Table 2.
Tumor response by investigator assessment
| All patients | Patients with PIK3CA/AKT1/PTEN-altered tumors | |||||||
|---|---|---|---|---|---|---|---|---|
| Japan subgroup | Global CAPItello-291 population | Japan subgroup | Global CAPItello-291 population | |||||
| Capivasertib–fulvestrant (n = 37) | Placebo–fulvestrant (n = 41) | Capivasertib–fulvestrant (n = 355) | Placebo–fulvestrant (n = 353) | Capivasertib–fulvestrant (n = 19) | Placebo–fulvestrant (n = 19) | Capivasertib–fulvestrant (n = 155) | Placebo–fulvestrant (n = 134) | |
| Number of patients with measurable disease at baseline, n | 34 | 41 | 310 | 320 | 18 | 19 | 132 | 124 |
| Objective response rate, n (%) | 10 (29.4) | 9 (22.0) | 71 (22.9) | 39 (12.2) | 5 (27.8) | 3 (15.8) | 38 (28.8) | 12 (9.7) |
| Odds ratio (95% CI) | 1.48 (0.52–4.21) | 2.19 (1.42–3.36) | 2.05 (0.41–10.24) | 3.93 (1.93–8.04) | ||||
| Best overall response, n | 37 | 41 | 355 | 353 | 19 | 19 | 155 | 134 |
| Complete response | 2 (5.4) | 1 (2.4) | 4 (1.1) | 1 (0.3) | 1 (5.3) | 0 | 3 (1.9) | 0 |
| Partial response | 9 (24.3) | 8 (19.5) | 68 (19.2) | 38 (10.8) | 4 (21.1) | 3 (15.8) | 35 (22.6) | 12 (9.0) |
| Stable disease (≥ 8 weeks) | 21 (56.8) | 27 (65.9) | 187 (52.7) | 152 (43.1) | 11 (57.9) | 13 (68.4) | 84 (54.2) | 55 (41.0) |
| Progressive disease | 4 (10.8) | 5 (12.2) | 83 (23.4) | 149 (42.2) | 3 (15.8) | 3 (15.8) | 31 (20.0) | 62 (46.3) |
| Non-evaluable | 1 (2.7) | 0 | 13 (3.7) | 13 (3.7) | 0 | 0 | 2 (1.3) | 5 (3.7) |
| Clinical benefit rate, n/N (%) |
25/37 (67.6) |
25/41 (61.0) |
182/355 (51.3) |
111/353 (31.4) |
13/19 (68.4) |
11/19 (57.9) |
87/155 (56.1) |
37/134 (27.6) |
| Median duration of response, months (IQR) |
10.2 (3.7–20.3) |
21.4 (9.1–21.4) |
9.8 (5.8–20.3) |
8.4 (5.0–17.6) |
NC (10.2–NC) |
9.2 (9.1–NC) |
9.4 (6.1–19.5) |
8.6 (5.0–9.2) |
AKT1 Akt serine/threonine kinase 1, CI confidence interval, IQR interquartile range, NC not calculable, PIK3CA catalytic subunit of phosphatidylinositol-3-kinase, PTEN phosphatase and tensin homolog, RECIST Response Evaluation Criteria in Solid Tumors