Table 3 Clinical activity in patients with measurable disease at baseline (efficacy-evaluable population)
Part 1: pictilisib + paclitaxel ± bevacizumaba | Part 2A: pictilisib + paclitaxel | Part 2B: pictilisib + paclitaxel + bevacizumab | Part 2C: pictilisib + paclitaxel + trastuzumab | Part 3: pictilisib + letrozole | All patients | |
|---|---|---|---|---|---|---|
ORR | ||||||
Best confirmed response, n (%) | n = 19 | n = 17 | n = 13 | n = 6 | n = 3 | n = 58 |
CR | 1 (5.3) | 1 (5.9) | (0.0) | (0.0) | (0.0) | 2 (3.4) |
PR | 4 (21.1) | 3 (17.6) | 7 (53.8) | 2 (33.3) | 1 (33.3) | 17 (29.3) |
SD | 11 (57.9) | 9 (52.9) | 6 (46.2) | 3 (50.0) | 2 (66.7) | 31 (53.4) |
PD | 2 (10.5) | 4 (23.5) | (0.0) | (0.0) | (0.0) | 6 (10.3) |
NE | 1 (5.3) | (0.0) | (0.0) | 1 (16.7) | (0.0) | 2 (3.4) |
DoR | n = 5 | n = 4 | n = 7 | n = 2 | n = 1 | |
Patients with an event, n (%) | 3 (60.0) | 0 (0.0) | 5 (71.4) | 1 (50.0) | 0 (0.0) | – |
Median DoR, months | 8.9 | NE | 8.8 | NE | NE | – |
95% CI | 6.47–11.10 | NE–NE | 4.40–15.34 | 5.36–NE | NE–NE | – |
PFS | n = 20 | n = 18 | n = 15 | n = 9 | n = 7 | |
Patients with an event, n (%) | 13 (65.0) | 10 (55.6) | 10 (66.7) | 5 (55.6) | 5 (71.4) | – |
Median duration of PFS, months | 5.8 | 5.0 | 7.5 | 14.8 | 5.4 | – |
95% CI | 3.52–10.87 | 3.71–NE | 4.60–10.41 | 3.52–16.62 | 1.87–NE | – |