Table 4.
Summary of investigator-assessed best overall response (RECIST v1.1 criteria).
| Best overall response | Molibresib 60 mg + FUL 500 mg (AI failure) (n = 33) | Molibresib 60 mg + FUL 500 mg (CDK4/6i + AI failure <12 mo) (n = 12) | Molibresib 60 mg + FUL 500 mg (CDK4/6i + AI failure ≥12 mo) (n = 42) | Molibresib 60 mg + FUL 500 mg (CDK4/6i + AI failure ≥12 mo bone-only disease) (n = 7) | Molibresib 80 mg + FUL 500 mg (AI failure) (n = 18) | Molibresib 80 mg + FUL 500 mg (CDK4/6i + AI failure) (n = 11) | Total (N = 123) |
|---|---|---|---|---|---|---|---|
| CR confirmed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| CR unconfirmed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PR confirmed | 7 (21%) | 0 | 5 (12%) | 0 | 3 (17%) | 1 (9%) | 16 (13%) |
| PR unconfirmed | 1 (3%) | 0 | 3 (7%) | 0 | 0 | 0 | 4 (3%) |
| SD | 15 (45%) | 2 (17%) | 12 (29%) | 4 (57%) | 8 (44%) | 3 (27%) | 44 (36%) |
| PD | 7 (21%) | 8 (67%) | 19 (45%) | 1 (14%) | 5 (28%) | 7 (64%) | 47 (38%) |
| NE | 1 (3%) | 2 (17%) | 1 (2%) | 1 (14%) | 1 (6%) | 0 | 6 (5%) |
| ORR | |||||||
| CR + PR | 7 (21%) | 0 | 5 (12%) | 0 | 3 (17%) | 1 (9%) | 16 (13%) |
| 95% CI | (9.0–38.9) | (0.0–26.5) | (4.0–25.6) | (0.0–41.0) | (3.6–41.4) | (0.2–41.3) | (7.6–20.3) |
| DCR (CR + PR + SD) | 12 (36%) | 0 | 7 (17%) | 1 (14%) | 5 (28%) | 1 (9%) | |
| 95% CI | (20.4–54.9) | (0.0–26.5) | (7.0–31.4) | (0.4–57.9) | (9.7–53.5) | (0.2–41.3) | |
Abbreviations: AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; CR, complete response; DCR, disease control rate; FUL, fulvestrant; NE, not evaluable; ORR, objective response rate; PD, progressive disease, PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.