Table 2 Phase 2/3 key clinical trials of targeted PI3K/AKT/mTOR pathways agents for patients with HR+/HER2− locally advanced or metastatic breast cancer
Target | Trial | Agent | Phase | No. of patients | Line of therapy | Arms | PFS (p) | OS (p) | References |
|---|---|---|---|---|---|---|---|---|---|
PI3K | SANDPIPER | Taselisib | 3 | 516 | Prior ET | TAS + FUL vs. PBO + FUL | 7.4 vs. 5.4 months; Hazard ratio: 0.70 (p = 0.0037) | NA | |
SOLAR‐1 | Alpelisib | 3 | 341 | Prior ET | ALP + FUL vs. PBO + FUL | 11.0 vs. 5.7 months; Hazard ratio: 0.65 (p < 0.001) | 39.3 vs. 31.4 months; Hazard ratio: 0.86 (p = 0.15) | ||
BYLieve | Alpelisib | 2 | 121 | Prior ET + CDK4/6i | ALP + FUL | 7.3 months | 17.3 months | ||
INAVO120 | Inavolisib | 3 | 325 | Fist line | PALBO + FUL + INA vs. PALBO + FUL + PBO | 15.0 vs. 7.3 months; Hazard ratio: 0.43 (p < 0.0001) | NA | ||
AKT | FAKTION | Capivasertib | 3 | 140 | Prior ET | FUL + CAP vs. PBO + CAP | 10.3 vs. 4.8 months; Hazard ratio: 0.58 (p = 0.0044) | 29.3 vs. 23.4 months; Hazard ratio: 0.66 (p = 0.035) | |
CAPItello-291 | Capivasertib | 3 | 708 | Prior ET ± CDK4/6i | CAP + FUL vs. PBO + FUL | 7.2 vs. 3.6 months; Hazard ratio: 0.60 (p <0.001) | NA | ||
IPATunity130, cohort B | Ipatasertib | 3 | 222 | No prior CT for ABC or relapse >1 year of NAC | IPAT + PAC vs. PBO + PAC | 9.3 vs. 9.3 months; Hazard ratio: 1.00 | NA | ||
mTOR | TAMRAD | Everolimus | 2 | 111 | Prior ET | EVE + TAM vs. TAM | 8.6 vs. 4.5 months; Hazard ratio: 0.54 | NA | |
BOLERO‐2 | Everolimus | 3 | 724 | Prior ET | EVE + EXE vs. PBO + EXE | 7.8 vs. 3.2 months; Hazard ratio: 0.45 (p < 0.0001) | 31.0 vs. 26.6 months; Hazard ratio: 0.89 (p = 0.14) | ||
PrE0102 | Everolimus | 2 | 131 | Prior ET | FUL + EVE vs. FUL+ PBO | 10.3 vs. 5.1 months; Hazard ratio: 0.61 (p = 0.02) | NA |
