Table 2.
Primary and secondary efficacy endpoints in the efficacy analysis set by IRC
| TNBC cohort (n = 55) |
HR+/HER2− cohort (n = 21) |
|
|---|---|---|
| Confirmed ORR, n (%) [95% CI] | 21 (38.2) [25.4–52.3] | 13 (61.9) [38.4–81.9] |
| Confirmed best overall response, n (%) | ||
| CR | 3 (5.5) | 1 (4.8) |
| PR | 18 (32.7) | 12 (57.1) |
| SD | 19 (34.5) | 6 (28.6) |
| PD | 15 (27.3) | 2 (9.5) |
| Disease control rate (CR + PR + SD), n (%) [95% CI] | 40 (72.7) [59.0–83.9] | 19 (90.5) [69.6–98.8] |
| Clinical benefit rate (CR + PR + durablea SD), n (%) [95% CI] | 24 (43.6) [30.3–57.7] | 15 (71.4) [47.8–88.7] |
| DoR | ||
| Events, n (%) | 11 (20.0) | 10 (47.6) |
| Median, months (95% CI)b | 7.0 (3.9–NE) | 7.5 (5.6–14.8) |
Data cutoff: October 9, 2020
CI confidence interval, CR complete response, DoR duration of response, HER2- human epidermal growth factor receptor 2-negative, HR + hormone receptor-positive, IRC independent review committee, NE not estimable, ORR objective response rate, PD progressive disease, PR partial response, SD stable disease, TNBC triple-negative breast cancer
aDurable SD was defined as lasting ≥ 24 weeks
bMedians were estimated by the Kaplan–Meier method, with 95% CIs estimated using the method of Brookmeyer and Crowley