Table 5.
Summary of PFS.
| 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) | |
|---|---|---|---|---|---|---|---|
| Number of patients (N) | 33 | 12 | 42 | 7 | 18 | 11 | 123 |
| Event | 26 (79%) | 10 (83%) | 32 (76%) | 3 (43%) | 14 (78%) | 10 (91%) | 95 (77%) |
| Censored | 7 (21%) | 2 (17%) | 10 (24%) | 4 (57%) | 4 (22%) | 1 (9%) | 28 (23%) |
| Event summary | |||||||
| PD per RECIST v1.1 | 26 (79%) | 10 (83%) | 31 (74%) | 3 (43%) | 13 (72%) | 10 (91%) | 93 (76%) |
| Death due to any cause | 0 | 0 | 1 (2%) | 0 | 1 (6%) | 0 | 2 (2%) |
| PFS (mo) | |||||||
| 1st quartile 95% CI | 3.5 (1.7–4.2) | 1.6 (0.7–1.7) | 1.7 (1.6–1.8) | 3.7 (1.8–7.2) | 1.8 (1.6–5.9) | 1.7 (1.4–1.8) | 1.7 (1.7–1.8) |
| Median 95% CI | 5.6 (3.7–11.1) | 1.7 (1.6–2.1) | 2.1 (1.8–3.6) | 7.2 (1.8–NR) | 4.0 (1.8–9.4) | 1.8 (1.7–3.6) | 3.6 (1.9–4.0) |
| 3rd quartile 95% CI | 14.1 (5.8–20.5) | 2.1 (1.7–6.1) | 7.1 (3.5–9.2) | NR (3.7–NR) | 9.4 (4.0–15.7) | 3.6 (1.8–11.4) | 7.7 (5.6–11.4) |
Note: PFS is defined as the time interval from date of first dose to date of first documented PD, as assessed by the investigator per RECIST v1.1 criteria, or to the date of death due to any cause.
Abbreviations: AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; FUL, fulvestrant; NR, no result; PD, progressive disease; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.