Table 4.
Efficacy summary across the 3 dose groups
| Endpoint or category | 120 3/4 | 160 3/4 | 160 3/4, 2/1w | All patients |
|---|---|---|---|---|
| (n = 23) | (n = 65) | (n = 26) | (n = 114) | |
| Best response by RECIST v1.1, no. (%) | ||||
| cCR | 0 | 0 | 1 (3.8) | 1 (0.9) |
| cPR | 1 (4.3) | 3 (4.6) | 3 (11.5) | 7 (6.1) |
| uCR or uPR | 0 | 3 (4.6) | 0 | 3 (2.6) |
| Overall response (RECIST only), no. (%, 95% CI) | 1 (4.3, 0.1 to 21.9) | 6 (9.2, 3.5 to 19.0) | 4 (15.4, 4.4 to 34.9) | 11 (9.6, 4.9 to 16.6) |
| Overall response (RECIST or tumor marker), no. (%, 95% CI) | 2 (8.7, 1.1 to 28.0) | 6 (9.2, 3.5 to 19.0) | 5 (19.2, 6.6 to 39.4) | 13 (11.4, 6.2 to 18.7) |
| Clinical benefit,a no. (%, 95% CI) | 8 (34.8, 16.4 to 57.3) | 24 (36.9, 25.3 to 49.8) | 12 (46.2, 26.6 to 66.6) | 44 (38.6, 29.6 to 48.2) |
| Medianb PFS, weeks (95% CI) | 13.4 (7.00 to 37.00) | 16.1 (11.43 to 17.71) | 14.7 (6.14 to 27.29) | 14.7 (12.14 to 17.71) |
| PFS at 24 weeks, % (95% CI) | 38.9 (18.0 to 59.5) | 25.2 (14.5 to 37.4) | 45.0 (25.3 to 62.8) | 33.1 (24.0 to 42.5) |
| Molecular response (ctDNA reduction of 50% or more) | ||||
| Evaluable ctDNA for monitoring | 17 | 25 | 10 | 52 |
| Molecular response, response/evaluable (%) | 4/17 (23.5) | 10/25 (40.0) | 3/10 (30.0) | 17/52 (32.7) |
a
Defined as overall response, or duration of treatment of at least 16 weeks without progressive disease. 2/1w = 2 weeks on, 1 week off; 120 3/4 = 120 mg QD 3 days on, 4 days off; 160 3/4 = 160 mg QD 3 days on, 4 days off; CA-125 = cancer antigen 125; cCR = confirmed complete response; CI = confidence interval; cPR = confirmed partial response; ctDNA = circulating tumor DNA; PFS = progression-free survival; PSA = prostate-specific antigen; QD = once daily; RECIST = Response Evaluation Criteria in Solid Tumors; uCR, unconfirmed complete response; uPR = unconfirmed partial response.