Table 3.
Treatment Efficacy for Patients With ER+ HER2− AKT1E17K-Mutant Metastatic Breast Cancer
| Capivasertib Monotherapy |
Capivasertib + Fulvestrant Combination (N=43) |
All Capivasertib-Treated Patients (N=63) |
||||
|---|---|---|---|---|---|---|
| Breast-Specific Cohort (N=20) |
Fulvestrant Naïve (n=15) |
Fulvestrant Pretreated (n=28) |
Fulvestrant Naïve (n=21) |
Fulvestrant Pretreated (n=42) |
Total (n=63) |
|
| Objective responsea | ||||||
| ORR, % (95% CI) | 20 (8–58) | 20 (4–48) | 36 (19–56) | 14 (3–36) | 33 (20–50) | 27 (17–40) |
| Complete response, n (%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Partial response, n (%) | 4 (20) | 3 (20) | 10 (36) | 3 (14) | 14 (33) | 17 (27) |
| DOR ≥6 months, n (%) | 2 (10) | 3 (20) | 8 (29) | 3 (14) | 10 (24) | 13 (21) |
| Stable disease 24 weeks, n (%) | 5 (25) | 4 (27) | 4 (14) | 6 (29) | 7 (17) | 13 (21) |
| Clinical benefit rate at 24 weeks, % (95% CI)b | 45 (23–69) | 47 (21–73) | 50 (31–69) | 43 (22–66) | 50 (34–66) | 48 (35–61) |
| Median PFS, months (95% CI) | 5.4 (3–7) | 5.6 (2–14) | 5.0 (3–8) | 5.4 (3–10) | 5.0 (4–7) | 5.4 (4–7) |
Response is based on investigator tumor assessments in accordance with RECIST v1.1 in patients with measurable disease.
a
Confirmed no fewer than 4 weeks after the criteria for response were initially met
b
Clinical benefit defined as confirmed best overall response of complete response, partial response, or stable disease for at least 24 weeks. CI, confidence interval; DOR, duration of response; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; ORR, objective response ratio; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.