Table 2.
Secondary and Exploratory Efficacy Endpoints.
| TALA | Overall PCT | |
|---|---|---|
| Best overall response (measurable disease) a | n = 219 | n = 114 |
| Complete response, No. (%) | 12 (5.5) | 0 |
| Partial response, No. (%) | 125 (57.1) | 31 (27.2) |
| Stable disease, No. (%) | 46 (21.0) | 36 (31.6) |
| Nonevaluable, No. (%) | 4 (1.8) | 19 (16.7) |
| Objective response by investigator (measurable disease) a | n = 219 | n = 114 |
| ORR, % (95% CI) | 62.6 (55.8, 69.0) | 27.2 (19.3, 36.3) |
| Odds ratio (95% CI); 2-sided P valueb | 4.99 (2.9, 8.8); P<0.0001 | |
| Clinical benefit rate at 24 weeks (CBR24; ITT) | n = 287 | n = 144 |
| CBR24, % (95% CI) | 68.6 (62.9, 74.0) | 36.1 (28.3, 44.5) |
| Odds ratio (95% CI); 2-sided P valueb | 4.28 (2.69, 6.83); P<0.0001 | |
| DOR by investigator (subgroup with objective response) | n = 137 | n = 31 |
| Median (IQR), mo | 5.4 (2.8–11.2) | 3.1 (2.4–6.7) |
Abbreviations: CI = confidence interval; CBR24 = Clinical benefit rate at 24 weeks; DOR = duration of response; ITT = intent to treat; IQR = interquartile range; ORR = overall response rate; RECIST = Response Evaluation Criteria in Solid Tumors; TALA = talazoparib.
a
Per RECIST version 1.1, confirmation of complete response or partial response was not required.
b
CMH=Cochran-Mantel-Haenszel.