Table 3.
Summary of safety (triplet regimens shown in bold).a
| Number of patients with AE (%) | 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 |
| Grade ≥3 AE | 33 (65) | 23 (51) | 9 (50) | 21 (53) | 14 (56) | 27 (73) | 20 (35) | 39 (67) | 15 (37) | 23 (53) | 29 (67) |
| Grade 5 AE | 2 (4) | 0 | 0 | 0 | 2 (8) | 2 (5) | 0 | 3 (5) | 1 (2) | 1 (2) | 3 (7) |
| Serious AE | 24 (47) | 17 (38) | 3 (17) | 8 (20) | 10 (40) | 11 (30) | 9 (16) | 15 (26) | 7 (17) | 7 (16) | 14 (33) |
| AE leading to treatment discontinuation | |||||||||||
| Ipatasertib/placebo | 1 (2) | 4 (9) | 2 (11) | 4 (10) | 1 (4) | 6 (16) | 1 (2) | 8 (14) | 1 (2) | 3 (7) | 5 (12) |
| Atezolizumab/placebo | 1 (2) | 3 (7) | 1 (6) | 4 (10) | 1 (4) | 8 (22) | 0 | 7 (12) | 1 (2) | 2 (5) | 2 (5) |
| Taxane | Pac: 15 (29) | Pac: 13 (29) | Pac: 5 (28) | 6 (15) | 3 (12) | 13 (35) | 3 (5) | 13 (22) | 4 (10) | 6 (14) | 4 (9) |
| Nab-pac: 3 (6) | Nab-pac: 1 (2) | Nab-pac: 0 | |||||||||
aAEs graded according to NCI CTCAE version 4.0 for CO40151 and IPATunity130 and version 5.0 for IPATunity170 and coded using MedDRA version 24.1.
Abbreviations: atezo, atezolizumab; ipat, ipatasertib; MedDRA, Medical Dictionary for Regulatory Activities; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; pac, paclitaxel.