^d}

Raw values for 1 responder in the cohort.