Table 2.
Summary of efficacy (triplet regimens shown in bold).
| Characteristic | CO40151 | IPATunity130, Cohort C | IPATunity170 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| PD-L1 status | + | − | Unknown | + | − | Unknown | + | − or unknown | |||
| PIK3CA/AKT1/PTEN status | Unselected | Not altered | Unselected | ||||||||
| Treatment | Atezo + ipat + pac/nab-pac | Atezo + ipat + pac | Atezo + pac | Atezo + ipat + pac | Pac | Ipat + pac | Atezo + ipat + pac | ||||
| Number of patients | 51 | 45 | 18 | 40 | 25 | 37 | 57 | 58 | 41 | 43 | 43 |
| Median duration of follow-up, months (range) | 20.7 (1.0–43.6) | 18.0 (1.8–28.4) | 11.6 (0.3–20.5) | ||||||||
| Number of PFS events (%) | 44 (86) | 39 (87) | 16 (89) | 28 (70) | 22 (88) | 28 (76) | 38 (67) | 41 (71) | 31 (76) | 31 (72) | 29 (67) |
| Median PFS, months (95% CI) | 7.3 (5.4–9.0) | 7.2 (5.4–9.1) | 6.3 (4.9–11.0) | 6.2 (5.4–9.2) | 5.4 (3.7–8.8) | 7.4 (5.5–12.8) | 5.7 (4.0–9.1) | 5.6 (5.4–9.2) | 3.7 (3.6–5.4) | 5.6 (3.7–8.2) | 7.1 (5.1–9.3) |
| ORR, n (%) [95% CI] | 32 (63) | 20 (44) | 9 (50) | 22 (55) | 13 (52) | 19 (51) | 22 (39) | 27 (47) | 6 (15) | 13 (30) | 22 (51) |
| [49–75] | [30–59] | [26–74] | [38–71] | [31–72] | [34–68] | ||||||
| Median DoR, months (95% CI) | 7.4 (5.0–12.9) | 5.6 (3.9–7.8) | 11.1 (7.6–16.7) | 8.7 (5.7–12.7) | 9.2 (5.6–NE) | 9.8 (7.4–14.5) | 7.6 (5.7–NE) | 12.6 (4.2–13.2) | 11.1 (7.4–NE) | ||
| CBR, n (%) [95% CI] | 33 (65) | 27 (60) | 10 (56) | 22 (55) | 13 (52) | 21 (57) | 27 (47) | (n = 57) 28 (49) | 9 (22) | 16 (37) | 23 (53) |
| [51–77] | [45–74] | [32–76] | [38–71] | [31–72] | [39–73] | [34–61] | [36–63] | [11–38] | [23–53] | [38–69] | |
| Deaths, n (%) | 29 (57) | 24 (53) | 6 (33) | 15 (38) | 16 (64) | 18 (49) | 17 (30) | 17 (29) | 13 (32) | 15 (35) | 16 (37) |
| Median OS, months (95% CI) | 23.3 (16.1–39.9) | 28.3 (14.2–42.2) | NE (21.3–NE) | 25.6 (17.9–NE) | 16.7 (10.4–NE) | 22.8 (19.9–NE) | 17.2 (13.4–NE) | NE (14.1–NE) | 16.6 (9.6– NE) | 15.3 (15.3–NE) | 15.7 (12.5–NE) |
Abbreviations: atezo, atezolizumab; ipat, ipatasertib; NE, not estimable; pac, paclitaxel.